Family Health History Assessment for Cancer Risk

(FOREST Trial)

Recruiting at 1 trial location

Overseen By Harris Bland, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University Medical Center

Disqualifiers: Terminal illness, Non-study site, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

1765 Participants Needed

Trial Summary

What is the purpose of this trial?

Investigators from Vanderbilt University Medical Center (VUMC), Duke University, and Meharry Medical College (MMC) are collaborating on a family health history study to deploy a family health history (FHH) platform, MeTree. Recruited participants will complete surveys, the MeTree questionnaire, and MeTree will determine the participant's cancer risk based on current guidelines. The study team will offer genetic counseling to high-risk participants. Investigators will track participant outcomes and behaviors from the use of MeTree to determine the efficiency of the use of MeTree compared to completion of pedigrees in clinic.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment MeTree Questionnaire, MeTree Platform, MeTree Tool, Genomic Medicine Model for assessing cancer risk?

The MeTree tool, part of the Genomic Medicine Model, has been shown to effectively identify patients at increased risk for breast, ovarian, and colon cancer by using family health history. It helps in generating clinical decision support, which can guide prevention strategies and improve patient and provider experiences in primary care settings. ^{1 2 3 4 5}

Is the MeTree Questionnaire safe for use in humans?

The MeTree Questionnaire is a tool for collecting family health history and does not involve any medical treatment or medication, so it is generally safe for use in humans. ^{2 3 4 5 6}

How does the Family Health History Assessment for Cancer Risk treatment differ from other treatments?

This treatment is unique because it uses web-based tools like MeTree and Health Heritage to collect and analyze family health history, which helps in assessing cancer risk more accurately and efficiently than traditional methods. These tools provide personalized risk assessments and recommendations, making them a novel approach in integrating family history into primary care for cancer prevention. ^{2 4 5 7 8}

Research Team

Georgia Wiesner, MD

Principal Investigator

Vanderbilt University Medical Center

Eligibility Criteria

This study is for English-speaking individuals who are comfortable using the internet and are patients at specific sites included in the study. They must be willing to enroll or already be enrolled in a patient portal (specifically for VUMC). People with terminal illnesses, previous genetic counseling or testing from VUMC's Hereditary Cancer Clinic, or those not receiving care at study sites cannot participate.

Inclusion Criteria

I am signed up or willing to sign up for the patient portal.

Willing to use the Internet

Able to read and communicate in English

Exclusion Criteria

I have had genetic testing or counseling at the VUMC Hereditary Cancer Clinic.

Diagnosed with a terminal illness

Unable/unwilling to use the Internet

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Enrollment and Assessment

Participants complete the MeTree questionnaire and are assessed for cancer risk based on current guidelines

3 years

Regular reminders and support for survey completion

Genetic Counseling and Referral

High-risk participants are offered genetic counseling and referred to specialists as needed

4 years

Telephone and video counseling sessions

Follow-up

Participants are monitored for outcomes and behaviors related to the use of MeTree

4 years

Treatment Details

Interventions

• MeTree Questionnaire

Trial Overview The trial is examining how well MeTree, a family health history platform, can assess cancer risk based on guidelines. Participants will fill out surveys and the MeTree questionnaire. High-risk participants will receive genetic counseling. The effectiveness of MeTree will be compared to traditional pedigree assessments.

Participant Groups

Group I: High Risk / MeTree Experimental Treatment 1 Intervention

High risk for hereditary cancer and completes the MeTree questionnaire

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

The Family History Assessment Tool (FHAT) was developed to help physicians identify individuals at higher risk for BRCA1 and BRCA2 mutations, effectively streamlining the referral process for genetic counseling.

In a study involving 184 families with breast or ovarian cancer, FHAT successfully reduced unnecessary referrals while ensuring that mutation-positive individuals were not overlooked, demonstrating its efficacy in risk assessment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A preliminary validation of a family history assessment form to select women at risk for breast or ovarian cancer for referral to a genetics center. Gilpin, CA., Carson, N., Hunter, AG.[2019]

The MeTree tool for collecting family health history was well-received by both patients and providers, with 98% of patients finding it useful and 93% of providers recommending it to peers, indicating its potential to enhance patient care.

Integration of MeTree into primary care practices was smooth, taking an average of 27 minutes for patients to complete, and it significantly raised awareness of disease risk, particularly among older patients who may need assistance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient and primary care provider experience using a family health history collection, risk stratification, and clinical decision support tool: a type 2 hybrid controlled implementation-effectiveness trial. Wu, RR., Orlando, LA., Himmel, TL., et al.[2021]

In a study involving 1,184 adults, the Genomic Medicine Model identified that 44% of participants were at increased risk for conditions like breast/ovarian cancer and colon cancer, highlighting the importance of family health history in risk assessment.

The implementation of the MeTree program in primary care settings not only identified individuals needing additional screenings and genetic counseling but also indicated a potential increase in demand for these resources, particularly for colon cancer screenings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing family health history risk stratification in primary care: impact of guideline criteria on populations and resource demand. Orlando, LA., Wu, RR., Beadles, C., et al.[2015]

The Health Heritage tool significantly improved the completeness and accuracy of family health history collection, identifying 60% of elevated risk conditions compared to only 24% identified through Usual Care in a study of 109 volunteers.

Participants using Health Heritage reported a high level of understanding (63%) and a notable intention to change health behaviors (56%), highlighting its potential impact on personal health management and the future of personalized genomic medicine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health Heritage© a web-based tool for the collection and assessment of family health history: initial user experience and analytic validity. Cohn, WF., Ropka, ME., Pelletier, SL., et al.[2022]

MeTree is a validated, web-based tool designed to help primary care providers collect and synthesize family health history, which is crucial for assessing disease risk and guiding prevention strategies.

The tool was developed with stakeholder feedback and tested in community-based clinics, demonstrating its ability to integrate seamlessly into clinical practice and provide actionable recommendations, although it was validated in a small cohort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and validation of a primary care-based family health history and decision support program (MeTree). Orlando, LA., Buchanan, AH., Hahn, SE., et al.[2021]

The OurFamilyHealth tool was developed to improve the collection of family health history data, which is essential for personalized medicine and risk assessment in clinical settings.

Early usage statistics show that the tool enhances data availability compared to traditional family history charting in electronic health records, indicating its potential to support better clinical decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and early usage patterns of a consumer-facing family health history tool. Hulse, NC., Ranade-Kharkar, P., Post, H., et al.[2022]

The Genetic Risk Easy Assessment Tool (GREAT) effectively collects detailed family cancer histories, showing high reliability and validity when compared to traditional methods used by genetic counselors, with 63% of cancers identified by both methods.

The automated tool is user-friendly, taking an average of 33.5 minutes to complete, and demonstrates strong agreement in risk assessments for breast cancer, indicating it can be a valuable resource for cancer risk assessment in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of a self-administered, computerized tool for collecting and displaying the family history of cancer. Acheson, LS., Zyzanski, SJ., Stange, KC., et al.[2022]

A web-based questionnaire tool for assessing family history related to colorectal cancer (CRC) was developed and validated, showing effective risk assessment capabilities based on local guidelines.

The questionnaire-based interface was significantly more satisfying for users compared to a diagram-based version, although both tools were equally effective in calculating CRC risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family history assessment for colorectal cancer (CRC) risk analysis - comparison of diagram- and questionnaire-based web interfaces. Schultz, M., Seo, SB., Holt, A., et al.[2018]

References

1. Denmark pubmed.ncbi.nlm.nih.gov

A preliminary validation of a family history assessment form to select women at risk for breast or ovarian cancer for referral to a genetics center. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Patient and primary care provider experience using a family health history collection, risk stratification, and clinical decision support tool: a type 2 hybrid controlled implementation-effectiveness trial. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Implementing family health history risk stratification in primary care: impact of guideline criteria on populations and resource demand. [2015]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Health Heritage© a web-based tool for the collection and assessment of family health history: initial user experience and analytic validity. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Development and validation of a primary care-based family health history and decision support program (MeTree). [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Development and early usage patterns of a consumer-facing family health history tool. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Validation of a self-administered, computerized tool for collecting and displaying the family history of cancer. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Family history assessment for colorectal cancer (CRC) risk analysis - comparison of diagram- and questionnaire-based web interfaces. [2018]