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)
* General Self-Efficacy Scale (GSE)
* Complete the Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool a total of 4 times.
* 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, with a focus on, but not limited to, colorectal, prostate, lung, breast, gynecologic, hematologic, or skin (including melanoma) cancers.
. Self-reported ability to read and speak English.
. Able to provide informed consent.
Exclusion criteria
. ≤18 years old.
. Does not have a pathologically confirmed diagnosis of cancer.
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.
1This study seems to be focused on food security and diet quality rather than a new drug or treatment — could you explain how joining this study might fit alongside my current cancer treatment plan, and whether there's any reason it might not be appropriate for my specific cancer type?
2The trial is measuring changes in food security using something called the U.S. Food Security Survey Module — does this mean the study is particularly aimed at people who are struggling to afford or access food, and is that something relevant to my situation?
3Since this study is tracking dietary habits and self-efficacy around eating behaviors, what kinds of commitments would I be making in terms of diet recalls and assessments, and is the time and effort realistic given what I'm already managing with my cancer care?
4This trial is listed as 'Phase NA,' which suggests it's not testing a medical drug or device — so what's the potential benefit to me personally, versus the benefit of simply working with a registered dietitian or nutritionist outside of a research study?
5Could participation in this study conflict with or delay any standard nutritional support or dietary counseling I might otherwise receive as part of my cancer treatment?
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
. Currently receiving active cancer treatment (e.g., active chemotherapy, radiation therapy or stem cell transplant); patients on stable maintenance therapy are eligible (e.g., endocrine therapy, targeted therapy, or select immunotherapy).
. ≥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.