Recruiting

Virtual Community Health Educator for Diverse Cancer Clinical Trial Recruitment

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What is being tested

Internet-Based Intervention

+ Questionnaire Administration
+ Virtual Technology Intervention
Other
Who is being recruted

Hematopoietic and Lymphatic System Neoplasm

+ Malignant Solid Neoplasm
Over 18 Years
+9 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Services Research Study

Interventional
Study Start: May 2025

See protocol details

Summary

Principal SponsorMayo Clinic
Study ContactJoanna Serat
Last updated: August 17, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: May 20, 2025Actual date on which the first participant was enrolled.

This study is exploring how effective a virtual community health educator, or vCHE, can be in increasing the number of cancer patients and their caregivers who are referred to clinical trials. Many people from underrepresented and underserved communities do not participate enough in cancer clinical trials, leading to unequal benefits from new treatments. Traditional community health educators have helped in the past, but they can be expensive and hard to manage. vCHEs are digital, photo-realistic agents designed to offer personalized support and information in both English and Spanish. They can represent various genders and racial or ethnic backgrounds, which might help more diverse groups of people join cancer clinical trials. Participants in this study will interact with a vCHE, which serves as a digital guide providing tailored information and guidance about clinical trials. The study will monitor how well these virtual agents can encourage more diverse participation in cancer trials by offering culturally relevant support. While the study does not involve taking any medication or undergoing treatments, it focuses on improving access to clinical trials, which could lead to more equitable cancer care. Potential risks are minimal, and the benefits could include higher trial enrollment rates among diverse populations, leading to more inclusive cancer research.

Official TitlePrecision Clinical Trial Recruitment to Promote Cancer Health Equity Across Florida (Aims 2 & 3) 
Principal SponsorMayo Clinic
Study ContactJoanna Serat
Last updated: August 17, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
750 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Services Research Study
These studies look at how healthcare is delivered, managed, and organized. They aim to improve care quality, patient experience, and access to treatment.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Hematopoietic and Lymphatic System Neoplasm
Malignant Solid Neoplasm
Criteria
8 inclusion criteria required to participate
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

Show More Criteria

1 exclusion criteria prevent from participating
Self-reported: people who are currently or have been in a cancer clinical trial within the last 3 years

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
2 intervention groups 

are designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
Participants receive information about available cancer clinical trials via the ALEX Research Portal and vCHE over 20-30 minutes on study.
Group II
Active Comparator
Participants receive information about available cancer clinical trials via online text on study.
Study Objectives
Primary Objectives

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

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Recruiting
Mayo Clinic in FloridaJacksonville, United StatesSee the location
Recruiting
One Study Center