S9832: Effectiveness of Telephone Counseling By Breast Cancer Survivors on the Well-Being of Women With Recurrent Breast Cancer
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.
|Breast Cancer Psychosocial Effects of Cancer and Its Treatment||Procedure: psychosocial assessment and care|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
|Official Title:||Enhancing Well-Being During Breast Cancer Recurrence. SWOG Study S9832.|
- Assess effectiveness of a telephone intervention delivered by breast cancer survivors on well-being of patients experiencing a first recurrence of breast cancer [ Time Frame: 6 months ]
- Examine impact of sociodemographic, clinical, and psychosocial predictors of well-being in patients experiencing a first recurrence of breast cancer. [ Time Frame: 6 months ]
- Examine changes in well-being over time since recurrence [ Time Frame: 6 months ]
|Study Start Date:||July 1998|
|Study Completion Date:||November 2003|
|Primary Completion Date:||November 2003 (Final data collection date for primary outcome measure)|
No Intervention: Control
Standard level of support after recurrence diagnosis
Phone intervention for patients experiencing first recurrence with quality of life questionnaires, psychosocial assessment and care.
Procedure: psychosocial assessment and care
Questionnaire and telephone intervention
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00031772
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|Study Chair:||Carolyn Gotay, PhD||University of Hawaii Cancer Research Center|