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

Breast Cancer Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Psychosocial Effects of Cancer and Its Treatment

• NCT number: NCT00031772
• Study type: Interventional
• Source: Southwest Oncology Group
• Status: Completed
• Phase: N/A
• Start date: July 1998
• Completion date: November 2003