Teleconference Group: Breast Cancer in African Americans (STORY)

This study has been completed.
Sponsor:
Information provided by:
University of South Carolina
ClinicalTrials.gov Identifier:
NCT01339351
First received: April 14, 2011
Last updated: April 19, 2011
Last verified: April 2011
  Purpose

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.


Condition Intervention
Breast Cancer
Behavioral: Therapeutic Group by Teleconference

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Teleconference Group: Breast Cancer in African Americans

Resource links provided by NLM:


Further study details as provided by University of South Carolina:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Fatalism [ Time Frame: Participants are assessed at time one (baseline/pretest) and followed for 16 weeks ] [ Designated as safety issue: No ]
    Powe Fatalism Scale


Enrollment: 185
Study Start Date: June 2005
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Behavioral: Therapeutic Group by Teleconference
10 sessions
Other Name: Support group
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
10 sessions
Other Name: Support group

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • US born
  • African American women
  • age 21 or older
  • diagnosed with invasive/infiltrating ductal carcinoma
  • reside in South Carolina or the borders of North Carolina or Georgia

Exclusion Criteria:

  • Non-english speaking
  • diagnosed with metastatic disease at diagnosis
  • have a major cognitive impairment
  • have a current diagnosis of psychosis
  • are undergoing concurrent treatment for another form of cancer (except basal cell or squamous cell of skin)
  • Participation in another behavioral trial
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01339351

Locations
United States, South Carolina
University of South Carolina
Columbia, South Carolina, United States, 29208
Sponsors and Collaborators
University of South Carolina
Investigators
Principal Investigator: Sue P. Heiney, PhD University of South Carolina
  More Information

Publications:
Responsible Party: Sue P. Heiney, PhD, RN, FAAN, University of South Carolina, College of Nursing
ClinicalTrials.gov Identifier: NCT01339351     History of Changes
Other Study ID Numbers: 2004-62
Study First Received: April 14, 2011
Last Updated: April 19, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of South Carolina:
breast cancer
social connection

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on July 22, 2014