The Florida ASCENT Study

Not Applicable

Not yet recruiting

• Conditions: Cancer; Food Deprivation; Food Habits; Food Selection; Colorectal Cancer; Prostate Cancer; Lung Cancer; Breast Cancer; Gynecologic Cancer; Hematologic Cancer

• Registration Number: NCT07042243
• Lead Sponsor: University of Florida

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®

Detailed Description

This study aims to establish a clinical trial of 200 cancer patients at the UF Health and University of Miami Health Systems (100 in Phase 1 and 100 in Phase 2). UF Health will serve as the Coordinating Center for the study.

Building on My Wellness Check, an electronic health records (EHR)-based referral system developed at the University of Miami for symptom and practical needs screening in cancer patients. This study will integrate the platform with a network of patient navigators who can provide individualized support and connect survivors with relevant community resources to promote healthy eating under a program called MyCarePulse.

The main objective is to adapt, implement, and evaluate MyCarePulse and ASCENT patient navigator to overcome barriers to care among patients with colorectal, prostate, lung, breast, gynecologic, hematologic, and skin (including melanoma) cancers

This study will take place in two phases. Phase 1 will consist of implementation strategy and Phase 2 will consist of the intervention phase.

Phase 1 has two aims:

In Aim 1, we will test the hypothesis that the ASCENT intervention, delivered through the MyCarePulse Research Portal, is implemented as intended using community-engaged participatory design methods to refine multilevel approaches.

In Aim 2, we will build readiness for the implementation of the MyCarePulse Research Portal and ASCENT patient navigator using the Expert Recommendations for Implementing Change (ERIC) strategies.

Phase 2 has one aim:

In Aim 3, we will implement and evaluate MyCarePulse Research Portal and ASCENT patient navigator in a randomized trial.

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-09
• Study First Submitted QC: 2025-06-26
• Last Update Submitted: 2025-06-26
• Study First Posted: 2025-06-27
• Last Update Posted: 2025-06-27
• Study Start: 2025-08-01
• Primary Completion: 2027-08
• Study Completion: 2027-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Food security from Baseline using U.S. FSSM	6 months	Self-reported by patient using the US Food Security Module (US FSSM). The US FSSM consists of 18 questions for homes with children under the age of 18 years and 10 items for households without children, e.g., a query regarding the use of emergency foods from food banks, soup kitchens, or other organizations by household members within the past year. The overall food security status (full, marginal, low and very low) will be determined by the number of affirmative responses to those questions.
Change in Diet quality from Baseline using the ASA24 Dietary Recall Assessment and the Veggie Meter Instrument	6 months	Evaluated by the ASA24 dietary recall assessment and Veggie Meter Instrument. The ASA24 dietary recall collect information on calorie intake and nutrient density, and will be assessed using the Healthy Eating Index (HEI), 2015 version. The Veggie Meter Instrument will give a score from 0-800, and higher scores are associated with greater fruit and vegetable intake.
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	Self-reported by patient using the the Preferences and Self-Efficacy of Diet and Physical Activity Behaviors scale. The scale measures preferences and self-efficacy for four behaviors: fruit and vegetable intake, dietary fat intake, added sugar intake and physical activity. A sample question is "Did MyCarePulse make you confident to eat healthy snacks like a fruit or a vegetable when you are really hungry?"

Secondary Outcome Measures

Name	Time	Method
SDOH Barriers Resolution in Patient Participants using the AHC HRSN Screening Tool	Baseline and 6 months Post-Intervention	The resolution of SDOH Barriers will be calculated from pre/post patient-reported assessments using AHC HRSN Screening Tool. The 13-item Centers for Medicare, Medicaid Services Accountable Health Communities Health-Related Social Needs (AHC HRSN) Screening Tool64. The AHC HRSN Screening Tool covers multiple dimensions of patient wellness, including diet quality, physical fitness, social support, and mental health.
Change in Health-related quality of life from Baseline using the PROMIS-29 Profile	Baseline and 6 months post-Intervention	Determined by pre/post-intervention assessment using the Patient-Reported Outcomes Measurement Information System, PROMIS-29 Profile, to assess health-related quality of life98. The PROMIS-29 comprises 29 items that include anxiety, depression, fatigue, pain interference, sleep disturbance, physical function, and ability to participate in social roles and activities.
Change in Feasibility, acceptability, and appropriateness of the intervention using REST to measure the implementation outcomes of FIM, AIM, and IAM	Baseline and 6 months Post-Intervention	The implementation outcomes of FIM, AIM, and IAM will be measured using the Research Engagement Survey Tool (REST). Clinical staff will complete these measures prior to patient enrollment and at the end of the study. All individuals engaged in planning or delivery of the intervention will complete it to determine the level of community engagement. Descriptive analyses will be used to characterize responses.