NCT01339351

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
185

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Jun 2005

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 14, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 20, 2011

Completed
Last Updated

April 18, 2019

Status Verified

April 1, 2019

Enrollment Period

5.2 years

First QC Date

April 14, 2011

Last Update Submit

April 16, 2019

Conditions

Breast Cancer

Keywords

breast cancersocial connection

Outcome Measures

Primary Outcomes (1)

  • Social connection

    Measured using the social well-being scale from the FACT-B

    Participants are assessed at time one (baseline/pretest) and followed for 16 weeks

Secondary Outcomes (1)

  • Fatalism

    Participants are assessed at time one (baseline/pretest) and followed for 16 weeks

Study Arms (2)

Usual Psychosocial Care

NO INTERVENTION

Participants are free to use any psychosocial care available to cancer patients. No restrictions to participation in other groups or services.

Therapeutic Group by teleconference

EXPERIMENTAL

ten 90 minute group sessions by teleconference. Lead by social workers. Sessions focus on information, story sharing and coping.

Behavioral: Therapeutic Group by Teleconference

Interventions

Therapeutic Group by TeleconferenceBEHAVIORAL

10 sessions

Also known as: Support group
Therapeutic Group by teleconference

Eligibility Criteria

Age21 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of South Carolina

Columbia, South Carolina, 29208, United States

Location

Related Publications (1)

  • Heiney SP, Adams SA, Wells LM, Johnson H. Evaluation of conceptual framework for recruitment of African American patients with breast cancer. Oncol Nurs Forum. 2010 May;37(3):E160-7. doi: 10.1188/10.ONF.E160-E167.

    PMID: 20439201RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Self-Help Groups

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

OrganizationsHealth Care Economics and Organizations

Study Officials

  • Sue P. Heiney, PhD

    University of South Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Professor

Study Record Dates

First Submitted

April 14, 2011

First Posted

April 20, 2011

Study Start

June 1, 2005

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

April 18, 2019

Record last verified: 2019-04

Locations

US(1)