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The Florida ASCENT Study

NCT07042243 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-02-20

No results posted yet for this study

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®

Conditions

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.

Sponsors & Collaborators

  • University of Miami

    collaborator OTHER

  • University of Florida

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-05
Primary Completion
2027-08-31
Completion
2027-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07042243 on ClinicalTrials.gov