Web Resources + Personalized Outreach for Cancer Risk Management

(CARE-HCS Trial)

Enrolling by invitation at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

Disqualifiers: Hospice, Palliative care, Dementia, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new methods to help individuals follow risk management plans after cancer genetic testing. It examines the use of web resources and personalized phone calls to support adherence to healthcare plans. Participants may qualify if they carry a specific gene linked to cancer risk and meet medical guidelines for managing that risk. The trial aims to improve plan usage, potentially leading to longer, healthier lives. As an unphased trial, it offers a unique opportunity to contribute to innovative strategies that could enhance healthcare management for many.

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. It focuses on improving access to cancer risk management after genetic testing, so it's best to discuss your medications with the trial team.

What prior data suggests that these interventions are safe for improving cancer risk management?

Research has shown that personalized outreach and online resources can help people manage their cancer risk. Personalized outreach involves a care manager contacting patients to discuss their health needs. This method effectively connects people with healthcare support by improving communication between patients and healthcare providers.

Online resources offer information about cancer prevention and care. Studies indicate that these resources educate people about their health effectively. They are user-friendly, allowing access to information at any time.

Both methods aim to assist people in managing their health after genetic testing for cancer risk. No major safety concerns have been associated with either approach. Both are designed to be easy and safe to use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to enhance cancer risk management. Unlike the standard care, which often depends on patients proactively seeking information and scheduling screenings, this trial tests personalized outreach and web resources to bridge that gap. Personalized outreach involves a care coordinator directly contacting patients around their birthday to discuss necessary screenings and even facilitating the process by placing orders. Meanwhile, the web resources provide patients with tailored materials in their preferred language, ensuring they have easy access to important information. These methods aim to improve patient engagement and adherence to screening schedules, potentially leading to earlier detection and better outcomes.

What evidence suggests that this trial's treatments could be effective for improving adherence to cancer risk management?

This trial will compare personalized outreach with web resources for cancer risk management. Studies have shown that personal outreach can significantly increase cancer screening rates. For instance, one study found a 42% rise in cervical screenings with this method. In this trial, participants in the personalized outreach arm will receive direct contact from a care coordinator. Personalized outreach has also enabled more high-risk patients to complete liver cancer screenings, ensuring more people receive the recommended tests.

Research on online resources, which participants in the web resources arm will receive, remains less clear but shows potential. Some studies suggest that online tools can help individuals better understand their family history of cancer, potentially leading to more screenings and early detection. However, further research is needed to confirm these benefits. ^{3 6 7 8 9}

Who Is on the Research Team?

Sarah Knerr, PhD, MPH

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

This trial is for individuals who have undergone genetic testing and are identified to be at risk of inherited cancer syndromes. It's open to those willing to engage with web resources and personalized outreach programs aimed at improving their health management.

Inclusion Criteria

I meet the age and sex requirements for my condition's risk management guidelines.

Remains eligible for risk management, given personal cancer and surgical history

My cancer has a genetic mutation that can be targeted for treatment.

Exclusion Criteria

I am currently receiving hospice or palliative care.

I have advanced dementia or severe cognitive issues.

I have previously declined to participate in genetic research.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive either personalized outreach or web resources to improve adherence to recommended cancer screening

12 months

Monthly contact attempts

Follow-up

Participants are monitored for adherence to recommended cancer screening and risk-reducing surgery

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Personalized outreach
• Web resources

Trial Overview The study tests two interventions: online educational materials (web resources) and direct, tailored communication (personalized outreach). The goal is to see if these methods help people follow recommended health practices after learning they're at risk for hereditary cancers.

How Is the Trial Designed?

Group I: Web resources Experimental Treatment 1 Intervention

Individuals randomized to web resources will be sent materials refined in Aim 1 (via patient portal and USPS mail) within 1-2 weeks after their birthday. Messages will be sent in English or preferred language noted in the EHR.

Group II: Personalized outreach Experimental Treatment 1 Intervention

Individuals randomized to personalized outreach will be contacted by the care coordinator in their birthday month for a brief phone call discussing due and overdue screening. The coordinator will attempt to contact patients up to 3 times to complete the phone conversation before considering them opting out of the intervention. If needed, the coordinator can place orders and pending referrals for PCP signature.

Group III: Usual care Active Control 1 Intervention

No intervention

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

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/PMC12153609/

Organizational Determinants, Outcomes Related to ... The intervention, targeting multiple types of cancer, reported a 42% absolute increase in cervical screening and comparable gains in breast ...

2. news.iastate.edu news.iastate.edu/news/personalized-cancer-outreach-more-effective-study-finds

Personalized cancer outreach more effective, study finds Lee's research shows a more personalized approach improves the completion rate of recommended screenings for patients at high risk for liver cancer.

3. ascopubs.org ascopubs.org/doi/10.1200/JCO.2021.39.15_suppl.e13524

Efficacy of a clinical risk prediction tool to prioritize ... Results: Results are described in table 1. Average ACU per patient was higher in Periods 1 and 2 for both Case Groups, compared to both Control ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10557878/

Risk management actions following genetic testing in the ... We describe use of risk management interventions following genetic testing in the Cancer Health Assessment Reaching Many (CHARM) study.

5. sciencedirect.com sciencedirect.com/science/article/pii/S2773065424001263

Patient Perspectives on Personalized Risk Communication ... Qualitative interviews showed participants' understanding of their results, trust in polygenic risk scores, perception of risk for colorectal cancer, plans to ...

6. reporter.nih.gov reporter.nih.gov/search/lq4f10HAcUCcOPRc-gf7Aw/project-details/10674202

RePORT RePORTER - National Institutes of Health (NIH) | The proposed research refines and evaluates two highly scalable population management interventions, web resources and personalized outreach, designed to ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT07053813

Study Details | NCT07053813 | Applying Population ... Personalized outreach is a high-touch intervention that connects patients with a dedicated care manager to discuss risk management and provide ...

8. hspop.uw.edu hspop.uw.edu/research-project-aims-to-improve-care-after-cancer-genetic-testing/

Research project aims to improve care after cancer genetic ... The project will provide clinical champions with data to select and implement population management interventions that address critical gaps in ...

9. cancer.gov cancer.gov/publications/pdq/information-summaries/genetics/risk-assessment-hp-pdq

Cancer Genetics Risk Assessment and Counseling (PDQ®) Posttest genetic counseling helps patients understand their test results, including the medical implications for themselves and their relatives.