Family Health History Assessment for Cancer Risk

(FOREST Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how effectively a tool called MeTree can assess family health history to predict cancer risk. Participants will complete surveys and the MeTree questionnaire to determine their hereditary cancer risk level. Those identified as high-risk may receive genetic counseling to better understand their situation. The trial is designed for English-speaking patients at specific sites who are comfortable using the internet and have not previously received genetic testing or counseling at the VUMC Hereditary Cancer Clinic. The study will track outcomes to determine if MeTree is more effective than traditional methods. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance cancer risk prediction for future patients.

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 prior data suggests that the MeTree platform is safe for assessing cancer risk?

Research shows that the MeTree Questionnaire safely assesses family health history and cancer risk. MeTree inquires about diet, exercise, and family health history to determine risk for certain health issues. Studies have found MeTree easy to use, without involving medical procedures or medications. This eliminates physical risks or side effects associated with other treatments. As an online questionnaire, the primary concern is maintaining privacy and security of information. From a safety perspective, MeTree is well-tolerated and poses minimal risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the MeTree Questionnaire because it offers a personalized approach to assessing cancer risk based on family health history. Unlike traditional methods, which often rely on broad screenings or genetic tests, MeTree provides a tailored risk assessment by capturing detailed family history data. This can help identify individuals at high risk for hereditary cancers more accurately and earlier, potentially leading to proactive and personalized healthcare strategies. By focusing on family history, MeTree may uncover risks that standard screenings might miss, offering a more comprehensive view of an individual's cancer risk landscape.

What evidence suggests that the MeTree platform is effective for assessing cancer risk?

Research shows that the MeTree Questionnaire, which participants in this trial will complete, effectively assesses cancer risk using family health history. Studies have demonstrated that MeTree collects patient information to create a personalized report and family tree, identifying inherited cancer risks. This tool helps doctors make informed decisions based on specific risk guidelines. Participants can view and download a personalized report outlining their specific risk factors. This approach ensures patients receive advice tailored to managing their cancer risk. ^{3 4 5 6 7}

Who Is on the Research Team?

Georgia Wiesner, MD

Principal Investigator

Vanderbilt University Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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 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 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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05079334

NCT05079334 | Family History and Cancer Risk Study Recruited participants will complete surveys, the MeTree questionnaire, and MeTree will determine the participant's cancer risk based on current guidelines.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5215064/

Development and Validation of a Primary Care-Based ... In order to maximize the effectiveness of the tool while minimizing the burden of using it, only the top-ranked 48 conditions were incorporated into MeTree.

3. sciencedirect.com sciencedirect.com/science/article/pii/S1551714424002970

Family history and cancer risk study (FOREST): A clinical ... MeTree uses patient-reported FHH data to generate a pedigree and create a personalized report as well as provider-directed clinical decision support. We are ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06278883

Genomic Medicine Risk Assessment Care for Everyone Once data entry in MeTree is complete, all participants will be able to view and download a personalized patient report within the platform outlining their ...

5. nature.com nature.com/articles/gim2015210

Clinical utility of a Web-enabled risk-assessment and ... MeTree, a Web-based, patient-facing risk-assessment and clinical decision support tool, is designed to facilitate uptake of risk-stratified guidelines.

6. medicine.duke.edu medicine.duke.edu/divisions/general-internal-medicine/precision-medicine/risk-assessment/metree

MeTree - Duke Department of Medicine The tool collects personal history on diet, exercise, smoking, and clinical data to calculate the Gail, BRCApro, and Framingham scores, in addition to personal ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05079334

NCT05079334 | Family History and Cancer Risk Study MeTree is a patient driven risk assessment program with Clinical Decision Support (CDS) that enables collection of a three plus generation family health history ...