| NCT ID | NCT07042243 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Florida |
| Condition | Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-12-05 |
| Primary Completion | 2027-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2025-12-05 with a primary completion date of 2027-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to adapt, implement, and evaluate MyCarePulse and ASCENT patient navigator to overcome barriers to care among patients with cancer. The main hypotheses it aims to test are: * At the patient level, the intervention will result in higher levels of food security, self- efficacy for dietary behaviors, and higher diet quality than standard care. * At the provider level, the intervention will be feasible, acceptable, appropriate, and able to enhance individualized care for patient wellness. Researchers will compare cancer patients receiving the MyCarePulse and ASCENT patient navigator intervention to those receiving standard care, to see if the intervention improves food security, self-efficacy, and diet quality. Phase 1 Patient Participants will: * Complete the ASCENT Questionnaire, which is comprised of the following: * U.S. Food Security Survey Module (U.S. FSSM) * Patient-Reported Outcomes Measurement Information System (PROMIS-29) * Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool * Be assessed using the Veggie Meter instrument * Participate in two semi-structured interviews Provider Participants will: •Participate in one semi-structured interview Phase 2 Patient Participants will: * Participate in ASCENT patient navigator screenings and consultations * Complete the ASCENT Questionnaire, which comprises the U.S. FSSM, PROMIS-29, and ASA24®
Eligibility Criteria
Patient Eligibility Inclusion Criteria: 1. ≥18 years old. 2. Pathologically confirmed diagnosis of colorectal, prostate, lung, breast, gynecologic, hematologic, or skin (including melanoma) cancer within the past 12 months. 3. Self-reported ability to read and speak English. 4. Able to provide informed consent. 5. Participant must not be considered a "vulnerable population" (pregnant women, neonates, children etc.) Patient Eligibility Exclusion Criteria: 1. ≤18 years old. 2. Participant do not have a pathologically confirmed diagnosis of colorectal, prostate, lung, breast, gynecologic, hematologic, or skin (including melanoma) cancer within the past 12 months. 3. Participant does not live within the state of Florida. 3\) Does not self-reported ability to read and speak English or Spanish. 4) Not able to provide informed consent. 5) Participant is considered a "vulnerable population" (pregnant women, neonates, children etc.) Provider Eligibility Inclusion Criteria 1. ≥18 years old. 2. Currently works as a physician, physician assistant, patient navigator and/or health system/administrative leader in UF and UM affiliated clinics. 3. Self-reported ability to read and speak English or Spanish. 4. Able to provide informed consent. 5. Participant must not be considered a "vulnerable population" (pregnant women, neonates, children etc.) Provider Eligibility Exclusion Criteria 1. ≤ 18 years old. 2. Does not currently works as a physician, physician assistant, patient navigator and/or health system/administrative leader in UF and UM affiliated clinics. 3. Does not self-report having the ability to read and speak English. 4. Not able to provide informed consent. 5. Participant is considered a "vulnerable population" (pregnant women, neonates, children etc.)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07042243 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07042243 currently recruiting?
Yes, NCT07042243 is actively recruiting participants. Contact the research team at dbraithwaite@surgery.ufl.edu for enrollment information.
Where is the NCT07042243 trial being conducted?
This trial is being conducted at Gainesville, United States.
Who is sponsoring the NCT07042243 clinical trial?
NCT07042243 is sponsored by University of Florida. The trial plans to enroll 100 participants.
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