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

Mayo Clinic

Status: Enrolling

Conditions: Hematopoietic and Lymphatic System Neoplasm; Malignant Solid Neoplasm

Treatments: Other: Internet-Based Intervention; Other: Virtual Technology Intervention; Other: Questionnaire Administration

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07126496

23-013379 (Other Identifier)

NCI-2025-05254 (Registry Identifier)

U01CA274970 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 750 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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750 participants in 2 patient groups

Arm I (ALEX Research Portal, vCHE)

Experimental group

Description:

Participants receive information about available cancer clinical trials via the ALEX Research Portal and vCHE over 20-30 minutes on study.

Treatment:

Other: Questionnaire Administration

Other: Virtual Technology Intervention

Arm II (online text)

Active Comparator group

Description:

Participants receive information about available cancer clinical trials via online text on study.

Treatment:

Other: Questionnaire Administration

Other: Internet-Based Intervention