Given the 3.1 million breast cancer survivors in America, quality of life (QoL) is a vital issue. Bio-psychosocial milieu of survivorship is increasingly important. This study assesses the impact of Bio-psychosocial Intervention (BPSI) on the QoL of breast cancer survivors utilizing Functional Assessment of Cancer Therapy - Breast (FACT-B) instrument. A prospective randomized trial was designed; intervention arm included a 4-hour BPSI coping skills class; control arm received standard of cancer and follow-up care (SOC). Women diagnosed within 2 years of study initiation were eligible. Sample size was based on 8-point difference in FACT-B score, 90% power, 5% type I error, and 20% attrition. FACT-B questionnaire was administered to all patients at baseline and at 6-month intervals. SAS 9.3 software was used to analyze data using Chi-square test for categorical and Wilcoxon rank sum for ordinal data; linear mixed modeling was used for longitudinal analysis. One-hundred and three of 120 (86%) patients were available for analysis. Forty-seven patients were in BSPI arm, and 56 received SOC. For BPSI arm versus SOC arm, the median (interquartile) age (60 [52.68] versus 58 [52.68] years, p = 0.9135), cancer-stage (0:1:2:3 = 11%:41%:35%:13% versus 18%:46%:22%:15%, p = 0.4645), and biology (ER+:triple negative:HER2+ = 74%:9%:16% versus 72%:7%:20%, p = 0.8454), respectively, was similar. Median (25th to 75th centile) FACT-B scores in BPSI versus SOC arms at baseline were 109 (95.121) versus 112 (95, 122) (p = 0.6125); mean (SE) change since baseline at 6, 12, 18, and 24 months was: 7.42 (2.22) versus 7.04 (1.97) (p = 0.8862); 17.0 (2.64) versus -6.09 (2.37) (p < 0.0001); 16.03 (2.53) versus 3.58 (2.29) (p = 0.0004), and 15.48 (1.89) versus 16.4 (1.71) (p = 0.7966), respectively. The inter-group differences remained after adjusting for confounding variables at baseline. The p-value for interaction among groups over 2 years remained <0.0001 except for breast cancer specific concerns. BPSI coping skills class significantly improved the QoL of breast cancer survivors by 1 year post-intervention time point; this difference narrowed at 18 months and disappeared at 24 months.

Background: Given the 3.1 million breast cancer survivors in America, quality of life (QoL) is a vital issue. Bio-psychosocial milieu of survivorship is increasingly important. This study assesses the impact of bio-psychosocial intervention (BPSI) on the QoL 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 BPSI coping skills class; control arm received standard of cancer (SOC) and follow up care. Women diagnosed within 2 years of study initiation were eligible. Sample size was based on 8-point difference in FACT-B score, 90% power, 5% type I error, and 20% attrition. FACT-B questionnaire was administered to all patients at baseline and at 6-month intervals. SAS 9.3 software was used to analyze data using Chi-square test for categorical and Wilcoxon rank sum for ordinal data; linear mixed modeling was used for longitudinal analysis. Results: One hundred and three of 120 (86%) patients were available for analysis. Forty-seven patients were in BSPI arm, and 56 received SOC. For BPSI arm vs. SOC arm, the median (interquartile) age [60 (52, 68) vs. 58 (52, 68)yrs. P = .9135], cancer-stage (0: 1: 2: 3 = 11%: 41%: 35%: 13% vs. 18%: 46%: 22%: 15%, P = .4645), and biology (triple-negative: HER2+ : ER+ = 9%: 74%: 17% vs. 8%: 72%: 20%, P = .8454), respectively, was similar. Mean (SE) FACT-B scores in BPSI vs. SOC arms at 6 months and 1 year were 115.1 (2.2) vs. 114.6 (2.0) (P = .8731) and 124.7(2.8) vs. 101.4 (2.4) (P = .0001). The inter-group difference significantly expanded at 1 year (P = .0001). The 12-month difference persisted when confounding baseline variables were adjusted for in in multivariate modeling. Conclusion: BPSI coping skills class significantly improved the QoL of breast cancer survivors by one year post-intervention time point.