s9832: effectiveness of telephone counseling by breast cancer survivors on the well-being of women with recurrent breast cancer

Conditions: Breast Cancer; Psychosocial Effects of Cancer and Its Treatment

Summary: rationale: telephone counseling by breast cancer survivors may enhance the well-being and quality of life of women who have recurrent breast cancer. purpose: randomized clinical trial to study the effectiveness of telephone counseling by breast cancer survivors on the well-being of women who have recurrent breast cancer.

objectives: * determine whether telephone counseling delivered by breast cancer survivors enhances the well-being of women with recurrent breast cancer. * determine the impact of sociodemographic, clinical, and psychosocial predictors of well-being in these patients. * determine the changes in well-being over time since disease recurrence in these patients. outline: this is a randomized, multicenter study. patients are stratified according to age (under 50 vs 50 and over), time since initial diagnosis (less than 2 years vs 2 years or more), and recurrence site (soft tissue without bone vs soft tissue with bone vs visceral). patients are randomized to one of two study arms. * arm i (control arm): patients receive the standard level of support by continuing to use existing resources. patients receive written materials from the counseling group at 6 months. * arm ii (intervention arm): patients receive weekly telephone counseling sessions by breast cancer survivors over 4 weeks for a total of 4-8 sessions. patients receive written materials from the counseling group after the first session. in both arms, quality of life is assessed at baseline and at 3 and 6 months. projected accrual: a total of 300 patients (150 per study arm) will be accrued for this study within 30 months.

Eligibility criteria:
disease characteristics: * received prior definitive surgical treatment for stage i-iiia breast cancer with or without adjuvant chemotherapy, hormonal therapy, and/or radiotherapy * no more than 56 days since diagnosis of first recurrence * any distant metastatic site, chest wall recurrence, scar recurrence, or nodal recurrence * no ipsilateral breast tumor recurrence after lumpectomy or isolated contralateral new primary breast tumors * receiving or planning to receive first therapy for recurrence * no prior therapy for this recurrence except surgical treatment for in-breast relapse after lumpectomy or local palliative radiotherapy * hormone receptor status: * not specified patient characteristics: age: * not specified sex: * female menopausal status: * not specified performance status: * not specified life expectancy: * not specified hematopoietic: * not specified hepatic: * not specified renal: * not specified other: * no psychiatric diagnosis that would preclude study * must be able to read and understand english prior concurrent therapy: biologic therapy: * see disease characteristics chemotherapy: * see disease characteristics endocrine therapy: * see disease characteristics radiotherapy: * see disease characteristics surgery: * see disease characteristics

Keywords: recurrent breast cancer psychosocial effects of cancer and its treatment