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Teleconference Group: Breast Cancer in African Americans (STORY) (STORY)

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ClinicalTrials.gov Identifier: NCT01339351
Recruitment Status : Completed
First Posted : April 20, 2011
Last Update Posted : March 11, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Breast Cancer Behavioral: Therapeutic Group by Teleconference

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Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 185 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Teleconference Group: Breast Cancer in African Americans
Study Start Date : June 2005
Primary Completion Date : August 2010
Study Completion Date : August 2010

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U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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
10 sessions
Other Name: Support group


Outcome Measures

Primary Outcome Measures :
  1. Social connection [ Time Frame: Participants are assessed at time one (baseline/pretest) and followed for 16 weeks ]
    Measured using the social well-being scale from the FACT-B


Secondary Outcome Measures :
  1. Fatalism [ Time Frame: Participants are assessed at time one (baseline/pretest) and followed for 16 weeks ]
    Powe Fatalism Scale


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

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): 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: University of South Carolina
ClinicalTrials.gov Identifier: NCT01339351     History of Changes
Other Study ID Numbers: 2004-62
First Posted: April 20, 2011    Key Record Dates
Last Update Posted: March 11, 2015
Last Verified: April 2011

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