Recruiting

The Florida ASCENT Study

ClinicalTrials.gov IDNCT07042243

PhaseNA

Enrollment100

SponsorUniversity of Florida

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Cancer, Food Deprivation, Food Habits, Food Selection, Colorectal Cancer, Prostate Cancer, Lung Cancer, Breast Cancer, Gynecologic Cancer, Hematologic Cancer, Skin Cancer, Melanoma, Nutrition Poor, Nutritional Deficiency

About this study

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®

Interventions

Behavioral: MyCarePulse and ASCENT PN — The combination of a digital platform and patient navigators assisting the process. Also, taking a multi-level approach engaging community members, patients, and providers in phase one through qualitative interviews. Then using the findings to adapt MyCarePulse for the clincial trial in phase two.

Primary outcomes

Change in Food security from Baseline using U.S. FSSM (6 months)
Change in Diet quality from Baseline using the ASA24 Dietary Recall Assessment and the Veggie Meter Instrument (6 months)
Change in Self efficacy for dietary behaviors from Baseline using the the Preferences and Self-Efficacy of Diet and Physical Activity Behaviors Scale (6 months)

Eligibility information

Patient Eligibility Inclusion Criteria: 1. ≥18 years old. 2. Pathologically confirmed diagnosis, with a focus on, but not limited to, colorectal, prostate, lung, breast, gynecologic, hematologic, or skin (including melanoma) cancers. 3. Self-reported ability to read and speak English. 4. Able to provide informed consent. Patient Eligibility Exclusion Criteria: 1. ≤18 years old. 2. Does not have a pathologically confirmed diagnosis of cancer. 3. 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). 3\) 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. 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. 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.

Study locations

University of Florida, Gainesville, Florida 32610 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.