Recruiting

MyCarePulse & ASCENT

Sponsor:

University of Florida

Code:

NCT07042243

Conditions

Cancer

Food Deprivation

Food Habits

Food Selection

Colorectal Cancer

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

MyCarePulse and ASCENT PN

Study Details

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)
  • 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®

Conditions

Cancer

Food Deprivation

Food Habits

Food Selection

Colorectal Cancer

Study ID

NCT07042243

Start date

Dec 5, 2025

Status verified date

Jul, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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).

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.

Primary outcome measure

  • Change in Food security from Baseline using U.S. FSSM [ Time Frame: 6 months ]
  • Change in Diet quality from Baseline using the ASA24 Dietary Recall Assessment and the Veggie Meter Instrument [ Time Frame: 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 ]

Central Contacts and Locations

Central contacts

Dejana Braithwaite, PhD, MSc

4152165093dbraithwaite@surgery.ufl.edu

Locations

University of Florida

Recruiting

Gainesville, Florida, United States, 32610

More Information

Sponsor

University of Florida

Last update posted

Jul 23, 2026

Last verified

Jul, 2026

Keywords

  • Food Insecurity
  • Cancer
  • Food Access
  • Community-Informed Research
  • Nutritional Needs
  • Mixed-Methods

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-27. This information was provided to ClinicalTrials.gov by University of Florida on 2026-07-23. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.