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The Effectiveness of Psychosocial Interventions for Women with Breast Cancer

Health-care providers are offering and women are seeking arange of interventions to manage psychosocial distress following a diagnosis of breast cancer, but there is no strong evidence-based consensus indicating which interventions are effective in reducing distress and improving quality of life. This chapter provides a critical review of the most relevant and highest quality studies of the effectiveness of psychosocial interventions in breast cancer. Included are published randomized trials and selected non-randomized studies that were designed to evaluate the effectiveness of psychosocial interventions for women with breast cancer.1 Excluded is the psychosocial literature in other cancers or in mixed groups of cancer patients, in which only some patients have breast cancer. Also not covered is the extensive literature relating to psychological issues surrounding breast cancer screening or identification of high-risk individuals. The effectiveness of the treatment of mental disorders such as major depression is not examined, although, according to a recent review, pharmacologic treatment of cancer patients who are clinically depressed is effective if antidepressants are administered appropriately (Agency for Healthcare and Research and Quality, 2002). Underlying psychiatric disorders may worsen

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This chapter is based on a commissioned paper by Pamela J. Goodwin, M.D., M.Sc., FRCPC, Marvelle Koffler Breast Centre, Department of Medicine, Division of Epidemiology, Samuel Lunenfeld Research Institute, Mount Sinai Hospital, University of Toronto and presented at the National Cancer Policy Board workshop “Meeting Psychosocial Needs of Women with Breast Cancer”on October 28–29, 2002, at the Institute of Medicine in Washington, DC.



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Meeting Psychosocial Needs of Women with Breast Cancer 5 The Effectiveness of Psychosocial Interventions for Women with Breast Cancer Health-care providers are offering and women are seeking arange of interventions to manage psychosocial distress following a diagnosis of breast cancer, but there is no strong evidence-based consensus indicating which interventions are effective in reducing distress and improving quality of life. This chapter provides a critical review of the most relevant and highest quality studies of the effectiveness of psychosocial interventions in breast cancer. Included are published randomized trials and selected non-randomized studies that were designed to evaluate the effectiveness of psychosocial interventions for women with breast cancer.1 Excluded is the psychosocial literature in other cancers or in mixed groups of cancer patients, in which only some patients have breast cancer. Also not covered is the extensive literature relating to psychological issues surrounding breast cancer screening or identification of high-risk individuals. The effectiveness of the treatment of mental disorders such as major depression is not examined, although, according to a recent review, pharmacologic treatment of cancer patients who are clinically depressed is effective if antidepressants are administered appropriately (Agency for Healthcare and Research and Quality, 2002). Underlying psychiatric disorders may worsen 1   This chapter is based on a commissioned paper by Pamela J. Goodwin, M.D., M.Sc., FRCPC, Marvelle Koffler Breast Centre, Department of Medicine, Division of Epidemiology, Samuel Lunenfeld Research Institute, Mount Sinai Hospital, University of Toronto and presented at the National Cancer Policy Board workshop “Meeting Psychosocial Needs of Women with Breast Cancer”on October 28–29, 2002, at the Institute of Medicine in Washington, DC.

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Meeting Psychosocial Needs of Women with Breast Cancer or be exacerbated following a diagnosis of cancer, and psychopharmacologic treatment can reduce distress and improve quality of life. The chapter begins with a brief history of psychosocial intervention research in breast cancer followed by a discussion of methodological issues that are crucial to assessing the effectiveness of psychosocial interventions. An enumeration of research priorities to address identified knowledge gaps is outlined in Chapter 8. HISTORY OF PSYCHOSOCIAL INTERVENTION RESEARCH In the past decade, considerable resources have been allocated to research into the psychosocial aspects of breast cancer. Much of this research has focused on describing the emotional experience of women with breast cancer and developing interventions that reduce the psychosocial distress and improve coping and adjustment. Early intervention studies were done by Ferlic and colleagues (1979) and by Heinrich and Schag (1985), both with positive psychosocial results. A report by David Spiegel et al. that appeared in The Lancet in 1989 suggested, for the first time, that a psychological intervention (supportive–expressive group therapy) might prolong survival in women living with metastatic breast cancer (Spiegel et al., 1989). This observation heightened interest in survival effects of psychosocial interventions and led to a series of intervention studies in breast cancer (Classen et al., 2001; Cunningham et al., 1998; Edelman et al., 1999a; Goodwin et al., 2001) and other cancers (Fawzy et al., 1993; Ilnyckyj et al., 1994; Kuchler et al., 1999; Linn et al., 1982), conducted mainly in the 1990s. These studies attempted to confirm a beneficial effect of psychological interventions on survival. None of the subsequent studies in metastatic breast cancer has identified a survival effect of a range of psychological interventions (although one is ongoing) (Cunningham et al., 1998; Edelman et al., 1999a; Edmonds et al., 1999; Goodwin et al., 2001). Three studies in other malignancies (leukemia, melanoma, and mixed GI cancers) have reported survival benefits for brief interventions, delivered around the time of or shortly after diagnosis or during treatment (Fawzy et al., 1993; Kuchler et al., 1999, Richardson et al., 1990). These results have not been replicated. Nonetheless, throughout much of the 1990s, the focus of some members of the psycho-oncology research community shifted from evaluation of psychological effects of interventions to survival and intermediate biomedical effects, including enhancement of immune function. A growing recognition has developed that the survival effect in metastatic breast cancer that was seen by Spiegel et al. (Spiegel et al., 1989) has not been replicated and that little evidence supports the prognostic importance of intermediate outcomes such as cortisol levels that have been linked to psychosocial interventions, although it has been suggested that the Spiegel study at least indicated

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Meeting Psychosocial Needs of Women with Breast Cancer that these kinds of psychosocial interventions did not damage patients’ coping skills in a way that would limit survivals. Spiegel has undertaken a replication study currently in progress. Research focus is once again returning to the psychological status and quality of life of women with breast cancer, and to the identification of interventions that favorably influence their psychological and social functioning. An example is the report by Kissane and colleagues (2003) of a randomized, controlled trial of cognitive–existential group therapy for women with early breast cancer. It found the women in the intervention group showed significantly lower anxiety, and improved family function. The authors reported self-growth and increased knowledge of cancer and its treatment. A number of excellent reviews of psychosocial interventions in breast cancer, and cancer in general, have been published recently (Burke and Kissane, 1998; Fawzy et al., 1995; Meyer and Mark, 1995; Newell et al., 2002; Rimer et al., 1985; Wallace, 1997). The majority of these reviews concluded that there are important benefits associated with the use of psychological interventions of various types in various cancer settings, including breast cancer. Fawzy et al. reviewed research into education, behavioral training, individual psychotherapy, and group interventions in cancer patients in general (Fawzy et al., 1995). They concluded that there was evidence of benefit for all of these approaches, reporting that cancer patients may benefit from a range of psychological intervention programs, and suggesting specific interventions at different points along the cancer trajectory. Meyer and Mark conducted a meta-analysis of psychosocial interventions in adult cancer patients (Meyer and Mark, 1995). Effect sizes (treatment mean minus control mean divided by pooled standard deviation) of 0.19–0.28 for emotional adjustment, functional adjustment, and global measures were identified. These effect sizes were in the range considered clinically important, suggesting significant benefit from the interventions. Burke and Kissane prepared a review of psychosocial interventions provided to breast cancer patients by specialist providers (including both published and unpublished data), drawing fairly extensively from the general cancer literature (Burke and Kissane, 1998). They concluded that the benefits of psychosocial interventions in breast cancer were clearly established and recommended that such interventions be an “integral part of comprehensive medical care.” They presented a series of recommendations for future research and made more specific recommendations regarding integration of psychosocial interventions into the treatment setting. These were published in an overview paper outlining the need to challenge the health delivery system to improve and implement psychosocial and supportive care (Redman et al., 2003). Two targeted reviews concluded beneficial effects were present for relaxation and imagery interven-

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Meeting Psychosocial Needs of Women with Breast Cancer tions (Wallace, 1997) and for educational interventions in patients with cancer (Rimer et al., 1985). All of these reviews identified important areas for additional research. One recent review reached somewhat different conclusions (Newell et al., 2002). The authors of this review undertook an extensive review of psychological therapies in all types of cancer—they applied a series of rigorous methodological standards and retained only those reports that scored one-third or more of the total possible points. This resulted in exclusion of the majority of published studies. They also took a very conservative approach to evaluation of benefits, requiring that at least half of the outcome measures for a specific attribute (e.g., mood) yield significant results for the effect to be classified as significant. This assumes that all of the questionnaires were equally responsive to change, a situation that is not likely. They examined the short, medium, and long-term impact of interventions on a large number of outcomes including anxiety, depression, hostility, general or overall affect, stress or distress, general or overall functional ability or quality of life, coping or coping skills, vocational or domestic adjustment, interpersonal or social relationships, sexual or marital relationships, nausea, vomiting, pain, fatigue, overall physical symptoms, conditioned nausea, conditioned vomiting, survival, and immune outcomes. They did not distinguish the effects of interventions among different types of cancers. These authors concluded that “only tentative recommendations about the effectiveness of psychosocial therapies for improving cancer patients’ outcomes” were possible and recommended that future trials adhere to minimum methodological standards. Examples of their tentative recommendations included the use of music therapy to reduce anxiety and enhance overall affect, group therapy to enhance coping skills, counseling to enhance social or interpersonal relationships, and hypnosis to reduce conditioned nausea and vomiting. Further research was recommended into the benefits of these and other forms of therapy, including cognitive behavioral therapy, education, individual therapy, and interventions involving significant others. This review was thorough, but it did not focus on a specific type of cancer or a specific type of treatment, and its strict application of exacting methodologic criteria (some of which may not have been well suited to psychosocial research) places it at the conservative end of the spectrum of analyses and may have resulted in important effects of psychosocial interventions being missed or undervalued. Nevertheless, the Board realizes that attention needs to be paid to stronger research designs in future studies. Relatively few studies among those reviewed in this chapter may relate to a specific intervention, so that expanded research will be needed to strengthen evidence for a particular treatment.

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Meeting Psychosocial Needs of Women with Breast Cancer METHODOLOGICAL ISSUES There are a number of key methodological characteristics that are critical to the success of studies assessing the effectiveness of psychosocial interventions. Many of these methodological characteristics are similar in studies evaluating biomedical or psychosocial interventions. Others, notably those related to measurement and to standardization of the intervention, are unique challenges for researchers conducting psychosocial intervention trials. Study Design The gold standard design for studies that evaluate effectiveness of various interventions is the randomized controlled trial. The purpose of randomized allocation of patients is to avoid bias or confounding in the assignment of study treatments, thereby ensuring that patients in each arm of the study are as comparable as possible with respect to all characteristics except for the specific intervention(s) being studied. When baseline patient characteristics are potentially associated with effects of the intervention being studied (e.g., severity of anxiety or depression), methodological approaches to ensure balance between study arms (e.g., stratification) are recommended as part of the randomization process. This is particularly important in studies with a small sample size. Although randomized trials have been recognized as the gold standard since the mid-twentieth century, concerns have been raised that they may not be the most appropriate study design for evaluation of psychosocial interventions in cancer patients, in part because patient commitment to the intervention is deemed an important predictor of benefit from the intervention (Cunningham et al., 1998). It has been argued that if patients are willing to be randomized to a control arm, they are not as strongly committed to the intervention, and this will lead to an underestimation of the benefits of the intervention. Although this is possible, it is difficult to overcome self-selection biases (which may be powerful predictors of psychosocial outcomes) without using a randomized study design. It has also been argued that cancer patients may not be willing to accept randomization. This might occur not only in psychosocial trials but also in biomedical intervention trials. However, the success of the many randomized trials reviewed below argues against this as a major obstacle to successful conduct of randomized psychosocial intervention trials in breast cancer. When a randomized design is selected, it is important that the randomization not be compromised for logistical, or other, reasons. In the studies reviewed here, an example of compromised randomization occurred in an otherwise well conducted trial of the contribution of coaches to support groups for women with breast cancer when re-randomization was permit-

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Meeting Psychosocial Needs of Women with Breast Cancer ted in the two intervention arms (but not the control arm) if logistics of group meetings for the original randomized allocation were not convenient (Samarel et al., 1997). Another potential example occurred when assignment to a specialist nursing intervention versus control was according to the week women were admitted for surgery (weeks, not patients, were randomized) (Maguire et al., 1980). Theoretically, advance knowledge of whether the intervention was being administered in a given week could have influenced admission dates for individual women, leading to non-comparable study groups. The issue of selection of an appropriate control or comparison arm is also challenging in randomized psychosocial intervention trials. Although many researchers select a “no treatment” or “standard treatment” control group, others argue that the control group should receive a similar amount of attention to that received by the intervention group, so that beneficial effects of attention (as opposed to the “active” components of the intervention) are not falsely labeled as benefits of the intervention. Selection of a no-treatment (or standard treatment) control arm versus attention control arm should probably reflect the specific study question. If the purpose of the study is to evaluate the overall benefits of adding the psychosocial intervention being studied to routine clinical care, then a no-treatment (or standard treatment) control group would be most appropriate. If, however, researchers are attempting to delineate which aspects of the intervention (e.g., attention versus teaching of coping skills or a specific cognitive–behavioral therapeutic approach) are important determinants of benefit, then selection of an attention control group may be more appropriate. The selection of control conditions will become an even more challenging issue as the benefits of psychosocial interventions are increasingly accepted by the medical community and these interventions become standard care; these interventions will then become the control or comparison arm in future studies. To facilitate this selection of comparison arms, agreement will be necessary regarding which interventions are considered standard care. Some studies reviewed used “wait-list” controls. These controls were offered the study intervention after all study measurements were completed. Other studies passively offered educational materials to control subjects. Although these approaches may enhance acceptability of the study design to investigators, potential participants, and ethics committees alike, they are not truly no-treatment approaches and their use may tend to diminish treatment effects or, in the case of “wait-list” controls, make it difficult to examine long-term effects of interventions. These issues should be considered in both design and interpretation of trials. Finally, there are situations when non-randomized designs may be desirable. These include studies whose purpose is to develop and standardize an intervention, studies whose purpose is to demonstrate that an interven-

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Meeting Psychosocial Needs of Women with Breast Cancer tion is feasible and can be delivered in a standard fashion by more than one investigator, and pilot studies looking for early evidence of treatment effectiveness, before full commitment is made to an expensive, long-term randomized trial. Non-randomized designs may also be important for studies seeking to obtain descriptive information about patient experiences or information about change over time, as well as for studies examining prognostic effects of psychosocial status. Such non-randomized designs may also be used when randomization is difficult, such as in the evaluation of peer support, novel and/or alternative therapies (e.g., reiki, yoga or t’ai chi), or participation in Internet chat support rooms where access to the intervention may be available to controls outside of the study. However, when assessment of treatment effectiveness is the primary purpose of a study, a randomized design is optimal. Use of alternative designs may lead to biased or inaccurate results. Study Population Many published psychosocial intervention studies involve patients with more than one type of cancer or patients with the same type of cancer in various stages of their illness (for example, early stage curable and late stage metastatic). Although, in the long term, intervention studies may demonstrate that the effectiveness of psychosocial interventions does not vary across cancer type or cancer stage, this is not known a priori. More sharply focused trials include patients with one type of cancer, and, in most circumstances, one stage of cancer. In the reports reviewed here, only randomized trials that restricted study entry to breast cancer patients are included. Once the population of interest is identified (e.g., women with recently diagnosed breast cancer), the study population should be as representative of that population as possible. The characteristics of the women in the trials reported here are listed (Phase/Stage of Disease) in Appendix B. Although the review of Newell and colleagues (Newell et al., 2002) was critical of low reporting of randomization (about 25 percent) in the trials they reviewed, in the present case with the exceptions noted earlier, randomization appears acceptable. Furthermore, the populations offered the trials were drawn consecutively from, responded to advertisements or other solicitations to, or were identified through records of, patient groups similar to those that might be offered the intervention in routine practice, although this was not specifically stated in those words, with the caveat that many of the studied populations were in academic health centers. It would be interesting to study patients in a larger cross-section of settings. It is possible that attributes of the study population, such as age, medical treatment received, or baseline psychological characteristics will be predictors of effectiveness of psychosocial interventions. This was the case in a

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Meeting Psychosocial Needs of Women with Breast Cancer recent study in which the psychological benefits of supportive–expressive group therapy on mood were present in women who were distressed at study entry, but not in non-distressed women (Goodwin et al., 2001). Patient attributes that are potential predictors of benefit from the study intervention should be identified and their contribution to study outcomes carefully examined. Ideally, randomization should be stratified for these key baseline characteristics, as was discussed above. Finally, attempts are warranted to design research on larger sample sizes. About half the 31 trials reviewed in this chapter involved fewer than 100 subjects, in many cases 50 or fewer, weakening their power to provide strong evidence. The largest trial involved 312 women randomized to four arms and did not demonstrate lasting effects (Helgeson et al., 1999, 2000, 2001). The recent study from Australia by Kissane and colleagues randomized 303 women to group and relaxation versus relaxation alone. Positive findings of reduced anxiety and better function were found in this large cohort. Study Intervention Standardization of the study intervention is a particular challenge when the intervention is psychosocial in nature. As much as possible, investigators should use a well described, standardized therapy that has the potential to be delivered in routine practice by other trained and qualified practitioners who will be the end-users of the study results. When describing the intervention, the skills and the qualifications of the therapists must be included along with details of the intervention. Furthermore, it should be demonstrated that the therapy is delivered in a standardized fashion throughout the study. Ideally, investigators should provide evidence of compliance with the intervention as well as evidence of the competence of therapists delivering it. They should also report the dose/duration of exposure to the study intervention, and designs of longer duration should be considered for future studies. These issues are more straightforward when interventions are biomedical because investigators can simply describe the number of doses and number of milligrams of a drug that are administered. The challenge is much greater when the intervention is psychosocial. The interventions that were investigated in the reports reviewed here often involved more than one potentially active component. For example, group therapy, relaxation/self-hypnosis, and teaching of coping skills were included in a single intervention (Cunningham et al., 1998). When interventions have multiple components, it may be difficult for investigators to determine whether one, or all, of the components is responsible for the outcome. This is not a problem if it is the overall effectiveness of the intervention that is being investigated. However, if evidence of effectiveness of

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Meeting Psychosocial Needs of Women with Breast Cancer individual components is sought, it may be necessary to study each component separately. Study Measures Measurement of psychological outcomes is as exact a science as measuring biomedical outcomes, and requires the same attention to accuracy. There are many well validated, standardized instruments available that measure quality of life and psychosocial status. However, not all of these instruments measure attributes that are likely to be altered by specific study interventions (see Chapter 3 for a description of selected instruments). For example, an intervention targeting anxiety would not necessarily be expected to enhance role functioning. Furthermore, not all of the available instruments are sufficiently sensitive to detect clinically important change resulting from an intervention that is, in fact, efficacious. This was demonstrated in a recent randomized trial of supportive–expressive group therapy in metastatic breast cancer (Goodwin et al., 2001). Beneficial effects of the intervention on mood were readily detected using the Profile of Mood States. Similar benefits were not detected using the Emotional Functioning Subscale of the European Organization for Treatment and Research of Cancer (EORTC) QLQ-C30 (see Chapter 3). The selection of quality of life and psychosocial outcome measures in randomized trials in breast cancer patients, and the ability of these instruments to identify changes when various interventions are delivered, has recently been reviewed by Ganz and Goodwin (Ganz and Goodwin, 2003). It is recommended that investigators select, whenever possible, standardized, well validated, and well accepted outcome measures that are sensitive to clinically important change and that target attributes that are likely to be influenced by the intervention. For example, if the intervention is designed to reduce anxiety, then an instrument that specifically measures anxiety and is responsive to changes in anxiety should be used. As noted above, a general health-related quality of life (HRQOL) instrument that measures emotional functioning in a general way with a small number of items and limited response categories may miss important changes in mood that can be detected with other instruments. Thus, use of these general HRQOL instruments as sole outcome measures in psychosocial intervention studies is not recommended. At times, it will be necessary for investigators to develop new instruments or new modules of existing instruments in order to ensure they are targeting key attributes. When this is the case, care should be taken to validate these new measures before they are used as study outcomes. However, wholesale development of new instruments when acceptable instruments already exist is not recommended because it reduces the ability to compare results across studies.

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Meeting Psychosocial Needs of Women with Breast Cancer An additional challenge in psychosocial intervention research relates to compliance with study measurements. A balance must be reached between patient burden and comprehensiveness. Every effort should be made to encourage patients to comply with study measurements. The problem of missing data points has been a troublesome issue in psychosocial research. This is particularly challenging when patients are seriously ill, or undergoing complex medical treatments, or when multiple outcome measures are being used. Blinding should be used in outcome assessments to the extent possible, given the study design. When outcomes are self-reported, patients should be unaware of the specific study hypothesis (if possible), and research staff who score the questionnaires should be unaware of subjects’ randomization allocation. When outcomes are interview-based, interviewers should be blinded to randomization allocation. Finally, cost and feasibility assessments to allow the possible balancing of benefits against costs of psychosocial interventions or programs should be included insofar as is possible and consistent with the abilities of the investigators, time and money resources available, and capacities of the settings. It is recognized that this is easier said than done, and that with the exception of an occasional study or mention in reports is rarely accomplished (Koocher and Pollin, 2001; Simpson et al., 2001). Outcome/Analysis Each randomized trial should have a clearly stated hypothesis and a clearly stated primary outcome; sample size calculations and statistical analyses should reflect this primary study question. The description of the primary outcome should include a description of the specific questionnaire and/or questionnaire item/scale as well as the specific time-point(s) in the study that will be used to define this outcome. If more than one primary study outcome (or time-point) is selected, allowances must be made for multiple testing in statistical analysis and sample size calculations. At times, the issue of multiple time-points can be overcome using statistical methods, such as repeated measures analysis of variance or slopes analysis, that incorporate measurements performed at multiple times into a single statistical analysis. Thus, although studies may use multiple instruments administered at multiple time-points with a plan for multiple approaches to analysis, the primary endpoint, time-point, and analytic approach must be stated a priori, and the sample size and significance cut-points must reflect these decisions. Other endpoints and/or analyses should then be viewed as secondary or hypothesis-generating. This will overcome the common criticism of psychosocial intervention studies that use of multiple outcomes, all of which are treated equally in the analysis, leads to multiple, and at times conflicting,

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Meeting Psychosocial Needs of Women with Breast Cancer study results with a high experiment-wide type-1 error (the probability of incorrectly accepting a study hypothesis that is not true) (Newell et al., 2002). In evaluating outcomes, it might also be useful to consider whether the length of follow-up should be related to the length of time that the treatment’s effect is expected to be needed. For example, if the intervention being tested is intended to deal with a current problem, like getting through physical treatments like surgery, radiation, or chemotherapy, a long follow-up may not be required and could lead to an erroneous conclusion that the treatment was not effective because its effects did not last until the final follow-up. Also, since trials of psychosocial interventions evaluated here are often applied to the whole population of women with breast cancer, they may include some women who would not have, or would not develop, psychosocial problems. This might dilute results and explain lack of effect in some trials. The majority of the published psychosocial intervention studies in breast cancer reviewed here have selected psychosocial outcomes as their primary outcome measure, but some have also included biomedical outcomes, notably survival, treatment response, and immune factors. As with psychosocial outcomes, when biomedical outcomes are being studied, the primary outcome must be identified a priori. The only exceptions to this rigorous approach occur in hypotheses generating studies such as pilot studies, or in studies designed to standardize interventions. Descriptive qualitative–analytic studies of cancer patients’ narratives, or correlative studies examining inter-relationships of psychosocial variables that are designed to generate, rather than confirm, hypotheses are also excluded. Nonetheless, such studies provide important hypotheses that are generated and subjected to confirmation in future trials. REVIEW OF THE LITERATURE Methods Literature searches were conducted using computerized databases (MedLine, Cancer Lit) between March 2002 and August 2002 using the following headings: breast cancer and psychological intervention breast cancer and psychosocial intervention breast cancer and relaxation intervention breast cancer and hypnosis intervention breast cancer and group therapy intervention breast cancer and individual therapy intervention breast cancer and psychotherapy intervention

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Meeting Psychosocial Needs of Women with Breast Cancer Summary of Effectiveness of Psychosocial Interventions According to Type of Intervention As was discussed in the preceding section, many of the published reports have identified psychological benefits of a variety of psychosocial interventions. These studies are reorganized in Appendix B, Table B-3 into three groups. The first group involves studies that primarily evaluated relaxation and/or imagery, whether the approach was individual or group based. The second category of interventions involved therapy delivered in a group setting; the specific type of therapy varied across studies. It included cognitive–behavioral therapy, structured group therapy, supportive–expressive group therapy, education with or without peer discussion, and mind– body–spirit groups. In the final section of Table B-3, studies of interventions in individuals are listed. These individual interventions were delivered in person or by telephone. Interventions included psychological assessment, telephone screening, cognitive–behavioral counseling, and several of these studies evaluated a variety of nursing interventions, focusing mainly on women with early stage breast cancer. Consideration was given to grouping studies by type of therapy evaluated (e.g., supportive, cognitive–behavioral). However, many of the interventions included components of more than one type of therapy (e.g., Cunningham), and some could not be easily classified into a specific therapeutic approach (e.g., telephone screening). Furthermore, the classification of interventions into group or individual approaches reflects current interest in group approaches for women with breast cancer. Studies involving couples counseling or partners of breast cancer patients are not included in these tables (Bultz et al., 2000; Christensen, 1983). Studies evaluating relaxation with or without imagery appear in the first section of Table B-3. Studies in early breast cancer are listed first (Arathuzik, 1994; Bridge et al., 1988; Kolcaba and Fox, 1999; Molassiotis et al., 2002; Richardson et al., 1997; Walker et al., 1999). With a single exception (Arathuzik, 1994), all of these studies provided evidence of effectiveness of the intervention, including improvements in mood, relaxation, comfort, overall quality of life, acceptance of death, enhanced coping, as well as reduced nausea and vomiting. The effective studies were all conducted in early phase breast cancer, the majority during initial treatment. Most of these interventions were short-term (6 days to 6 months), and the majority involved the use of relaxation audiotapes. One study utilized a group intervention (that study is also listed in the group intervention section of Table B-3) (Richardson et al., 1997). Taken together, these studies provide evidence of the effectiveness of relaxation with or without imagery in relieving psychologic distress or side effects of treatment (including nausea) in the early phases of breast cancer, effects that were present during active treatment with radiation and/or chemotherapy. The failure of

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Meeting Psychosocial Needs of Women with Breast Cancer Arathuzik to identify significant effects may reflect the fact that the intervention was delivered in one session, that the study involved only 24 women (the power may have been inadequate to identify significant effects), or that the study was conducted in the setting of metastatic breast cancer, a setting in which a longer intervention may be needed (Arathuzik, 1994). Because of these limitations, further research would be needed to clarify the effectiveness of relaxation as a sole modality or combined with brief (single session) cognitive–behavioral therapy in metastatic breast cancer. The second section of Table B-3 lists studies that evaluated a variety of group interventions. Studies of supportive therapy (including a study that compared supportive therapy to mind–body–spirit group therapy) are listed first, followed by those of supportive–expressive therapy, and then those that evaluated interventions having cognitive–behavioral therapy as a component (studies in early breast cancer are listed first in each grouping). These studies are roughly evenly split between early stage (seven studies) and metastatic (five studies) breast cancer. Four of these studies included cognitive– behavioral therapy either as the sole treatment modality, or as a major treatment modality. Three utilized a manual-based form of therapy: supportive–expressive therapy, combined with relaxation. One evaluated the benefits of therapist facilitated peer discussion groups, comparing them to education alone or to education combined with therapist-facilitated peer discussion, and one investigated a mind–body–spirit (CAM) group intervention. The interventions in early stage breast cancer tended to be shorter (6 to 12 weeks) than those conducted in metastatic breast cancer (5 months to end of life). Despite the differences among these studies, the majority demonstrated important psychosocial benefits, although some of the studies conducted in early stage disease evaluated psychological outcomes for only a brief period of time (6 weeks) (Richardson et al., 1997). The benefits reported in these studies included improved mood, enhanced coping, reduced phobias, reduced traumatic stress symptoms, enhanced vitality, social and role functioning, reduced severity of psychiatric symptoms, enhanced quality of life, and enhanced spiritual integration. One study reported prolongation of survival (this is discussed in greater detail in the next section) (Spiegel et al., 1989). In at least one study beneficial effects of the intervention (an educational intervention) dissipated over time (Helgeson et al., 2001). In contrast to these largely positive findings, there were some studies that did not identify significant overall effects. For example, Edmonds et al., studying 66 patients evaluating supportive plus cognitive–behavioral group therapy versus home cognitive–behavioral study, reported “little psychometric effects” although there were some minor changes in coping style (Edmonds et al., 1999). The fact that the control group in this study also received interventions such as a home cognitive–behavioral study package and supportive

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Meeting Psychosocial Needs of Women with Breast Cancer telephone calls may have contributed to these negative results. Antoni et al. also failed to identify overall effects for a structured cognitive–behavioral group intervention, although they did find some beneficial effects in subgroups (Antoni et al., 2001). In evaluating Antoni’s results, it must be noted that only the 73 percent of randomized women that completed all study assessments were included in the analysis; this could have introduced bias and made it difficult to identify important effects of the intervention. Two studies evaluated the benefits of facilitated peer discussion or the use of coaches in support groups. Samarel, evaluating the addition of coaches to a structured support group, found higher quality relationships in the short-term when coaches were incorporated into the groups; however, these effects did not last beyond 8 weeks (Samarel and Fawcett, 1992; Samarel et al., 1993, 1997). In this study, some patients were re-randomized if their initial randomization resulted in an allocation that posed logistical difficulties. Because of this, these results must be interpreted with caution. Helgeson is the only investigator to have evaluated a facilitated peer discussion group in women with breast cancer (Helgeson et al., 1999, 2000, 2001). No benefits of facilitated peer discussion were identified in this large study in which women were followed for up to 4 years after randomization. Firm conclusions about facilitated peer discussion groups will require more than a single study. Targ and Levine demonstrate comparability of psychoeducational group support to a complex CAM group support that addressed the mind– body–spirit continuum for most key psychosocial and HRQOL outcomes (Targ and Levine, 2002). Enhanced satisfaction and spiritual integration were reported in those who participated in the CAM group. Overall, there was little evidence that the type of group therapy used led to different therapeutic effects; psychological benefits of various types were reported in cognitive–behavioral group interventions, supportive–expressive group interventions, and other interventions. There have been no head-to-head comparisons of the two most commonly utilized types of support groups: cognitive–behavioral and supportive–expressive. Such a comparison might lead to an enhanced understanding of the relative benefits of each type of intervention. On the basis of evidence currently available, selection of one type of intervention could probably be based on therapist and/or patient preference. Finally, individual interventions have been listed in the third section of Table B-3. All of these were conducted in early breast cancer. The interventions evaluated in these studies were quite variable, including psychological interviews, telephone screening, individual cognitive–behavioral therapy, and problem skills training as well as a variety of nursing interventions. These nursing interventions yielded somewhat mixed results. In a very early study, Maguire et al. showed that nurse specialist counseling increased rec-

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Meeting Psychosocial Needs of Women with Breast Cancer ognition of the need for psychiatric referral and that subsequent psychiatric intervention reduced psychiatric morbidity (Maguire et al., 1980, 1983). McArdle et al. identified important psychosocial and quality of life benefits for support from a breast cancer nurse compared to support from a voluntary organization of usual care (McArdle et al., 1996). Similarly, Wengström et al. reported fewer distress reactions and a stronger motivation to be emotionally involved in women who received a nursing intervention based on Orem’s model for self-care (Walker et al., 1999; Wengström et al., 1999, 2001). Ritz et al., evaluating advanced practice nursing interventions, identified reduced uncertainty, as well as beneficial subgroup effects on mood in those without a family history of breast cancer (Ritz et al., 2000). Cimprich reported beneficial effects of an unusual intervention designed to restore attentional capacity (Cimprich, 1993). In contrast, Sandgren et al. reported no overall beneficial effects of telephone-based cognitive–behavioral therapy (Sandgren et al., 2000). Similarly, Allen et al., evaluating problem-solving skills training (two sessions in person, four by telephone), identified no overall effects, although subgroup analysis suggested that there may be some benefit in women with good problem-solving skills at baseline (Allen et al., 2002). Finally, Lev et al., evaluating nurse counseling supplemented with videotape and a self-care booklet, reported “small to large effect sizes” for quality of life outcomes and psychiatric symptoms but did not perform any significance testing in their small study (Lev et al., 2001). A single study of individual cognitive–behavioral counseling identified improved depression and quality of life in women receiving the intervention, similar to the findings reported for group cognitive–behavioral therapy (Marchioro et al., 1996). Similar effects were noted for a brief (one session) psychological interview, with or without a subsequent brief psychotherapy session (Burton et al., 1995). Maunsell’s study of telephone screening for psychologic distress with referral of distressed patients to a social worker did not lead to any identifiable psychological benefits (Maunsell et al., 1996). Use of a health-care professional to provide screening (as opposed to a research assistant) and closer coordination of referrals to a therapist (rather than forwarding the patient’s name to a social worker who attempted to contact the patient by telephone) may have led to better screening and counseling and different results. Further research in this area is needed. Taken together, these studies of individual interventions have identified some important psychological benefits; however, their results are not as consistent as those of relaxation/imagery interventions or group interventions. It is probably too early to make comparisons across types of interventions, particularly since there have been no head-to-head comparisons of individual versus group interventions. It is notable that trials of individual interventions have been conducted in early stage breast cancer only, that

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Meeting Psychosocial Needs of Women with Breast Cancer some of the interventions have been extremely brief, and that the variety of the interventions studied has been much broader than the variety of interventions used in the group setting. Furthermore, although many reports in the metastatic setting in particular have examined long-term benefits, some, especially those in early stage breast cancer, have examined extremely short-term benefits (Arathuzik, 1994; Goodwin et al., 2001; Molassiotis et al., 2002; Richardson et al., 1997; Spiegel et al., 1989; Walker et al., 1999). In general, there is fairly good support for a short to intermediate term benefit for many group and individual interventions in early breast cancer (up to six months). However, the long-term benefits of interventions (apart from group interventions in the metastatic setting) have not been adequately evaluated. Review of Selected Studies Using Non-Randomized Designs There is an extensive literature describing a variety of psychosocial interventions in cancer using non-randomized designs. Some of these studies focus on breast cancer patients. Others, including some that used randomized designs, involve patients with many different types of cancer. These studies are too numerous to review in detail; a small selection that highlights key points will be reviewed here. Devine and Westlake have published an excellent meta-analysis2 of over 100 studies of psycho-educational care in cancer patients (Devine and Westlake, 1995). These studies were conducted in a variety of settings, in patients with a variety of cancers, and they evaluated a range of interventions. The majority of the studies reviewed were conducted in the United States, and the most common setting for the intervention was the outpatient treatment department. Some of the interventions involved education only; others included muscle relaxation, guided imagery, and other behavioral interventions. Statistically significant benefits were found for anxiety, depression, overall mood, nausea, vomiting, pain, and knowledge in the meta-analysis. It was concluded that psycho-educational care was of benefit to adults with cancer, but that it was difficult to differentiate the effectiveness of various types of psycho-educational care. The results of this meta-analysis are consistent with the findings of Helgeson et al. reported above in which a psycho-educational group intervention administered to women with breast cancer was found to be effective for a variety of psychosocial outcomes (Helgeson et al., 1999, 2000, 2001). They are also consistent with a recent non-randomized study by Sepucha et al. in which breast cancer patients were assigned either to a 2   The term “meta-analysis” refers to the statistical analysis of the results from many individual studies for the purpose of integrating the findings.

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Meeting Psychosocial Needs of Women with Breast Cancer control intervention (productive listening) in which a researcher listened to and prompted patients to reflect on their experiences communicating with physicians or to an experimental intervention (consultation planning) in which a researcher actively assisted patients in preparing for an upcoming consultation, generating a printed agenda, and developing techniques to improve communication with their physicians (Sepucha et al., 2002). Patients who received the experimental intervention reported significantly higher satisfaction, a sentiment that was echoed by the patients’ physicians, suggesting that psycho-educational interventions and/or interventions that prepare patients for consultations with their physicians in a structured fashion may result in psychological benefit. A series of studies conducted by Hosaka et al. in Japan evaluated a structured intervention that included psycho-education, problem-solving, psychological support, relaxation training, and guided imagery (Hosaka et al., 2001a, 2001b, 2000a, 2000b, 2000c). Using non-randomized before-after designs, these investigators first demonstrated psychological benefits of a 5 week intervention in women with node-negative breast cancer who did not have adjustment disorders but not in those with positive nodes or adjustment disorders. They later added three sessions at two monthly intervals and were able to show persistent benefit in all women regardless of nodal status or presence of an adjustment disorder. Additionally, they identified a series of psychological attributes predictive of improvement (good relationship with doctors, family support/understanding, no co-morbid adjustment disorders). Although these results should be confirmed in a randomized trial, this pilot work suggested characteristics of women who needed a longer intervention and the efficacy of a longer intervention. There are a number of interventions of potential psychosocial value that have not undergone adequate scrutiny in a randomized trial. Some patients are interested in these interventions, and some are used with increasingly frequency; for example, Internet chat groups, art therapy, music therapy, yoga, reflexology, and t’ai chi. Evidence supporting the benefits of these interventions is lacking. Targ and Levine (2002) evaluated a multi-factorial mind–body–spirit group intervention and suggested that these alternative therapy interventions will be well received by women with breast cancer and that they may provide psychosocial benefit similar to more traditional psychosocial interventions. Haun and colleagues reported results of a non-randomized comparison of women awaiting breast biopsy who were exposed to either a 20 minute music-based intervention or to usual care (Haun et al., 2001). The music intervention involved a selection of “new age music” from which participants chose a 20-minute segment which they listened to via headphones. Women who received the intervention had a lower level of anxiety (measured using the State Trait Anxiety Inventory) and a lower respiratory rate. Similar information regarding other comple-

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Meeting Psychosocial Needs of Women with Breast Cancer mentary interventions is likely to be forthcoming. Formal evaluation of the benefit, both in the long-term and short-term, of some of these interventions will be of interest. Ashbury et al. evaluated a Canadian Cancer Society post-mastectomy peer visitor program, Reach to Recovery (Ashbury et al., 1998). They reported that patients were generally satisfied with the program and presented evidence of enhanced quality of life for participants. This non-randomized study suggests a beneficial effect of peer support shortly after breast cancer diagnosis. Finally, there is a growing number of reports of benefit from a range of psychological interventions in breast cancer. In this literature, either the intervention or the subject population is novel. For example, Spiegel et al. have evaluated supportive–expressive group therapy in early stage breast cancer using a pre-, post-test design; they indicate that mood is enhanced, anxiety and depression are reduced, and traumatic stress symptoms reduced over a 6 month period (Spiegel et al., 1999). Because the study design was pre- and post-test and not randomized, it cannot be concluded that these benefits arose from the supportive–expressive group therapy intervention and not from spontaneous improvement as women adapted to their diagnosis. Similar benefits were seen in the metastatic setting, suggesting that at least some of these benefits might have arisen from the group intervention. Donnelly et al. carried out a pilot study of interpersonal psychotherapy administered by telephone to cancer patients receiving high dose chemotherapy and their partners (Donnelly et al., 2000). They reported the feasibility of the intervention and that participants were satisfied with the intervention. Further exploration of this approach could be useful for a number of reasons. It uses a therapeutic approach that has not been evaluated in a randomized trial in breast cancer patients (interpersonal psychotherapy), the intervention is telephone-based (some of the randomized trials of telephone-based interventions have not been successful in breast cancer patients), and it intervenes not only with breast cancer patients but also with partners—a group that has not received as much attention in the randomized trials setting. This brief, and selective, presentation of findings outside of the clinical trials setting is not intended to be comprehensive. Instead, it is intended to demonstrate that there is currently a broad spectrum of interesting and potentially useful research that is looking at a spectrum of novel interventions. Additional research is recommended to address research gaps, to evaluate the generalizability of research findings across gender and cancer type, and to examine the translation of research findings into community practice. The Board’s priorities for future research are described in Chapter 8.

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Meeting Psychosocial Needs of Women with Breast Cancer SUMMARY The results of 31 randomized trials in women with breast cancer and two meta-analyses, supported by observations in non-randomized studies, provide evidence of beneficial effects of a range of psychosocial interventions in both early and metastatic breast cancer. Notably, there is evidence for the benefit of relaxation/hypnosis/imagery interventions in early stage breast cancer, for group interventions in both early and metastatic breast cancer, and for individual interventions, primarily in the early setting. Although it needs strengthening, this evidence supports the conclusion that psychosocial interventions can be expected to reduce psychiatric symptoms and improve quality of life in routine clinical care of breast cancer. REFERENCES Agency for Healthcare Research and Quality. 2002. Management of cancer symptoms: Pain, depression, and fatigue: Summary. Evidence Report/Technology Assessment (61):1–9. Allen SM, Shah AC, Nezu AM, et al. 2002. A problem-solving approach to stress reduction among younger women with breast carcinoma: A randomized controlled trial. Cancer 94(12):3089–3100. Antoni MH, Lehman JM, Kilbourn KM, et al. 2001. Cognitive–behavioral stress management intervention decreases the prevalence of depression and enhances benefit finding among women under treatment for early-stage breast cancer. Health Psychol 20(1):20–32. Arathuzik D. 1994. Effects of cognitive–behavioral strategies on pain in cancer patients. Cancer Nurs 17(3):207–214. Ashbury FD, Cameron C, Mercer SL, Fitch M, Nielsen E. 1998. One-on-one peer support and quality of life for breast cancer patients. Patient Educ Couns 35(2):89–100. Bridge LR, Benson P, Pietroni PC, Priest RG. 1988. Relaxation and imagery in the treatment of breast cancer. Br Med J 297(6657):1169–1172. Bultz BD, Speca M, Brasher PM, Geggie PH, Page SA. 2000. A randomized controlled trial of a brief psychoeducational support group for partners of early stage breast cancer patients. Psycho-Oncology 9(4):303–313. Burke S, Kissane DW. 1998. Psychosocial impact of breast cancer: A review of interventions by specialist providers: A summary of the literature 1976–1996. NHMRC National Breast Cancer Center, NSW, Australia. [Online]. Available http://www.nbcc.org.au/pages/info/resource/nbccpubs/psych/interv/contents.htm [accessed October 23, 2003]. Burton MV, Parker RW, Farrell A, Bailey D, Conneely J, Booth S, Elcombe S. 1995. A randomized controlled trial of preoperative psychological preparation for mastectomy. Psycho-Oncology 14:1–19. Christensen DL. 1983. Postmastectomy couple counseling: An outcome study of a structured treatment protocol. J Sex and Marital Ther 9:266–275. Cimprich B. 1993. Development of an intervention to restore attention in cancer patients. Cancer Nurs 16(2):83–92. Classen C, Butler LD, Koopman C, et al. 2001. Supportive–expressive group therapy and distress in patients with metastatic breast cancer: A randomized clinical intervention trial. Arch Gen Psychiatry 58(5):494–501. Cunningham AJ, Edmonds CV, Jenkins GP, Pollack H, Lockwood GA, Warr D. 1998. A randomized controlled trial of the effects of group psychological therapy on survival in women with metastatic breast cancer. Psycho-Oncology 7(6):508–517.

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