Family History and Breast Cancer Education Trial
Primary Purpose
Genetic Predisposition to Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Family History education
Patient Ambassador
Sponsored by
About this trial
This is an interventional health services research trial for Genetic Predisposition to Disease focused on measuring Family History, African American, Breast Cancer Screening
Eligibility Criteria
Inclusion Criteria:
- 40 years of age and older
- Live in predominately African American communities (ZIP codes)
Exclusion Criteria:
- No previous breast cancer diagnosis
Sites / Locations
- SUNY Buffalo
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Researcher-Group
Research-One on One
Patient Ambassador-Group
Patient Ambassador- One on One
Arm Description
Education delivered in a group session by a member of the research team
Education delivered telephonically one-on-one by a member of the research team
Education delivered in a group session by a Patient Ambassador (a peer mentor)
Education delivered telephonically one-on-one by a Patient Ambassador (peer mentor)
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05186727
First Posted
November 6, 2021
Last Updated
October 24, 2022
Sponsor
State University of New York at Buffalo
1. Study Identification
Unique Protocol Identification Number
NCT05186727
Brief Title
Family History and Breast Cancer Education Trial
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
August 31, 2022 (Actual)
Study Completion Date
September 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State University of New York at Buffalo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Women from underserved communities are eligible to participate in the educational workshop and the evaluation of the study. We aim to recruit 200 women; 50 randomized into each arm (researcher group, researcher one-on-one, Patient Ambassador group, Patient Ambassador one-on-one) of the evaluation. Participants will be recruited from community-based sources such as the Buffalo Research Registry, primary care practices, and word of mouth through Patient Voices Network, Our Curls, and other community-based organizations. It is anticipated that most of these women will be African American as recruitment will be geared toward predominately African American communities. A marketing flyer, available in e-mail or print format, will be developed to disseminate through the various community-based strategies. Women will be consented and randomized telephonically. Randomization without replacement will be used for every four women consented to ensure equal groups. The research associate will conduct the baseline assessment will be collected over the telephone to maintain the evaluation separate from the implementation of the curriculum. Curriculum content areas include: Breast health knowledge, Breast cancer knowledge, Family History Genetics, Breast Cancer Genetic Testing Methods, and how to collect family history information. Women randomized into the one-on-one phone interventions will be immediately linked to either the Patient Ambassador or researcher who will be administering the curriculum. An initial contact will be made for introductions, to describe the process and schedule four additional times for phone calls. One phone call will be made per week for four weeks. A packet of materials, that include curriculum handouts and supporting tools, will be sent to the participant for follow-up calls. The Patient Ambassador or professional will then follow up with each participant according to the arranged schedule. For participants randomized to the group sessions, 4 dates will be offered at the time of consent for an average of 12-13 participants at each group. Participants will be asked to choose one date. The same materials and tools will be given to the women at the beginning of the session. The curriculum will be delivered in a more didactic approach with time for group interaction and hands on activities. The sessions will be conducted via ZOOM. A fidelity checklist will be created that a member of the research team will complete for both group sessions and will spot check 20% or the on-on-one needs to complete to ensure completion of the full curriculum and protocols is adhered to. Once a month contacts will be made by the individual that delivered the curriculum as a retention strategy. Assessments are conducted immediately after the intervention and three months after the close of the education. These surveys will consist of the same measures included in the baseline and will add a measure about satisfaction with the curriculum, the facilitator, and the mode of delivery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Genetic Predisposition to Disease
Keywords
Family History, African American, Breast Cancer Screening
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
196 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Researcher-Group
Arm Type
Active Comparator
Arm Description
Education delivered in a group session by a member of the research team
Arm Title
Research-One on One
Arm Type
Active Comparator
Arm Description
Education delivered telephonically one-on-one by a member of the research team
Arm Title
Patient Ambassador-Group
Arm Type
Active Comparator
Arm Description
Education delivered in a group session by a Patient Ambassador (a peer mentor)
Arm Title
Patient Ambassador- One on One
Arm Type
Active Comparator
Arm Description
Education delivered telephonically one-on-one by a Patient Ambassador (peer mentor)
Intervention Type
Other
Intervention Name(s)
Family History education
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Patient Ambassador
Intervention Description
The support of a Patient Ambassador in addition to the education is also tested.
Primary Outcome Measure Information:
Title
Change in Knowledge of Genetic Screening for Breast Cancer
Description
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.
Time Frame
Baseline
Title
Change in Knowledge of Genetic Screening for Breast Cancer
Description
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.
Time Frame
1 week Post Intervention
Title
Change in Knowledge of Genetic Screening for Breast Cancer
Description
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.
Time Frame
3 Months Post Intervention
Title
Change intention to be screened and to gather family history and share with providers
Description
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.
Time Frame
Baseline
Title
Change intention to be screened and to gather family history and share with providers
Description
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.
Time Frame
1 week Post Intervention
Title
Change intention to be screened and to gather family history and share with providers
Description
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.
Time Frame
3 Months Post Intervention
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
40 years of age and older
Live in predominately African American communities (ZIP codes)
Exclusion Criteria:
No previous breast cancer diagnosis
Facility Information:
Facility Name
SUNY Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Family History and Breast Cancer Education Trial
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