The Florida ASCENT Study (NCT07042243) | Clinical Trial Compass
RecruitingNot Applicable
The Florida ASCENT Study
United States100 participantsStarted 2025-12-05
Plain-language 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®
Who can participate
Age range
18 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. ≥18 years old.
. Pathologically confirmed diagnosis of colorectal, prostate, lung, breast, gynecologic, hematologic, or skin (including melanoma) cancer within the past 12 months.
. Self-reported ability to read and speak English.
. Able to provide informed consent.
. Participant must not be considered a "vulnerable population" (pregnant women, neonates, children etc.)
Exclusion criteria
. ≤18 years old.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Food security from Baseline using U.S. FSSM
Timeframe: 6 months
2
Change in Diet quality from Baseline using the ASA24 Dietary Recall Assessment and the Veggie Meter Instrument
Timeframe: 6 months
3
Change in Self efficacy for dietary behaviors from Baseline using the the Preferences and Self-Efficacy of Diet and Physical Activity Behaviors Scale
. 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.
. Participant does not live within the state of Florida.
. ≥18 years old.
. Currently works as a physician, physician assistant, patient navigator and/or health system/administrative leader in UF and UM affiliated clinics.
. Self-reported ability to read and speak English or Spanish.
. Able to provide informed consent.
. Participant must not be considered a "vulnerable population" (pregnant women, neonates, children etc.)