Ganz, P. A., Greendale, G. A., Petersen, L., Zibecchi, L., Kahn, B., & Belin, T. R. (2000). Managing menopausal symptoms in breast cancer survivors: results of a randomized controlled trial. Journal of the National Cancer Institute, 92, 1054-1064.

This study intended to test the effectiveness of a comprehensive menopausal assessment (CMA) on symptom relief, quality of life, and sexual functioning.

Participants were randomized by age (≤55 and >55) and tamoxifen use (current vs. not used). The CMA was delivered by a trained nurse practitioner with a specialty in family and women’s health over a 4-month period and focused on structured symptom assessment of hot flashes, vaginal dryness, and stress urinary incontinence. After assessment, patients were provided with individualized education and counseling, psychosocial support, referrals, and individualized follow-up. Specific pharmacologic and behavioral interventions for the target symptoms were implemented to control symptoms based on treatment protocols developed by the NP and the study physician. The intervention group returned for a 2-month follow-up visit. The usual care group received a telephone call 2 months after baseline to ask about therapies used to manage their symptoms. Data was collected at baseline and 4 months. The usual care group was then able to take part in the CMA but no further data was collected.

• The study enrolled 42 women with breast cancer.

• SITE:  Single site    
• SETTING TYPE : Outpatient    
• LOCATION: California/community recruitment

PHASE OF CARE: Late effects and survivorship

This was a randomized, controlled trial.

• Menopausal Symptom Scale Score (adapted from the Breast Cancer Prevention Trial Symptom Checklist)
• Vitality Scale from the RAND 36-item Health Survey (aka Medical Outcomes Study SF-36)
• Sexual Summary Scale from the Cancer Rehabilitation Evaluation (CARES)

97% of women in the study reported hot flashes at baseline, with no difference between groups. There was a significant difference in the menopause symptom scale (p=.0004), with women in the intervention group showing the most improvement in symptoms. There was no difference between groups in QOL (p=.77). The CMA group had significantly better sexual functioning at follow-up compared to the usual care group (p=.02). No specific data on improvement in hot flashes was provided. Only the overall symptom scale was reported.

CMA is an effective intervention to improve/reduce the number of menopausal symptoms in breast cancer survivors and to improve sexual function for these women.

Limitations of the study included:

• Small sample (< 100)
• Risk of bias (no blinding)
• Intervention expensive, impractical, or training needs
• Requires a specially trained nurse practitioner for the intervention

A nurse-led intervention to target menopausal symptoms is an effective way to reduce these symptoms in women who are survivors of breast cancer. However, the intervention may be too expensive or impractical given the training requirements of the intervention nurse and institutional guidelines on billable appointments.