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A Virtual Community Health Educator for Increasing Clinical Trial Referrals Among Cancer Patients and Their Caregivers

Precision Clinical Trial Recruitment to Promote Cancer Health Equity Across Florida (Aims 2 & 3)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07126496
Enrollment
2000
Registered
2025-08-17
Start date
2025-05-20
Completion date
2027-08-31
Last updated
2026-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm

Brief summary

This clinical trial studies how well a virtual community health educator (vCHE) works in increasing clinical trial referrals for patients with cancer and their caregivers. Low enrollment of underrepresented and underserved populations in cancer clinical trials has led to disparities in intervention development and implementation. One approach to recruiting diverse populations to cancer clinical trials is community health educators. However, community health educator interventions are costly and difficult to implement. vCHEs are photo-realistic virtual agents that provide personalized guidance and support to users. They are designed to mimic real-life community health workers, offering culturally and linguistically tailored information to users. They can communicate in English or Spanish and are available in diverse genders and racial/ethnic backgrounds. vCHEs may be able to increase the enrollment of diverse participants into cancer clinical trials.

Interventions

OTHERInternet-Based Intervention

Receive information via online text

OTHERQuestionnaire Administration

Ancillary studies

Receive information via ALEX Research Portal and vCHE

Sponsors

Mayo Clinic
Lead SponsorOTHER
National Cancer Institute (NCI)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Individuals Diagnosed with Cancer * 18 years or older * Must have received a cancer diagnosis at any point in your life * Able to understand English or Spanish * Care Partners * Must be a care partner (also known as caregiver, carer, supporter, helper, aide, assistant, companion, attendant, advocate, or family caregiver) of an adult who has received a cancer diagnosis * Must be actively involved in the decision-making process OR care of a person diagnosed with cancer * Must be 18 years or older

Exclusion criteria

* Self-reported: people who are currently or have been in a cancer clinical trial within the last 3 years

Design outcomes

Primary

MeasureTime frameDescription
Proportion of referrals to cancer clinical trials (CCTs)Up to 3 monthsAssessed by the number of referrals (patient self-referral or care partner referral) to an open cancer clinical trial (CCT).
Number of patient referrals sent by a healthcare provider by using the ALEX portalUp to 3 monthsAssessed by the number of referral sent by providers on a patient's behalf to a study coordinator for screening.

Countries

United States

Contacts

CONTACTEnhancing Technology & Communication in Healthcare (ETCH) Lab
ETCH@mayo.edu904-953-5375
CONTACTClinical Trials Referral Office
mayocliniccancerstudies@mayo.edu855-776-0015
PRINCIPAL_INVESTIGATORJanice L. Krieger, PhD

Mayo Clinic

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 12, 2026