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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve the recording and use of family history in medical care to identify individuals at high risk for certain cancers, heart disease, or diabetes. Participants will use a new app, part of the FHAMe Intervention, to complete a family history questionnaire before doctor visits. This may lead to better screening and genetic testing. The trial will determine if this approach helps doctors and patients make more informed health decisions and increases referrals for further testing. Adults with medical records in a specific system and who are patients of certain doctors are suitable candidates. As an unphased trial, this study offers participants the opportunity to contribute to innovative healthcare solutions that could enhance future medical practices.

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 prior data suggests that this app is safe for improving family history use in cancer prevention?

Research shows that specific safety information for the Family History App for Cancer Prevention (FHAMe) is not available. This app helps gather family medical history to identify individuals at risk for diseases like cancer. Although direct safety data is lacking, the trial is marked as "Not Applicable" in terms of its phase, indicating the app is likely low-risk. The main goal is to enhance how doctors and patients record and use family history.

Since the trial does not involve a new drug or medical procedure, typical medical risks are less likely. Instead, it focuses on using technology to aid better health decisions. For any concerns, discussing them with the trial coordinators or a healthcare provider is advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Family History App for Cancer Prevention because it offers a new way to gather critical family history information that might be missed in standard healthcare visits. By using a digital questionnaire, this approach ensures a more thorough and systematic collection of family health data, potentially leading to earlier cancer risk identification. Unlike the usual care where doctors manually inquire about family history, this app aims to streamline and enhance the accuracy of the information collected, ultimately improving preventive care strategies.

What evidence suggests that this app is effective for improving family history information exchange?

Research has shown that digital health tools can help prevent cancer. One study found that educational programs encouraged more people to undergo breast cancer screening. Another review found that mobile health (mHealth) tools improved cancer screening and early detection outcomes. In this trial, participants in the intervention arm will use the FHAMe Intervention app to provide family history information, potentially leading to more referrals for screening and genetic tests, aiding in the early detection of cancer and other diseases. Participants in the usual care arm will receive standard care without the app. ^{6 7 8 9 10}

Who Is on the Research Team?

June Carroll, Dr.

Principal Investigator

MOUNT SINAI HOSPITAL

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11736414/

Use of Digital Health Interventions for Cancer Prevention ... The purpose of the present scoping review was to identify digital health interventions for cancer prevention designed for people with disabilities.

2. bmcwomenshealth.biomedcentral.com bmcwomenshealth.biomedcentral.com/counter/pdf/10.1186/s12905-023-02816-z.pdf?utm_source=consensus

The effectiveness of educational intervention based on the ... The research results regarding performing three breast cancer screening behaviors, including monthly breast self-examination, clinical examination by the ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9425170/

mHealth Interventions to Improve Cancer Screening and Early ... In the CervixCheck intervention, 83% of the participants reported being either “satisfied” or “very satisfied,” and 85% found the SMS text ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT07120087

Evaluation of an Online Intervention to Educate Women at ... The main objective is to evaluate adherence to a personalized, online breast cancer prevention program focused on lifestyle and its acceptance among women at ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0749208124002808

Effectiveness of Digital-Based Interventions on Physical ... This review aimed to synthesize evidence concerning the effectiveness of VR and mobile-based interventions on physical (pain, fatigue, and sleep) and ...

6. withpower.com withpower.com/trial/phase-prostatic-neoplasms-3-2021-6300e

Family History App for Cancer Prevention (FHAMe Trial) 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 ...

7. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/74/NCT03903874/Prot_SAP_000.pdf

Testing scalable, IVR-supported cancer prevention ... Our research team developed a tailored, IVR-supported physical activity intervention for cancer risk ... This data and safety monitoring plan has ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9532364/

Patient and Provider Web-Based Decision Support for ... After exposure to RealRisks, accurate breast cancer risk perceptions improved in the intervention group compared to the control group with short-term follow-up ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT06864260

Cancer PRevention Through Enhanced EnvironMenT Baseline data will be collected on participants in this arm before community-level built and social environment modifications (intervention) are implemented.

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9877062/

Use a web-app to improve breast cancer risk factors and ... This study aimed to evaluate the preliminary effectiveness of an educational intervention using a web-app to improve knowledge of breast cancer risk factors ...