Enhancing Well-Being During Breast Cancer Recurrence. SWOG Study S9832.
Brief description: 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.
Detailed description: 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.
Detailed description: 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.