A Bio-Psychosocial Intervention Program for Improving Quality of Life in Breast Cancer Survivors - Final Outcome of a Prospective Randomized Trial

Abstract

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.

A 4-Month Whole-Systems Ayurvedic Medicine Nutrition and Lifestyle Intervention Is Feasible and Acceptable for Breast Cancer Survivors: Results of a Single-Arm Pilot Clinical Trial

“…19 Improvements in symptoms and QOL outcomes for survivors may be well accomplished with a comprehensive CIM approach to survivorship care. 76,77…”

Psychological Intervention Improves Quality of Life, but Not Survival in Patients with Early-Stage Cancer: a Systematic Review and Meta-analysis of randomized clinical trials

“…Thirteen studies reported on global QoL and nine studies [19][20][21][22][23][24][25][26][27] reported improved QoL in the intervention group compared to the control group. For emotional QoL, ve out of seven studies [19-21, 28, 29] reported improvement in the intervention group.…”

Intervention Model of Returning to Work Based on the Experience of Breast Cancer Patients

“…As the main force of health education implementation, nursing staff can combine the hospitals and the community to strengthen the continuity of breast cancer rehabilitation care. Psychologically, breast cancer patients should be instructed to learn the skills of psychological adjustment, because good psychosocial adaptability not only can improve their quality of life [23][24][25], but also stimulate their subjective initiative, and further encourage them to actively carry out self-management. In terms of knowledge and skills, the education and the guidance should be carried out according to the characteristics of individuals, work nature, and lifestyle to improve self-management effectiveness.…”