A bio-psychosocial intervention program for improving quality of life in breast cancer survivors: Results of a prospective randomized trial

Abstract

Objective There are 2.9 million breast cancer survivors in United States; this number is expected to be 3.7 million by 2022. Therefore, biopsychosocial issues of survivorship are increasingly important. A prospective randomized trial was designed to assess the impact of biopsychosocial intervention (BPSI), a 4-hour Change Cycle ModelTM coping skills class, on the quality of life of breast cancer survivors utilizing Functional Assessment of Cancer Therapy-Breast (FACT-B) instrument. Methods A prospective randomized trial was designed; intervention arm included a 4-hour biopsychosocial coping skills class using the Change Cycle Model once a month (BPSI); control arm received standard of cancer and follow-up care (SOC). Women diagnosed within 2 years of study initiation were eligible. Sample size was calculated based on 10-point difference in FACT-B score, with 90% power, 5% type I error, and 20% attrition. FACT-B questionnaire was administered to all patients at baseline and at 6-month intervals. One-year data are presented. SAS 9.3 software was used to analyze data using chi-square test for categorical variables and Wilcoxon rank sum for ordinal level data; linear mixed modeling was used for longitudinal analysis. Results One hundred and twenty patients were randomized; 102 patients were available for analysis. Forty-seven patients were in BPSI arm, and 56 received SOC. The median (interquartile range) age [60 (52,68) vs 58 (52,68) yr, p = 0.9135], cancer stage [0:1:2:3 = 11%:41%:35%:13% for BPSI; 18%:46%:22%:15% for SOC; p = 0.4645], and biology [triple negative:HER2+:ER+ in BPSI = 9%:74%:17% for BPSI; 8%:72%:20% p = 0.8454] was similar across both groups. There were statistically difference in insurance status [commercial:underinsured = 64%:36% for BPSI; 42%:58% for SOC; p = 0.0413] and treatments [lumpectomy:mastectomy for BPSI = 85%:15%; for SOC = 60%:40%, p = 0.0110] [chemotherapy for BPSI:SOC = 60%:30%; p = 0.0141] [radiation therapy for BPSI:SOC = 90%:77%; p = 0.1024]. Adjusting for these confounders had little impact on overall quality of life measured by FACT-B scores. FACT-B was not significantly different from baseline at 6-month follow-up; however, at 1-year follow-up the intervention arm had significantly better overall and domain-specific quality-of-life scores, except additional breast cancer-specific concerns (Table). The difference between BPSI and SOC at 6 months also significantly improved by 1-year follow-up. Conclusion Biopsychosocial intervention utilizing a 4-hour Change Cycle Model coping skills class significantly improved the quality of life of breast cancer survivors by 1 year post intervention. (Table Presented).