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Clinical Trials/NCT00031772
NCT00031772
Completed
Not Applicable

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

SWOG Cancer Research Network108 sites in 1 country322 target enrollmentJuly 1998

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
SWOG Cancer Research Network
Enrollment
322
Locations
108
Primary Endpoint
Assess effectiveness of a telephone intervention delivered by breast cancer survivors on well-being of patients experiencing a first recurrence of breast cancer
Status
Completed
Last Updated
13 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
July 1998
End Date
November 2003
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Examine impact of sociodemographic, clinical, and psychosocial predictors of well-being in patients experiencing a first recurrence of breast cancer.(6 months)
  • Examine changes in well-being over time since recurrence(6 months)

Study Sites (108)

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