A randomized controlled trial of cognitive-behavioral stress management in breast cancer: survival and recurrence at 11-year follow-up
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Non-metastatic breast cancer patients often experience psychological distress which may influence disease progression and survival. Cognitive-behavioral stress management (CBSM) improves psychological adaptation and lowers distress during breast cancer treatment and long-term follow-ups. We examined whether breast cancer patients randomized to CBSM had improved survival and recurrence 8–15 years post-enrollment. From 1998 to 2005, women (N = 240) 2–10 weeks post-surgery for non-metastatic Stage 0–IIIb breast cancer were randomized to a 10-week, group-based CBSM intervention (n = 120) or a 1-day psychoeducational seminar control (n = 120). In 2013, 8–15 years post-study enrollment (11-year median), recurrence and survival data were collected. Cox Proportional Hazards Models and Weibull Accelerated Failure Time tests were used to assess group differences in all-cause mortality, breast cancer-specific mortality, and disease-free interval, controlling for biomedical confounders. Relative to the control, the CBSM group was found to have a reduced risk of all-cause mortality (HR = 0.21; 95 % CI [0.05, 0.93]; p = .040). Restricting analyses to women with invasive disease revealed significant effects of CBSM on breast cancer-related mortality (p = .006) and disease-free interval (p = .011). CBSM intervention delivered post-surgery may provide long-term clinical benefit for non-metastatic breast cancer patients in addition to previously established psychological benefits. Results should be interpreted with caution; however, the findings contribute to the limited evidence regarding physical benefits of psychosocial intervention post-surgery for non-metastatic breast cancer. Additional research is necessary to confirm these results and investigate potential explanatory mechanisms, including physiological pathways, health behaviors, and treatment adherence changes.
KeywordsBreast neoplasm Survival Recurrence Cognitive therapy Behavior therapy Breast cancer
MA, SL, and CC were responsible for the original study conception and design. JS, MA, CC, and LB were responsible for the follow-up study conception and design. JS and MA obtained funding. JS, LB, LG, and DJ collected the data and provided administrative support. AD, BB, SL, GI, SG, and CC provided technical and material support. JS, MA, and QY conducted the statistical analysis. JS, LB, LG, DJ, AD, BB, SL, GI, SG, CC, QY, and MA interpreted the data. JS, LB, LG, DJ, SL, AD, BB, GI, SG, CC, QY, and MA drafted and reviewed the manuscript. JS, CC, SG, SL, GI, and MA provided critical revision of the manuscript for important intellectual content. We are grateful to all of the women who participated in this study. We are appreciative for study coordination efforts from Stephanie Montarroyos, Janny Rodriguez, and the NCI Network of Biobehavioral Pathways in Cancer Steering Committee.
Compliance with ethical standards
Conflict of interest
Dr. Antoni reports receiving publication royalties from a book he co-authored on cognitive-behavioral stress management. Dr. Glück is employed at Celgene Corporation. Other co-authors declare that they have no conflicts of interest.
This project has been funded in whole or in part with Federal funds from the National Cancer Institute (NCI), National Institutes of Health, under Contract No. HHSN261200800001E and NCI grant R01-CA-064710. The content of this publication does not necessarily reflect the views of policies of the Department of Health and Human Services, nor does mention of trade names, commercial products, or organizations imply endorsement by the U.S. Government. The NCI Network of Biobehavioral Pathways in Cancer (under Contract No. HHSN261200800001E) was involved in the design of the study, provided funding for data collection, provided statistical support for data analysis and interpretation through Westat, reviewed and approved the manuscript and the decision to submit the manuscript for publication. The corresponding author had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
Informed consent was obtained from all individual participants included in the study.
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