Teleconference Group: Breast Cancer in African Americans (STORY)
African American women with breast cancer have decreased quality of life (and mood when compared to European American. Research has not examined the effectiveness of therapeutic group for African American women with breast cancer even though positive effects are well established for Caucasians. The aims of the randomized clinical trial are to determine the effectiveness of TG by teleconference for African American women with breast cancer and what factors may impact on the intervention. The primary hypothesis is that participants in the intervention group will have significantly greater cancer knowledge, less fear, less isolation, better social connection, better mood, and better QOL when compared to a control group receiving usual psychosocial care. Two hundred forty African American women with breast cancer will be recruited. Intervention participants attend eight weekly 90 minute sessions by teleconference and two follow-up boosters. Each culturally appropriate session contains the story, information and group processes of connection, commonality and catharsis. Information focuses on increasing self care and stress management knowledge while countering myths and taboos. Story capitalizes on African American oral traditions by discussing coping parables. Group processes provide an alternative source of social support and opportunities to express feelings. Control group subjects receive standard psychosocial care (the use of any support programs or services locally or nationally. Testing will occur at baseline, after 10 group sessions and 16 weeks post baseline. The study findings are expected to inform about the effectiveness of therapeutic groups in African American women with breast cancer and lay the groundwork for exploring if reducing disparities in psychosocial care have a health benefit.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Teleconference Group: Breast Cancer in African Americans|
- Social connection [ Time Frame: Participants are assessed at time one (baseline/pretest) and followed for 16 weeks ] [ Designated as safety issue: No ]Measured using the social well-being scale from the FACT-B
- Fatalism [ Time Frame: Participants are assessed at time one (baseline/pretest) and followed for 16 weeks ] [ Designated as safety issue: No ]Powe Fatalism Scale
|Study Start Date:||June 2005|
|Study Completion Date:||August 2010|
|Primary Completion Date:||August 2010 (Final data collection date for primary outcome measure)|
No Intervention: Usual Psychosocial Care
Participants are free to use any psychosocial care available to cancer patients. No restrictions to participation in other groups or services.
Experimental: Therapeutic Group by teleconference
ten 90 minute group sessions by teleconference. Lead by social workers. Sessions focus on information, story sharing and coping.
Behavioral: Therapeutic Group by Teleconference
Other Name: Support group
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01339351
|United States, South Carolina|
|University of South Carolina|
|Columbia, South Carolina, United States, 29208|
|Principal Investigator:||Sue P. Heiney, PhD||University of South Carolina|