Genetic Predisposition to DiseaseNCT05186727
Family History and Breast Cancer Education Trial
A study testing Family History education and Patient Ambassador in people with Genetic Predisposition to Disease, run by State University of New York at Buffalo at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Genetic Predisposition to Disease
- What is being tested?
- Family History education and Patient Ambassador
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2021to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 40 years of age and older
- Live in predominately African American communities (ZIP codes)
Who cannot join
- No previous breast cancer diagnosis
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
Read the 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.
- Conditions
- Genetic Predisposition to Disease
- Being tested
- Family History education, Patient Ambassador
- Keywords
- Family History, African American, Breast Cancer Screening
- Medical subject headings
- Genetic Predisposition to Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family History educationOther
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.
Patient AmbassadorOther
The support of a Patient Ambassador in addition to the education is also tested.
| Study group | Role | What they receive |
|---|---|---|
| Researcher-Group | Active comparator | Education delivered in a group session by a member of the research team Receives: Other: Family History education |
| Research-One on One | Active comparator | Education delivered telephonically one-on-one by a member of the research team Receives: Other: Family History education |
| Patient Ambassador-Group | Active comparator | Education delivered in a group session by a Patient Ambassador (a peer mentor) Receives: Other: Family History education; Other: Patient Ambassador |
| Patient Ambassador- One on One | Active comparator | Education delivered telephonically one-on-one by a Patient Ambassador (peer mentor) Receives: Other: Family History education; Other: Patient Ambassador |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 Months Post Intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start1 Apr 2021
- Primary completion31 Aug 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genetic Predisposition to DiseaseStudies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laurene Tumiel Berhalter, State University of New York at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05186727
- Sponsor's protocol ID
- 00005038
- Status last verified
- Oct 2022
- First submitted
- 6 Nov 2021
- Last updated
- 25 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05186727
- Acronym / sponsor ID
- 00005038
- Conditions
- Genetic Predisposition to Disease
- Keywords
- Family History, African American, Breast Cancer Screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 11 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Researcher-Group | Active comparator | Other: Family History educationEducation delivered in a group session by a member of the research team |
| Research-One on One | Active comparator | Other: Family History educationEducation delivered telephonically one-on-one by a member of the research team |
| Patient Ambassador-Group | Active comparator | Other: Family History education, Other: Patient AmbassadorEducation delivered in a group session by a Patient Ambassador (a peer mentor) |
| Patient Ambassador- One on One | Active comparator | Other: Family History education, Other: Patient AmbassadorEducation delivered telephonically one-on-one by a Patient Ambassador (peer mentor) |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 40 years of age and older
- Live in predominately African American communities (ZIP codes)
Key exclusion criteria (1 listed)
- No previous breast cancer diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family History educationThe education, developed in partnership with community partners, intends to assist women to collect family history of breast cancer and share it with their providers. | Other | Patient Ambassador- One on One, Patient Ambassador-Group, Research-One on One, Researcher-Group |
| Patient AmbassadorThe support of a Patient Ambassador in addition to the education is also tested. | Other | Patient Ambassador- One on One, Patient Ambassador-Group |
Primary outcome
Change in Knowledge of Genetic Screening for Breast Cancer
Time frame: Baseline
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
Time frame: 1 week Post Intervention
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
Time frame: 3 Months Post Intervention
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
Time frame: Baseline
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
Time frame: 1 week Post Intervention
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
Time frame: 3 Months Post Intervention
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2022.
- Individual participant dataSharing planned: No
Related trials for Genetic Predisposition to Disease
RecruitingObservational study
Vascular Disease Discovery Protocol
Vascular Dysfunction, Genetic Mutations
RecruitingObservational study
Genetic Analysis of Birt Hogg-Dube Syndrome and Characterization of Predisposition to Kidney Cancer
Kidney Neoplasms, Kidney Cancer
Enrolling by invitationObservational study
Mayo Clinic Tapestry 2.0: Applying Multi-Omics for Scientific Discovery
Genetic Predisposition, Exposure, Environmental
RecruitingObservational study
Hereditary Leiomyomatosis Renal Cell Cancer - Study of the Genetic Cause and the Predisposition to Renal Cancer
Renal Tumor Histology, Cutaneous Leiomyoma
Enrolling by invitation
Breast Cancer Risk Assessment and Management Program
Genetic Predisposition to Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family History education and Patient Ambassador in people with Genetic Predisposition to Disease, run by State University of New York at Buffalo at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Knowledge of Genetic Screening for Breast Cancer (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2022.