Hematopoietic and Lymphatic System NeoplasmNCT07126496
A Virtual Community Health Educator for Increasing Clinical Trial Referrals Among Cancer Patients and Their Caregivers
A study testing Internet-Based Intervention, Questionnaire Administration and Virtual Technology Intervention in people with Hematopoietic and Lymphatic System Neoplasm and Malignant Solid Neoplasm, run by Mayo Clinic at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
- What is being tested?
- Internet-Based Intervention, Questionnaire Administration and Virtual Technology Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteUnited States
- Study dates
- 20 May 2025to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Self-reported: people who are currently or have been in a cancer clinical trial within the last 3 years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
ETCH Lab, 904-953-5375, ETCH@mayo.edu
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
About this study
Official title: Precision Clinical Trial Recruitment to Promote Cancer Health Equity Across Florida (Aims 2 & 3)
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.
- Being tested
- Internet-Based Intervention, Questionnaire Administration, Virtual Technology Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-Based InterventionOther
Receive information via online text
Questionnaire AdministrationOther
Ancillary studies
Virtual Technology InterventionOther
Also called Virtual Reality Intervention, Virtual Technology
Receive information via ALEX Research Portal and vCHE
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Questionnaire Administration; Other: Virtual Technology Intervention |
| Arm II (online text) | Active comparator | Participants receive information about available cancer clinical trials via online text on study. Receives: Other: Internet-Based Intervention; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2025
- Study start20 May 2025
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic and Lymphatic System NeoplasmStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Janice L. Krieger, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07126496
- Sponsor's protocol ID
- 23-013379
- Other IDs
- NCI-2025-05254, 23-013379, U01CA274970
- Status last verified
- Aug 2026
- First submitted
- 11 Aug 2025
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision Clinical Trial Recruitment to Promote Cancer Health Equity Across Florida (Aims 2 & 3)
- ClinicalTrials.gov ID
- NCT07126496
- Acronym / sponsor ID
- 23-013379
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 20 May 2025 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 17 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (ALEX Research Portal, vCHE) | Experimental | Other: Questionnaire Administration, Other: Virtual Technology InterventionParticipants receive information about available cancer clinical trials via the ALEX Research Portal and vCHE over 20-30 minutes on study. |
| Arm II (online text) | Active comparator | Other: Internet-Based Intervention, Other: Questionnaire AdministrationParticipants receive information about available cancer clinical trials via online text on study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Individuals Diagnosed with Cancer
- Care Partners
Key exclusion criteria (1 listed)
- Self-reported: people who are currently or have been in a cancer clinical trial within the last 3 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet-Based InterventionReceive information via online text | Other | Arm II (online text) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (ALEX Research Portal, vCHE), Arm II (online text) |
| Virtual Technology InterventionAlso: Virtual Reality Intervention, Virtual TechnologyReceive information via ALEX Research Portal and vCHE | Other | Arm I (ALEX Research Portal, vCHE) |
Primary outcome
Proportion of referrals to cancer clinical trials (CCTs)
Time frame: Up to 3 months
Assessed 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 portal
Time frame: Up to 3 months
Assessed by the number of referral sent by providers on a patient's behalf to a study coordinator for screening.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Janice L. Krieger, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-Based Intervention, Questionnaire Administration and Virtual Technology Intervention in people with Hematopoietic and Lymphatic System Neoplasm and Malignant Solid Neoplasm, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Enhancing Technology & Communication in Healthcare (ETCH) Lab (904-953-5375, ETCH@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of referrals to cancer clinical trials (CCTs) (time frame: Up to 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.