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Impact of a Peer-Delivered Telephone Intervention for Women Experiencing a Breast Cancer Recurrence

Carolyn Cook Gotay, Carol M. Moinpour, Joseph M. Unger, Caroline S. Jiang, Dorothy Coleman, Silvana Martino, Beverly J. Parker, James D. Bearden, Shaker Dakhil, Howard M. Gross, Scott Lippman, Kathy S. Albain

From the Cancer Research Center of Hawaii, Honolulu, HI; Southwest Oncology Group Statistical Center, Seattle, WA; John Wayne Cancer Institute, Santa Monica, CA; Y-ME National Breast Cancer Organization, Chicago; Loyola University Medical Center, Maywood, IL; Upstate Carolina Community Clinical Oncology Program (CCOP), Spartanburg, SC; Wichita CCOP, Wichita, KS; Dayton CCOP, Dayton, OH; and the M.D. Anderson Cancer Center, Houston, TX

Address reprint requests to Carolyn Cook Gotay, PhD, Cancer Research Center of Hawaii, 1960 East-West Drive, Biomed C-105, Honolulu, HI 96822; e-mail: cgotay{at}crch.hawaii.edu

	ABSTRACT

TOP ABSTRACT INTRODUCTION PATIENTS AND METHODS RESULTS DISCUSSION AUTHORS' DISCLOSURES OF... AUTHOR CONTRIBUTIONS Appendix REFERENCES

 
Purpose A first breast cancer recurrence creates considerable distress, yet few psychosocial interventions directed at this population have been reported. The Southwest Oncology Group conducted a phase III randomized trial to evaluate the effectiveness of a brief telephone intervention.

Patients and Methods Three hundred five women experiencing a first recurrence of breast cancer were randomly assigned to standard care or intervention. The intervention consisted of four to eight telephone calls delivered over a 1-month period. The calls were conducted by trained peer counselors at a breast cancer advocacy organization, the Y-ME National Breast Cancer Organization, and followed a standard curriculum. Psychosocial distress (Cancer Rehabilitation Evaluation System–Short Form [CARES-SF]) and depressive symptoms (Center for Epidemiologic Studies Depression Scale [CES-D]) outcomes were assessed at baseline and 3 and 6 months. The 3-month assessment was the primary end point and is the focus of this article.

Results Analysis revealed no differences in distress or depressive symptoms at 3 months between the intervention and control groups; at 3 months, 70% of control patients and 66% of intervention patients reported psychosocial distress, and 40% of control patients and 47% of intervention patients exhibited depressive symptoms.

Conclusion Telephone peer counseling did not lead to better psychosocial outcomes. The persistent distress in these women supports the urgent need for the development and testing of more intensive or different supportive interventions for this group of patients.

	INTRODUCTION

TOP ABSTRACT INTRODUCTION PATIENTS AND METHODS RESULTS DISCUSSION AUTHORS' DISCLOSURES OF... AUTHOR CONTRIBUTIONS Appendix REFERENCES

 
Breast cancer's return is one of survivors' greatest fears.^1-5 When a woman experiences recurrence, numerous negative consequences ensue.^6-10 Many women report that recurrence is more upsetting than their initial disease.¹¹ However, few psychosocial interventions address the heightened concerns during recurrent breast cancer.^6,9,12

Psychosocial support provided by telephone may meet these needs. Supportive telephone interventions are well established in health care,^13-17 although breast cancer–specific reports have yielded equivocal results.^18-20 Recent results of a multicenter randomized trial for early-stage breast cancer patients completing primary treatment (N = 304), in which patients received either standard care or a 1-year telephone intervention delivered by experienced counselors, showed that both intervention and control groups demonstrated significant improvements in depressive symptoms and distress over time, with some analyses favoring the intervention group (A. Marcus, personal communication, February 2007).

Another commonly used intervention is peer support: assistance cancer survivors provide to other patients. This approach has long been part of cancer care, with numerous benefits shown for breast cancer survivors.^22-26 However, whether peer support is effective when provided by telephone is unknown.

The diagnosis of breast cancer recurrence provides a compelling setting to examine the impact of peer-delivered telephone support. The Southwest Oncology Group (SWOG) conducted a randomized intervention trial to evaluate the effectiveness of a brief telephone intervention. Telephone counselors who had experienced a breast cancer recurrence themselves and were based at the Y-ME National Breast Cancer Organization (Y-ME) delivered the intervention. Psychosocial predictors of well-being that are linked with breast cancer patient outcomes were also examined: social support,²⁷ optimism/pessimism,²⁸ perception of surprisingness of the recurrence,⁶ and sense of coherence.²⁹

	PATIENTS AND METHODS

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Eligibility criteria included first recurrence after definitive surgical treatment for women with stage I, II, or IIIa breast cancer, with or without other therapies; informed of recurrence within the last 56 days; no current psychiatric diagnosis affecting participation; ability to read and understand English; baseline questionnaire completion; and written informed consent. A first recurrence was defined as any distant metastatic site, and/or chest wall or nodal recurrence. Ipsilateral breast tumor recurrence after lumpectomy and isolated contralateral new primary breast cancers were excluded. All study procedures commenced after approval by a local human investigations committee and in accordance with an assurance filed with and approved by the Department of Health and Human Services.

General Study Procedures
SWOG nurses, clinical research associates (CRAs), or physicians recruited patients. Before random assignment, patients completed study questionnaires. Random assignment was performed through the SWOG Web Registration Program, which automatically conveys treatment assignment, through a call to the SWOG Statistical Center. Assignment to the control group (CG) or telephone intervention group (TG) was dynamically balanced by the stratification factors (age, recurrence site, and time since diagnosis; Table 1) according to Pocock and Simon's method.³⁰ Contact information for TG patients was faxed to Y-ME, and a counselor initiated patient contact within several days. At 3 and 6 months, the nurse or CRA mailed questionnaires to all patients; TG patients also received an intervention evaluation form. Patients went off study at 6 months, and CG patients were mailed materials TG patients had received previously.

A standardized intervention protocol based on a pilot study in 12 institutions (S9632) was used (Table 2.). Patients received four to eight counseling/information sessions delivered by telephone at weekly intervals, with one to two calls per week. The number of sessions was based on a literature review of brief telephone interventions.¹⁶ The intervention content reflected the most common domains in multidimensional models of quality of life³¹ and the primary concerns expressed by breast cancer patients.³² After the first session, patients were sent a standardized packet of information, primarily National Cancer Institute (NCI) pamphlets.

Emotional well-being. Emotional well-being was measured by the Cancer Rehabilitation Evaluation System–Short Form (CARES-SF) Psychosocial Scale, using a validated cutoff score of 0.615 or more³³; scores at or above this cutoff reflect at-risk status for emotional problems. The CARES-SF yields both a total score and five subscales.^34,35 This questionnaire has been shown to be valid, reliable,^33,36-38 and responsive to change.³⁹

Depressive symptoms. Depressive symptoms were assessed with the Center for Epidemiological Studies-Depression (CES-D), using a validated cutoff score of 16 or higher; patients with scores above this cutoff are at risk for depression.^40-43 The CES-D has been extensively used in community and patient populations, including cancer patients.^40-43

Baseline Psychosocial Predictors for Emotional Well-Being and Depressive Symptoms
Social support. Reynolds et al's four-item social support scale, found to predict breast cancer survival,²⁷ assessed instrumental and emotional dimensions of social ties.

Optimism/pessimism. Optimism/pessimism was measured with the total score on the well-validated Life Orientation Test.^28,44 The coefficient alpha () for this sample was 0.81.

Surprisingness of the recurrence. A single three-point question found to correlate with recurrence distress⁶ assessed the patient's perception of how surprised she was about the breast cancer recurrence: completely surprised, knew it would happen, not at all surprised.

Sense of coherence. The extent to which the patient viewed her life as comprehensible, manageable, and meaningful was measured by the total score on the short form of Antonovsky's well-validated Sense of Coherence scale.^29,45 The coefficient for this sample was 0.84.

Support services. All patients completed a support services form regarding their use of community services and other assistance (eg, support groups, counseling) during the previous 6 months at baseline and 3 and 6 months.

Telephone counseling evaluation form. At 3 and 6 months, TG patients rated satisfaction with the intervention and suggestions for improvements. Satisfaction scores were coded as high (3 or 4) or low (1 or 2).

Statistical Considerations
The planned sample size was 300 eligible patients (150 per arm) to yield 255 study participants with completed 3-month questionnaires. The estimated 3-month questionnaire completion rate was based on prior SWOG rates in excess of 85%.

Primary outcomes. Two primary end points were evaluated at 3 months: cutoff scores for the CARES-SF psychosocial summary score and CES-D score. The 3-month assessments must have been completed within 1.5 months of the 3-month time point. Patients were coded 1 if they had psychosocial distress or depressive symptoms, and 0 otherwise. Logistic regression for each scale was performed, adjusting for the protocol-specified stratification factors (age, recurrence site, and time since diagnosis). To account for baseline status, baseline CARES-SF or CES-D score, respectively, were included as covariates in every model, including univariate analyses of potential predictive factors.

Only patients with both baseline and 3-month measures were included in the analysis of the primary end point. Covariate data for the primary models were complete as required for stratification. An level of 0.025 was used to adjust for the two planned primary analyses. This design has at least 90% power to detect a difference of 21% between the control and intervention arms in psychosocial distress or depressive symptoms. Alpha, power, and group difference sizes were specified a priori.

Secondary outcomes. Secondary analyses examined associations between baseline predictors and 3-month scores: CARES-SF psychosocial summary, CES-D, CARES-SF physical functioning, and CARES-SF global, using logistic regression. Patients were coded 1 if they recorded any limitations on physical functioning or global functioning, respectively, and 0 otherwise. Codings for the baseline predictors are indicated in Table 4. Patients with any missing observations for any variables in the respective model were automatically excluded by the model. No imputation of missing variables was performed. We also conducted the same analyses controlling for treatment assignment.

	RESULTS

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Patient Characteristics
Three hundred twenty-eight patients were registered (July 1998 through November 2002), with 23 ineligible, primarily (n = 16) because of insufficient baseline documentation. Table 1 summarizes characteristics of the 305 eligible patients: 153 patients in the CG arm and 152 patients in the TG. The arms were generally well-balanced for prognostic factors, with two statistically significant exceptions: more TG patients received chemotherapy, whereas more CG patients received hormone therapy for recurrence. Statistically significantly more patients in the CG progressed (progression also includes death) during the 6 months on study.

Form Submission Rates
After the required baseline submission, subsequent submission rates for the CARES-SF, the CES-D, and the support services form were, respectively, 87%, 88%, and 89% (3 months) and 78%, 80%, and 79% (6 months). The most common reason for missing forms at 3 months was patient refusal; at 6 months, patient refusal and death. All baseline variables shown in Table 2 were analyzed in responders versus nonresponders at 3 months, and none predicted response (P > .05 in all cases). The high 3-month submission rates and successful enrollment of 305 eligible patients achieved full power to meet study objectives.

Telephone Counseling Intervention
Of 152 eligible TG patients, 122 (80%) completed the intervention. Thirty patients did not complete the intervention: 15 patients refused, eight could not be reached, five progressed, and two died. Table 2 shows the number, duration, and content of calls. As anticipated, most patients received four calls, although there was considerable variation in number of calls, and total minutes and days delivering the intervention. Seventy percent of patients discussed all four module topics with their counselor.

Primary Outcomes
Table 3 shows findings for the primary 3-month end point. A total of 246 eligible patients had complete baseline and 3-month data for the CARES-SF psychosocial summary measure. Seventy percent of control patients and 66% of intervention patients exhibited psychosocial distress. In the multivariate model, there was no evidence that the intervention differentially impacted the outcome (odds ratio [OR] = 0.80; 95% CI, 0.41 to 1.54; P = .50).

An additional factor indicating the patient's progression/death status was included as an adjustment variable in each of the two primary logistic regression models. This adjustment did not substantially modify the association between treatment assignment and either the psychosocial score (OR = 0.88; 95% CI, 0.45 to 1.73; P = .71) or depressive symptoms (OR = 1.45; 95% CI, 0.83 to 2.53; P = .19). We also conducted regression analyses using psychosocial status and depressive symptoms as continuous, rather than categoric, variables. No intervention effects were found in these analyses.

Secondary Outcomes
Table 4 reports univariate analyses of patient sociodemographic, clinical, and psychosocial predictors on the 3-month CARES-SF psychosocial, physical, and global scores and on the CES-D were performed. Less psychosocial distress was associated with high coherence and high optimism, whereas more distress was associated with primary chemotherapy. Less depressive symptomatology was associated with high coherence, whereas more depressive symptoms were associated with opioid pain treatment and primary chemotherapy. High physical scores were associated with receiving primary or recurrence chemotherapy, being married, and receiving opioid pain treatment. High CARES-SF global scores were associated with opioid pain treatment, whereas lower scores were associated with more supportive contacts. Social support, optimism, and coherence were also analyzed as continuous variables, and one additional finding emerged: Higher coherence significantly predicted better CARES global scores. Controlling for treatment assignment did not affect the nature of these findings.

Exploratory Analyses
No relationship was found between any outcomes and intervention dose or satisfaction with the intervention. We also explored whether treatment affected intervention impact, because receipt of chemotherapy and hormonal treatment differed across arms; inclusion of these variables did not affect the findings (data not shown).

Patients were well satisfied with the intervention, with only 12% saying that they were "not at all" satisfied. Eighty-seven percent or more felt that each of 20 aspects of the intervention was satisfactory, good, or excellent, excepting the number of sessions, with 17% of women wanting more sessions.

Patient use of other sources of support was also measured (data not shown). At baseline, women in both arms reported using approximately the same average number of kinds of support (5.2 in the CG and 5.0 in the TG). At 3 months, CG women used significantly (P = .002) fewer services (mean = 4.0) compared with TG patients (mean = 4.8); this difference disappeared 3 months later.

	DISCUSSION

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This article reports the first findings of a phase III randomized trial of telephone counseling versus usual supportive care for women with initial breast cancer recurrence. The study had many strengths, including a standardized protocol, representation from multiple institutions nationwide, quality-control procedures with low levels of missing data, well-matched treatment and control groups, use of validated and interpretable outcome assessments, and achievement of accrual goal. This study demonstrated that psychosocial interventions can be conducted in a cooperative group such as SWOG. This was the first such study for SWOG, and it reflects a successful collaboration with a patient advocacy organization. At the same time, the generalizability of this study is unclear, given that the patients came from multiple institutions across the US, such that the catchment area cannot be precisely described and characteristics of patients who may have refused participation were not monitored.

Although the study demonstrated that this intervention was feasible and well accepted, there were no benefits associated with the intervention for either of the primary outcome measures—psychosocial distress and depressive symptoms—at 3 months postintervention. Potential explanations include weak intervention, intervention effective only for subgroups, temporal improvement in both groups that obscured treatment-arm differences, insufficient observation period, and intervention not well-matched to improving outcomes in this population.

We explored the viability of all of these possibilities. Regarding intervention intensity, we found no relationship between time spent in the intervention and outcomes. However, it is possible that a more intense intervention could have had positive effects.

We tried to identify patient subgroups that experienced benefits of the intervention. For both the psychosocial and depressive symptoms end points, interaction analyses between treatment arm and each of the factors shown in Table 4 were performed. No strong evidence that the intervention was differentially successful within subgroups was found (data not shown).

Regarding temporal changes in patient well-being, both depressive symptoms and psychosocial status improved somewhat over time in both groups, as shown in Table 3. However, patient distress started and remained very high. These data do not support the hypothesis that improvement over time or low baseline distress masked a major impact of the intervention.⁴⁶

It is possible that positive effects could have emerged after the study ended. However, given that about one third of patients had already experienced disease progression at 6 months, many patients likely would have become increasingly affected by breast cancer–related symptoms over time, making emergent intervention effects unlikely.

The final possibility is that this approach is not effective for these patients. We believe that this is the most probable explanation. These women had just been given a very serious diagnosis that, in most cases, meant that breast cancer cure was no longer an option. Not surprisingly, they were highly distressed and depressed. The levels here greatly exceed those reported in other studies; for example, only approximately 27% of Marcus et al's participants reported clinical levels of depressive symptoms (A. Marcus, personal communication, February 2007). Furthermore, nearly one in three women experienced further disease progression during the course of the study. Given this high level of significant psychological and disease-related disability, it is not surprising (in hindsight) that telephone calls designed to provide social support from a nonprofessional could not significantly modify patient distress.

However, there is evidence that the intervention affected outcomes more closely linked to the content of the intervention, and to the expertise of the counselor. As reported, women in the TG used more community services than women in the CG after entry onto the study. The counselors urged the patients to seek out resources to address their concerns, and these findings indicate that they were successful in motivating the women to do so, although the impact had waned by 6 months. Sandgren et al²⁰ found a similar result: Breast cancer patients in their telephone support intervention condition used an oncology nurse call line more than did women in the control arm.

Clearly, it is important to develop effective interventions to address the considerable suffering experienced by breast cancer recurrence patients. Our secondary analyses indicate that women who have in the past received or are currently receiving chemotherapy are more likely to experience distress and depressive symptoms. Although women who receive opioid pain treatment report more depressive symptoms (perhaps because of disease progression), they are also more functional physically and overall. Women who have a high sense of coherence report better psychological functioning and fewer depressive symptoms. Interventions that focus on building a sense of coherence (eg, helping patients to find meaning in their experience and identify realistic goals) may hold promise for future interventions in advanced disease.

Telephone counseling is an appealing strategy, given its low cost and potential to supersede geographic barriers. More research is needed to clarify many aspects of telephone counseling, including the optimal duration, most effective counselors, training and monitoring protocols, and identification of patients most likely to benefit.¹⁶ However, this study did not support the efficacy of peer telephone counseling in improving well-being in women with breast cancer recurrence. For this population, which urgently needs support, we recommend that resources be directed toward more intensive or different types of supportive interventions. Although face-to-face interaction may be the gold standard, new technologies such as professionally moderated Internet chat rooms and Web-based videoconferencing may offer novel future opportunities.

	AUTHORS' DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST

TOP ABSTRACT INTRODUCTION PATIENTS AND METHODS RESULTS DISCUSSION AUTHORS' DISCLOSURES OF... AUTHOR CONTRIBUTIONS Appendix REFERENCES

 
The authors indicated no potential conflicts of interest.

	AUTHOR CONTRIBUTIONS

TOP ABSTRACT INTRODUCTION PATIENTS AND METHODS RESULTS DISCUSSION AUTHORS' DISCLOSURES OF... AUTHOR CONTRIBUTIONS Appendix REFERENCES

 
Conception and design: Carolyn Cook Gotay, Carol M. Moinpour, Dorothy Coleman, Silvana Martino, Kathy S. Albain

Administrative support: Beverly J. Parker, Scott M. Lippman

Provision of study materials or patients: Silvana Martino, James Bearden, Shaker Dakhil, Howard M. Gross, Kathy S. Albain

Collection and assembly of data: Carolyn Cook Gotay, Carol M. Moinpour, Joseph M. Unger, Caroline S. Jiang, Dorothy Coleman, Beverly J. Parker

Data analysis and interpretation: Carolyn Cook Gotay, Carol M. Moinpour, Joseph M. Unger, Caroline S. Jiang, Dorothy Coleman, Silvana Martino, Beverly J. Parker, Kathy S. Albain

Manuscript writing: Carolyn Cook Gotay, Carol M. Moinpour, Joseph M. Unger, Caroline S. Jiang, Kathy S. Albain

Final approval of manuscript: Carolyn Cook Gotay, Carol M. Moinpour, Joseph M. Unger, Caroline S. Jiang, Dorothy Coleman, Silvana Martino, Beverly J. Parker, James Bearden, Shaker Dakhil, Howard M. Gross, Scott M. Lippman, Kathy S. Albain

	Appendix

TOP ABSTRACT INTRODUCTION PATIENTS AND METHODS RESULTS DISCUSSION AUTHORS' DISCLOSURES OF... AUTHOR CONTRIBUTIONS Appendix REFERENCES

 
Counselor Training and Monitoring
The Y-ME counselors were trained to conduct the intervention using a protocol that was developed by Y-ME for ongoing telephone hotline training, supplemented by information about clinical trials and SWOG, how to conduct a research protocol, and materials specific to breast cancer recurrence. This training included procedures for how to handle serious psychosocial disturbances that were detected during a telephone session. For this study, these procedures were supplemented by the counselor asking the patient in such cases if the counselor could contact the SWOG physician handling that patient's care. (In no case did this occur.) As in any study, the patient was free to withdraw from the intervention at any time.

Counselors were trained regarding the format for their interaction, which included providing information in specified areas, active listening when the women discussed their concerns, assistance in problem solving (particularly to help the women define and prioritize their own solutions to problems), and referral to resources that may be helpful (books and other written or audiovisual materials, local and national resources).

Counselor performance was monitored on an ongoing basis. Before being allowed to serve as a counselor for this study, a prospective counselor completed the CES-D. If she scored in the depressed range on the CES-D ( 16), she was not allowed to serve as a counselor. The Y-ME supervisor interviewed candidates in the nondepressed range and referred appropriate candidates to complete the training. Each counselor's session with her first patient was tape-recorded and reviewed by the supervisor and the study coordinator. As needed, she was given feedback to help her improve her performance. The Y-ME supervisor observed (sat in on) subsequent sessions on a random basis. Study coordinators reviewed ongoing counselor notes and patient evaluations of the intervention to identify possible problems for referral to the Y-ME supervisor.

	ACKNOWLEDGMENTS

 
We thank Charles A. Coltman Jr for leadership throughout the development and conduct of this study; consultants Carol Alter, Patti Ganz, and Al Marcus for their valuable input; thank Donna P. Ankerst and Sheryl McCoy for additional statistical assistance; Brian F. Issell for sustained support; Bonnie Taylor, Michelle Melin, and Judy Perotti, all formerly from Y-ME, for their input; the Y-ME counselors who provided the intervention for this study for their participation; the SWOG physicians who referred patients; and the SWOG oncology nurses and clinical research associates who collected data.

	NOTES

 
Supported by an award from the Department of Defense Breast Cancer Research program (DAMD 17-96-1-6009); and in part by the following Public Health Service Cooperative Agreement grant numbers awarded by the National Cancer Institute, Department of Health and Human Services: CA38926, CA32102, CA35119, CA35431, CA35090, CA04919, CA35281, CA12644, CA27057, CA45560, CA35178, CA45377, CA63844, CA45807, CA46441, CA67663, CA58348, CA46282, CA12213, CA35192, CA52654, CA68183, CA35261, CA58416, CA95860, CA63848, CA86780, CA35996, CA16385, CA13612, CA42777, CA20319, CA37981, CA45450, CA14028, CA52654, CA58723, CA74647, CA58686, CA22433, CA58882.

Presented in part at the 27th Annual Charles A. Coltman Jr San Antonio Breast Cancer Symposium, San Antonio, TX, December 8-11, 2004.

The content of this manuscript does not necessarily reflect the position or the policy of the government, and no official endorsement should be inferred.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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Submitted May 16, 2006; accepted February 28, 2007.

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