Managing menopausal symptoms in breast cancer survivors: results of a randomized controlled trial.

BACKGROUND Menopausal symptoms (e.g., hot flashes, vaginal dryness, and stress urinary incontinence) are very common in breast cancer survivors and cannot be managed with standard estrogen replacement therapy (ERT) in these patients. The purpose of this study was to test the efficacy of a comprehensive menopausal assessment (CMA) intervention program in achieving relief of symptoms, the improvement in quality of life (QOL), and sexual functioning in breast cancer survivors. METHODS Using a two-group, randomized controlled design, we assigned 76 postmenopausal breast cancer survivors with at least one severe target symptom either to the intervention group or to a usual-care group. Seventy-two women were evaluable at the end of the study period. The CMA intervention, delivered by a nurse practitioner, focused on symptom assessment, education, counseling and, as appropriate, specific pharmacologic and behavioral interventions for each of the three target symptoms. Psychosocial symptoms were assessed with the use of a self-report screening instrument, and distressed women were referred for counseling if needed. The intervention took place over a 4-month period. Outcomes measured were scores on a composite menopausal symptom scale, the RAND Short Form Health Survey Vitality Scale, and the Cancer Rehabilitation Evaluation System (CARES) Sexual Functioning Scale at baseline and at 4-month follow-up. All statistical tests were two-sided and were performed at the alpha =. 05 significance level. RESULTS Patients receiving the intervention demonstrated statistically significant improvement (P =.0004) in menopausal symptoms but no significant change in vitality (P =.77). Sexual functioning was statistically significantly improved (P =.04) in the treatment group compared with the usual-care group. CONCLUSIONS A clinical assessment and intervention program for menopausal symptom management in breast cancer survivors is feasible and acceptable to patients, leading to reduction in symptoms and improvement in sexual functioning. Measurable improvement in a general QOL measure was not demonstrated.