Family History App for Cancer Prevention

(FHAMe Trial)

Overseen By June Carroll, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Toronto

Disqualifiers: Pregnancy, Non-staff patients, others

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

Compensation: Varies

Number of Visits: 1

627 Participants Needed

Trial Summary

What is the purpose of this trial?

A complete family history (FH) may identify persons at high risk for certain conditions. They can be offered genetic testing and life-saving screening and treatment. In practice, complete FH is rarely collected or entered into the electronic medical record (EMR). The Family History Screening Questionnaire is a survey patients complete to tell whether they are at increased risk of specific cancers, heart disease or diabetes. We will test a new way to record FH that includes an app to improve use of FH by family physicians and patients. The strategy includes education for patients and physicians about the importance of FH; patient completion of the FH questionnaire prior to appointments; and prompts in the EMR. We expect this to help family physicians and patients interpret FH and make the best decisions. We will assess the proportion of patients with new EMR FH information. We will explore if the strategy increases appropriate referrals for screening and genetic consultation for those at increased FH risk. We will also obtain patients' and physicians' feedback on this strategy. This new approach may improve FH information exchange between patients and physicians, encourage shared decision-making and reduce cancer deaths and chronic disease burden.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the FHAMe Intervention treatment for cancer prevention?

Research shows that using family health history tools like MeTree and Family Healthware can help identify individuals at higher risk for certain cancers, such as breast, colorectal, and ovarian cancer, by analyzing family history. These tools provide personalized prevention plans and messages, which have been shown to encourage people to adopt healthier behaviors and undergo appropriate screenings. ^{1 2 3 4 5}

Is the Family History App for Cancer Prevention safe to use?

The research does not provide specific safety data for the Family History App for Cancer Prevention, but similar tools like Family Healthware have been developed and tested for usability and effectiveness in providing personalized prevention messages based on family history. ^{1 4 5 6 7}

How does the Family History App for Cancer Prevention differ from other treatments for cancer prevention?

The Family History App for Cancer Prevention is unique because it uses a digital tool to collect and analyze family health history, providing personalized prevention plans based on genetic, environmental, and behavioral factors. Unlike traditional treatments, it focuses on risk assessment and lifestyle changes rather than medication or direct medical intervention. ^{5 8 9 10 11}

Research Team

June Carroll, Dr.

Principal Investigator

MOUNT SINAI HOSPITAL

Eligibility Criteria

This trial is for individuals aged 30-69 who are patients of staff physicians with an email registered in the OCEAN system. It's not suitable for pregnant individuals or those under the care of resident physicians.

Inclusion Criteria

I am between 30 and 69 years old.

Exclusion Criteria

Must be patients of staff physicians (i.e. no resident patients)

Must have email address registered in the OCEAN system

Pregnancy

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Intervention

Participants complete the Family History Screening Questionnaire and results are integrated into the EMR

6 months

Ongoing electronic interaction

Follow-up

Participants are monitored for changes in risk-appropriate screening and documentation of family history in the EMR

6 months

Data collection and interviews

Treatment Details

Interventions

• FHAMe Intervention

Trial Overview The trial is testing a new app-based approach to recording family health history (FHAMe Intervention) to improve its use by family doctors and patients, aiming to enhance decision-making and increase appropriate referrals for high-risk conditions.

Participant Groups

Group I: Intervention Experimental Treatment 1 Intervention

In addition to usual care, patients will be asked to answer questions about any family history through the use of a questionnaire.

Group II: Usual Care Active Control 1 Intervention

Patients receive usual care, which consists of health care providers inquiring about and dealing with family history as they would in usual practice.

Who Is Running the Clinical Trial?

University of Toronto

Lead Sponsor

Trials

739

Recruited

1,125,000+

Findings from Research

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]

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]

References

1. 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]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Room for improvement in capturing cancer family history in a gynecologic oncology outpatient setting. [2023]

3. Germany pubmed.ncbi.nlm.nih.gov

Effect of Sociodemographic Factors on Uptake of a Patient-Facing Information Technology Family Health History Risk Assessment Platform. [2023]

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

Effect of preventive messages tailored to family history on health behaviors: the Family Healthware Impact Trial. [2023]

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

Developing Family Healthware, a family history screening tool to prevent common chronic diseases. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

FHH Quick App Review: How Can a Quality Review Process Assist Primary Care Providers in Choosing a Family Health History App for Patient Care? [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Family history assessment: impact on disease risk perceptions. [2021]

8. Ireland pubmed.ncbi.nlm.nih.gov

Utility of a virtual counselor (VICKY) to collect family health histories among vulnerable patient populations: A randomized controlled trial. [2022]

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

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

10. England pubmed.ncbi.nlm.nih.gov

Interviews with primary care physicians regarding taking and interpreting the cancer family history. [2021]

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

Population-based study of the prevalence of family history of cancer: implications for cancer screening and prevention. [2023]