Survivorship Booklets With or Without Individual Telephone Sessions in Increasing Knowledge About the Impact of Breast Cancer in African American and Latina Breast Cancer Survivors

Breast Cancer Clinical Trial

Official title: Reducing the Burden of Breast Cancer Among African American and Latina Survivors

Status Completed

Clinical Trial Summary

RATIONALE: Telephone sessions and survivorship booklets may increase knowledge about the psychological and physical impact of breast cancer and increase awareness of available resources. It is not yet known whether survivorship booklets are more effective when given alone or together with individual telephone sessions in informing breast cancer survivors.

PURPOSE: This randomized clinical trial is studying individual telephone sessions given together with survivorship booklets compared with survivorship booklets alone to see how well they work in increasing knowledge about the impact of breast cancer in African American and Latina breast cancer survivors.

Clinical Trial Description

OBJECTIVES:

Primary

• Evaluate the utility of individual telephone sessions plus survivorship booklets versus the survivorship booklets alone in increasing knowledge about the psychological and physical impact of breast cancer and increasing awareness of appropriate psychological and medical resources among African American and Latina breast cancer survivors.

• Evaluate the utility of these interventions in improving psychological functioning (depression and anxiety) among breast cancer survivors.

• Evaluate the utility of these interventions in improving family and social functioning (changes in family and partner communications) among breast cancer survivors.

Secondary

• Evaluate predictors of health-related quality of life (demographic, medical care factors, psychological, socio-ecological, and socio-cultural factors) within and across breast cancer survivors ethnic groups to identify both general and ethnic-specific correlates.

OUTLINE: Patients are stratified according to ethnicity (African American vs Latina). Patients are randomized to 1 of 2 groups.

• Group 1: Patients receive a survivorship kit of booklets in English or Spanish. Patients then receive a follow-up telephone call at approximately 2 months to clarify any issues relevant to the survivorship kit of booklets.

• Group 2: Patients participate in 8 weekly telephone sessions addressing basic breast cancer information; education about psychological and medical effects of cancer and its treatments; resources including psychosocial, medical care facilities, and clinical trials information; stress management and relaxation; cognitive reframing of concerns and behavioral strategies; family communication; relational communication and intimacy; and social support. Patients also receive a survivorship kit of booklets as in group 1.

After completion of study intervention, patients complete follow-up questionnaires at 4 to 6 months. ;

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

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

• NCT number: NCT00932997
• Study type: Interventional
• Source: City of Hope Medical Center
• Status: Completed
• Phase: N/A
• Start date: October 2006
• Completion date: June 2010