Family History and Breast Cancer Education Trial
You Cannot Change Your Family History, But You Can Change What You do With it: A Peer-based Education Program to Reduce Breast Cancer Risk in African American Women
1 other identifier
interventional
196
1 country
1
Brief Summary
The overall goal of this study is to reduce breast cancer morbidity and mortality disparities among African American women by actively engaging family history as a tool to modify screening regimens and enhance communication between women and their providers. Therefore, this rationale is reflected the project title: "You cannot change your family history, but you can change what you do with it: A peer-based education program to reduce breast cancer risk in African American women" This study will develop and test an educational curriculum that highlights the importance of knowing family history and sharing it with health care providers. The curriculum will include tools to gather family history and discuss it with providers to guide the delivery of care. The investigators will assess the effectiveness of the curriculum in group and one-on-one settings and when delivered by a Patient Ambassador (peer train-the trainer model) or a researcher. The specific objectives of the study are to: Obj. 1: Develop a CBPR-based curriculum- using a community based participatory research (CBPR) approach, that highlights the importance of family history as a risk factor for breast cancer that includes tools to collect family history information and discuss it with providers to enable a family history based screening regimen. Obj. 2: Train Patient Ambassadors- Patient Ambassadors, women from the community who act as community messengers to deliver the curriculum. Obj. 3: Pilot Implementation and Extensive Evaluation of the Curriculum- Assess two modes of delivery, group vs one-on-one, and Peer Ambassadors vs. a researcher. Obj. 4: Dissemination- of the curricular products, implementation pilot results, and implementation guides for communities and practices- via publications and other channels in preparation for grant submits to enhance the program.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2021
CompletedFirst Submitted
Initial submission to the registry
November 6, 2021
CompletedFirst Posted
Study publicly available on registry
January 11, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2022
CompletedOctober 25, 2022
October 1, 2022
1.4 years
November 6, 2021
October 24, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Change in Knowledge of Genetic Screening for Breast Cancer
The breast cancer genetic counseling knowledge questionnaire will be used to assess knowledge. This tool was validated by nurses, genetic counselors, and a group of employees.
Baseline
Change in Knowledge of Genetic Screening for Breast Cancer
The breast cancer genetic counseling knowledge questionnaire will be used to assess knowledge. This tool was validated by nurses, genetic counselors, and a group of employees.
1 week Post Intervention
Change in Knowledge of Genetic Screening for Breast Cancer
The breast cancer genetic counseling knowledge questionnaire will be used to assess knowledge. This tool was validated by nurses, genetic counselors, and a group of employees.
3 Months Post Intervention
Change intention to be screened and to gather family history and share with providers
Other items to be assessed will include attitude towards screening and family history, intent to be screened, intent to gather family history, and intent to discuss family history of breast cancer with their providers. The PRECEDE-PROCEED model will serve as a framework for the evaluation of intent to change. This model serves as a method to measure the socioecological, educational, and social epidemiological aspects of behavior change.
Baseline
Change intention to be screened and to gather family history and share with providers
Other items to be assessed will include attitude towards screening and family history, intent to be screened, intent to gather family history, and intent to discuss family history of breast cancer with their providers. The PRECEDE-PROCEED model will serve as a framework for the evaluation of intent to change. This model serves as a method to measure the socioecological, educational, and social epidemiological aspects of behavior change.
1 week Post Intervention
Change intention to be screened and to gather family history and share with providers
Other items to be assessed will include attitude towards screening and family history, intent to be screened, intent to gather family history, and intent to discuss family history of breast cancer with their providers. The PRECEDE-PROCEED model will serve as a framework for the evaluation of intent to change. This model serves as a method to measure the socioecological, educational, and social epidemiological aspects of behavior change.
3 Months Post Intervention
Study Arms (4)
Researcher-Group
ACTIVE COMPARATOREducation delivered in a group session by a member of the research team
Research-One on One
ACTIVE COMPARATOREducation delivered telephonically one-on-one by a member of the research team
Patient Ambassador-Group
ACTIVE COMPARATOREducation delivered in a group session by a Patient Ambassador (a peer mentor)
Patient Ambassador- One on One
ACTIVE COMPARATOREducation delivered telephonically one-on-one by a Patient Ambassador (peer mentor)
Interventions
The education, developed in partnership with community partners, intends to assist women to collect family history of breast cancer and share it with their providers.
The support of a Patient Ambassador in addition to the education is also tested.
Eligibility Criteria
You may qualify if:
- years of age and older
- Live in predominately African American communities (ZIP codes)
You may not qualify if:
- No previous breast cancer diagnosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
SUNY Buffalo
Buffalo, New York, 14203, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 6, 2021
First Posted
January 11, 2022
Study Start
April 1, 2021
Primary Completion
August 31, 2022
Study Completion
September 30, 2022
Last Updated
October 25, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share