The Florida ASCENT Study

University of Florida

Status: Enrolling

Conditions: Breast Cancer; Melanoma; Hematologic Cancer; Lung Cancer; Food Habits; Cancer; Food Selection; Skin Cancer; Gynecologic Cancer; Nutritional Deficiency; Food Deprivation; Prostate Cancer; Nutrition Poor; Colorectal Cancer

Treatments: Behavioral: MyCarePulse and ASCENT PN

Study type: Interventional

Funder types: Other

Identifiers

NCT07042243

IRB202500820

PRO00064441 (Other Grant/Funding Number)

Details and patient eligibility

About

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®

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Patient Eligibility 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.)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Participants receiving Standard care and MyCarePulse

No Intervention group

Description:

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).

Participants receiving ASCENT Patient Navigator (PN) Intervention and MyCarePulse

Experimental group

Description:

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).

Treatment:

Behavioral: MyCarePulse and ASCENT PN