NCT07126496

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for not_applicable

Timeline
16mo left

Started May 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress42%
May 2025Aug 2027

Study Start

First participant enrolled

May 20, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 11, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 17, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2027

Last Updated

February 23, 2026

Status Verified

February 1, 2026

Enrollment Period

2.3 years

First QC Date

August 11, 2025

Last Update Submit

February 19, 2026

Conditions

Malignant Solid NeoplasmHematopoietic and Lymphatic System Neoplasm

Outcome Measures

Primary Outcomes (2)

  • Proportion of referrals to cancer clinical trials (CCTs)

    Assessed by the number of referrals (patient self-referral or care partner referral) to an open cancer clinical trial (CCT).

    Up to 3 months

  • Number of patient referrals sent by a healthcare provider by using the ALEX portal

    Assessed by the number of referral sent by providers on a patient's behalf to a study coordinator for screening.

    Up to 3 months

Study Arms (2)

Arm I (ALEX Research Portal, vCHE)

EXPERIMENTAL

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

Other: Questionnaire AdministrationOther: Virtual Technology Intervention

Arm II (online text)

ACTIVE COMPARATOR

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

Other: Internet-Based InterventionOther: Questionnaire Administration

Interventions

Internet-Based InterventionOTHER

Receive information via online text

Arm II (online text)
Questionnaire AdministrationOTHER

Ancillary studies

Arm I (ALEX Research Portal, vCHE)Arm II (online text)
Virtual Technology InterventionOTHER

Receive information via ALEX Research Portal and vCHE

Also known as: Virtual Reality Intervention, Virtual Technology
Arm I (ALEX Research Portal, vCHE)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals Diagnosed with Cancer
  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

RECRUITING

Related Links

Study Officials

  • Janice L. Krieger, PhD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Enhancing Technology & Communication in Healthcare (ETCH) Lab

CONTACT

904-953-5375ETCH@mayo.edu

Clinical Trials Referral Office

CONTACT

855-776-0015mayocliniccancerstudies@mayo.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2025

First Posted

August 17, 2025

Study Start

May 20, 2025

Primary Completion (Estimated)

August 31, 2027

Study Completion (Estimated)

August 31, 2027

Last Updated

February 23, 2026

Record last verified: 2026-02

Locations

US(1)