The Florida ASCENT Study

NCT ID: NCT07042243

Last Updated: 2025-11-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2027-08-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

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).

Group Type: EXPERIMENTAL

MyCarePulse and ASCENT PN

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.)

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.)

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.)

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.)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Miami

OTHER

Sponsor Role: collaborator

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Florida

Gainesville, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Dejana Braithwaite, PhD, MSc

Role: CONTACT

dbraithwaite@surgery.ufl.edu

4152165093

Other Identifiers

PRO00064441

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRB202500820

Identifier Type: -

Identifier Source: org_study_id