NCT00031772

S9832: Effectiveness of Telephone Counseling By Breast Cancer Survivors on the Well-Being of Women With Recurrent Breast Cancer

Enhancing Well-Being During Breast Cancer Recurrence. SWOG Study S9832.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 322 (actual)
• Sponsor: SWOG Cancer Research Network · Network
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Breast Cancer
• Psychosocial Effects of Cancer and Its Treatment

Interventions

Type	Name	Description
PROCEDURE	psychosocial assessment and care	Questionnaire and telephone intervention

Timeline

• Start date: 1998-07-01
• Primary completion: 2003-11-01
• Completion: 2003-11-01
• First posted: 2003-01-27
• Last updated: 2013-02-15

Locations

109 sites across 2 countries: United States, Canada