title: 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.
authors.affiliation: Breast Center of Excellence, Texas Tech University Health Sciences Center, Amarillo, Texas.
authors.forename: Janine
authors.initials: J
authors.lastname: Pettiford
authors.affiliation: Breast Center of Excellence, Texas Tech University Health Sciences Center, Amarillo, Texas.
authors.forename: Sharon
authors.initials: S
authors.lastname: Felts
authors.affiliation: Breast Center of Excellence, Texas Tech University Health Sciences Center, Amarillo, Texas.
authors.forename: Edna
authors.initials: E
authors.lastname: Wischkaemper
authors.affiliation: Breast Center of Excellence, Texas Tech University Health Sciences Center, Amarillo, Texas.
authors.forename: Debbie
authors.initials: D
authors.lastname: Miller
authors.affiliation: University of Massachusetts Medical School, Worcester, Massachusetts.
authors.forename: Sybil
authors.initials: S
authors.lastname: Crawford
authors.affiliation: Breast Center of Excellence, Texas Tech University Health Sciences Center, Amarillo, Texas.
authors.forename: Rakhshanda
authors.initials: R
authors.lastname: Layeequr Rahman
mesh_terms: D001943:Breast Neoplasms / Q000523:psychology*; D000073116:Cancer Survivors / Q000523:psychology*; D003376:Counseling; D005260:Female; D006801:Humans; D008875:Middle Aged; D011446:Prospective Studies; D011788:Quality of Life; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
keywords: breast cancer survivors; quality of life; well-being