Digital Care Plans for Genetic Predisposition to Cancer

Overseen By Lisa Schwartz, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital of Philadelphia

Disqualifiers: Cognitive impairment, others

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

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether digital care plans with text message reminders can help manage genetic cancer risks in children and teens. The goal is to determine if these plans are user-friendly and effective for families dealing with Cancer Predisposition Syndromes (CPS). Families with a CPS diagnosis in the past five years who have received care at specific hospitals are well-suited for this trial.

As an unphased trial, it offers families the chance to contribute to innovative care solutions that could enhance the management of genetic cancer risks.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that this digital care plan is safe for children and adolescents with Cancer Predisposition Syndromes?

Research has shown that digital care plans are generally safe and easy to use. Studies on similar digital tools for assessing cancer risk have found them effective in helping patients understand their genetic risks. For instance, one study examined a mobile health app for individuals with genetic conditions that increase cancer risk and found it met their needs without causing harm.

These tools assist patients in managing their health by tracking important information and reminders. No major safety issues have been reported in these studies, suggesting that digital care plans, like those being tested, are likely safe for children and teenagers with genetic risks for cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about digital care plans for individuals with a genetic predisposition to cancer because they offer a personalized and proactive approach to managing health. Unlike standard care, which often involves regular in-person consultations and generalized screening schedules, these digital plans provide tailored health management strategies directly to patients' devices. This method includes optional text message reminders, helping patients stay on track with their care and making it easier to integrate into daily life. The convenience and customization of digital care plans have the potential to improve adherence to recommended screening and preventive measures, ultimately leading to better health outcomes.

What evidence suggests that digital care plans are effective for cancer predisposition syndromes?

Research shows that digital care plans can help manage cancer risks in individuals with a genetic predisposition to the disease. In this trial, participants will receive digital care plans with optional text message reminders. Studies have found that digital tools for assessing genetic cancer risk increase the number of patients receiving genetic counseling, ensuring more people get the advice needed to manage their risk. Additionally, digital systems effectively promote genetic testing, crucial for early cancer detection and prevention. These tools tailor healthcare to individual needs, offering a promising option for families with a genetic risk of cancer. ^{6 7 8 9 10}

Who Is on the Research Team?

Suzanne MacFarland, MD

Principal Investigator

Children's Hospital of Philadelphia

Are You a Good Fit for This Trial?

This trial is for children and adolescents over the age of 12, along with their parents or legal guardians, who are being followed up at CHOP for a known Cancer Predisposition Syndrome diagnosed within the last three years. Participants must be able to understand and speak English without cognitive impairments that limit their ability to complete study tasks.

Inclusion Criteria

Parents must have received care at the Cancer Predisposition clinic at the Children's Hospital of Philadelphia (CHOP), or other medical institutions (does not need to be receiving follow-up care at CHOP)

I am a young person diagnosed with a genetic risk for cancer in the last 5 years.

My parents can think clearly and complete tasks without help.

Exclusion Criteria

Not meeting any of inclusion criteria

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive digital care plans and optional text message reminders for Cancer Predisposition Syndromes

3 months

Initial setup visit (virtual or in-person)

Follow-up

Participants are monitored for changes in anxiety, distress, and knowledge scores at 3 and 6 months

6 months

Assessments at 3 and 6 months (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Digital Care Plans

Trial Overview The trial aims to develop and test digital care plans complemented by text message reminders. These tools are designed for young patients with Cancer Predisposition Syndromes to assess how acceptable, feasible, and effective they are in managing health care needs.

How Is the Trial Designed?

Group I: Intervention: Digital Care Plans with Accompanying Text Messages Experimental Treatment 1 Intervention

Investigators will recruit families and patients diagnosed with a Cancer Predisposition Syndrome within 3 years. Participants will be provided with a digital care plan and optional accompanying text message reminders.

Who Is Running the Clinical Trial?

Children's Hospital of Philadelphia

Lead Sponsor

Trials

749

Recruited

11,400,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Human Genome Research Institute (NHGRI)

Collaborator

Trials

273

Recruited

299,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11512827/

Digital innovation for cancer risk assessment allows large- ... Family-history assessment can identify individuals above population-risk for cancer to enable targeted Screening, Prevention and Early ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36906849/

Implementing digital systems to facilitate genetic testing for ... This study examined the uptake of genetic counseling and testing following the use of a digital cancer genetic risk assessment program implemented at 27 health ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0002937825001723

Digital tool for genetic cancer risk assessment in a ... A digital risk stratification tool improved rates of counseling among patients at risk for hereditary cancer syndromes within a racially and ethnically diverse ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1098360025000711

Outcomes and effectiveness of decision aids for families ... Most DAs targeted women (69.6%) with hereditary breast and ovarian cancer syndrome (73.9%) in North America and Europe (81.3%), primarily supporting decisions ...

5. gimjournal.org gimjournal.org/article/S1098-3600%2823%2900815-8/fulltext

An observational study of 4 clinical workflows This study examined the uptake of genetic counseling and testing following the use of a digital cancer genetic risk assessment program ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S1098360023008158

Implementing digital systems to facilitate genetic testing for ... This study examined the uptake of genetic counseling and testing following the use of a digital cancer genetic risk assessment program implemented at 27 health ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11786131/

Developing and Assessing a Scalable Digital Health Tool ... This study describes the development of a pretest education intervention, Nest-CRC, to facilitate the uptake of germline GT among patients with early-onset ...

8. ajog.org ajog.org/article/S0002-9378(25)00172-3/abstract

Digital tool for genetic cancer risk assessment in a ... The primary outcome was the proportion of high-risk patients identified and recommended for hereditary cancer syndrome genetic testing. The ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S2949774424010069

Feasibility of an electronic patient-facing cancer family ... We developed an electronic patient-facing family history collection tool including B-RST 3.0, PREMM 5 risk assessments and “limited family knowledge/structure” ...

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11075126/

A novel mobile health application to support cancer ... A novel mobile health application to support cancer surveillance needs of patients and families with cancer predisposition syndromes.