The Florida ASCENT Study

July 21, 2026 updated by: University of Florida

The Florida Partnership for Adding Social Context to Address Cancer Survivorship Outcomes (Florida ASCENT)

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®

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 cancer.

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 Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32610
        • Recruiting
        • University of Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Participants receiving Standard care and MyCarePulse
Participants not receiving the ASCENT Patient Navigator intervention, but are still utilizing MyCarePulse for comparison purposes. This arm will be conducted in phase 2 of the study and will have 50 participants (25 per site).
Experimental: Participants receiving ASCENT Patient Navigator (PN) Intervention and MyCarePulse
Participants will be receiving the ASCENT Patient Navigator intervention, and the MyCarePulse tool will flag participants who need assistance. They will then be connected to an ASCENT Patient Navigator to get those needs assessed. This arm will be conducted in phase 2 of the study and will have 50 participants (25 per site).
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Food security from Baseline using U.S. FSSM
Time Frame: 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.
6 months
Change in Diet quality from Baseline using the ASA24 Dietary Recall Assessment and the Veggie Meter Instrument
Time Frame: 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.
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
Time Frame: 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?"
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SDOH Barriers Resolution in Patient Participants using the AHC HRSN Screening Tool
Time Frame: 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.
Baseline and 6 months Post-Intervention
Change in Health-related quality of life from Baseline using the PROMIS-29 Profile
Time Frame: 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.
Baseline and 6 months post-Intervention
Change in Feasibility, acceptability, and appropriateness of the intervention using REST to measure the implementation outcomes of FIM, AIM, and IAM
Time Frame: 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.
Baseline and 6 months Post-Intervention

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Organizational Readiness from Baseline using the MORE Questionnaire
Time Frame: Baseline and 6 months Post-Intervention
The Measures of Organizational Readiness for Patient Engagement (MORE)83 will reflect the implementation context. It will be delivered pre- and post-intervention to assess change in organizational readiness during the ERIC adaptations and post-implementation. Clinical staff and clinic leadership to will be recruited to complete measures at the completion of in-clinic data collection periods.
Baseline and 6 months Post-Intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Collaborators

University of Miami

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 5, 2025

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2027

Study Registration Dates

First Submitted

June 9, 2025

First Submitted That Met QC Criteria

June 26, 2025

First Posted (Actual)

June 27, 2025

Study Record Updates

Last Update Posted (Actual)

July 23, 2026

Last Update Submitted That Met QC Criteria

July 21, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB202500820
  • PRO00064441 (Other Grant/Funding Number: FL DEPT OF HLTH)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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