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
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|ClinicalTrials.gov Identifier: NCT00932997|
Recruitment Status : Completed
First Posted : July 7, 2009
Last Update Posted : June 8, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Cancer Survivor Psychosocial Effects of Cancer and Its Treatment||Behavioral: telephone-based intervention Other: counseling intervention Other: educational intervention Other: questionnaire administration Procedure: psychosocial assessment and care Procedure: quality-of-life assessment||Not Applicable|
- 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.
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Reducing the Burden of Breast Cancer Among African American and Latina Survivors|
|Study Start Date :||October 2006|
|Actual Primary Completion Date :||June 2010|
|Actual Study Completion Date :||June 2010|
Behavioral: telephone-based intervention
- Increased knowledge about the psychological and physical impact of breast cancer [ Time Frame: 9 months post study enrollment ]
- Improved psychological functioning (depression and anxiety) [ Time Frame: 9 months post study enrollment ]
- Improved family and social functioning (changes in family and partner communications) [ Time Frame: 9 months post study enrollment ]
- Predictors of health-related quality of life (demographic, medical care factors, psychological, socio-ecological, and socio-cultural factors) [ Time Frame: 9 months post study enrollment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00932997
|United States, California|
|City of Hope Comprehensive Cancer Center|
|Duarte, California, United States, 91010-3000|
|Principal Investigator:||Kimlin Ashing-Giwa, PhD||City of Hope Comprehensive Cancer Center|