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

NCT ID: NCT07126496

Last Updated: 2026-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

750 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-20

Study Completion Date

2027-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hematopoietic and Lymphatic System Neoplasm Malignant Solid Neoplasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Arm I (ALEX Research Portal, vCHE)

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

Group Type EXPERIMENTAL

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Virtual Technology Intervention

Intervention Type OTHER

Receive information via ALEX Research Portal and vCHE

Arm II (online text)

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

Group Type ACTIVE_COMPARATOR

Internet-Based Intervention

Intervention Type OTHER

Receive information via online text

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Internet-Based Intervention

Receive information via online text

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Virtual Technology Intervention

Receive information via ALEX Research Portal and vCHE

Intervention Type OTHER

Other Intervention Names

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Virtual Reality Intervention Virtual Technology

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janice L. Krieger, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Florida

Jacksonville, Florida, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Enhancing Technology & Communication in Healthcare (ETCH) Lab

Role: CONTACT

904-953-5375

Clinical Trials Referral Office

Role: CONTACT

855-776-0015

Facility Contacts

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ETCH Lab

Role: primary

904-953-5375

Clinical Trials Referral Office

Role: backup

855-776-0015

Related Links

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Other Identifiers

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NCI-2025-05254

Identifier Type: REGISTRY

Identifier Source: secondary_id

23-013379

Identifier Type: OTHER

Identifier Source: secondary_id

U01CA274970

Identifier Type: NIH

Identifier Source: secondary_id

View Link

23-013379

Identifier Type: -

Identifier Source: org_study_id

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