Abstract B22: Effectivness of a family-focused intervention to treat persistent fatigue in breast cancer surivivors: A pilot randomized trial

Abstract

Abstract B22 Background Thirty to forty percent of breast cancer survivors suffer from persistent fatigue lingering months to years after adjuvant therapy is completed. This persistent fatigue affects family dynamics feeding a continuing cycle of additional stress and resultant fatigue. We developed a mind-body medicine group intervention and demonstrated a forty percent reduction in fatigue with benefits persisting six months post intervention. A pilot randomized trial was conducted to test if combining the mind-body medicine group intervention with a family-focused intervention is more effective in reducing fatigue for breast cancer survivors than the group intervention only. For the family intervention, family members attended two of the eight weekly sessions and had two family-based counseling sessions with the clinical research therapist. Methodology Subjects who were at least three months post-completion of adjuvant chemotherapy and/or radiation therapy for breast cancer with a baseline fatigue score of <50 as measured by the vitality subscale of the SF-36 Health Survey were randomized to either the group mind-body medicine program or the group program with the integrated family intervention. Thirty-six women entered the pilot study but three dropped out after attending less than two of the eight weekly sessions and were not able to be evaluated. The primary outcome assessed was change in severity of fatigue as measured by the Piper Fatigue Scale. Results Seventeen women were randomized to the family intervention and nineteen to the comparison group intervention. There was no statistically significant difference between the groups by age, martial status or years of education. Those randomized to the family group were on average 4.8 years from the diagnosis of breast cancer compared to 2.8 for the comparison group intervention. Participants in both groups had a statistically significant improvement in fatigue scores at end-of-program with further improvement at two-month follow-up compared to baseline. Mean fatigue scores for the family intervention arm: (baseline-5.7; end -of-program-3.1; two-month-1.4; p<0.001). Fatigue scores for comparison group (baseline-6.5; end-of-program-3.4; two-month-2.7; p<0.001). Comparing the two intervention arms, there were no statistically significant differences at end-of-program (p=0.71) or at two-month follow-up (p=0.14). Recruitment for the trial was challenging, primarily due to the time commitment required from both the survivors and family members. Conclusions A holistic mind-body medicine intervention significantly improved fatigue but augmenting the program with an additional family component did not result in significant incremental improvement in fatigue. Qualitative data from interviews with participants noted that both family members and survivors found benefit in shared learning about fatigue and effective interventions and in discussing their feelings and concerns during counseling sessions. Although this pilot study had limited power to detect a difference between the two arms, the challenges in recruitment for the study suggest that future interventions require a more efficient method to incorporate family members into the program. Citation Information: Cancer Prev Res 2008;1(7 Suppl):B22.