The Florida ASCENT Study

NCT07042243 | Recruiting

• 2 other identifiers: IRB202500820PRO00064441
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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®

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Change in Food security from Baseline using U.S. FSSM

  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

  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

  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 Outcomes (3)

• SDOH Barriers Resolution in Patient Participants using the AHC HRSN Screening Tool

  Baseline and 6 months Post-Intervention

• Change in Health-related quality of life from Baseline using the PROMIS-29 Profile

  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

  Baseline and 6 months Post-Intervention

Other Outcomes (1)

• Change in Organizational Readiness from Baseline using the MORE Questionnaire

  Baseline and 6 months Post-Intervention

Study Arms (2)

Participants receiving Standard care and MyCarePulse

NO INTERVENTION

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

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

Interventions

MyCarePulse and ASCENT PN 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.

Participants receiving ASCENT Patient Navigator (PN) Intervention and MyCarePulse

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years old.
• Pathologically confirmed diagnosis of colorectal, prostate, lung, breast, gynecologic, hematologic, or skin (including melanoma) cancer within the past 12 months.
• Self-reported ability to read and speak English.
• Able to provide informed consent.
• Participant must not be considered a "vulnerable population" (pregnant women, neonates, children etc.)

You may not qualify if:

• ≤18 years old.
• 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.
• Participant does not live within the state of Florida.
• \) 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.)
• ≥18 years old.
• Currently works as a physician, physician assistant, patient navigator and/or health system/administrative leader in UF and UM affiliated clinics.
• Self-reported ability to read and speak English or Spanish.
• Able to provide informed consent.
• Participant must not be considered a "vulnerable population" (pregnant women, neonates, children etc.)
• ≤ 18 years old.
• Does not currently works as a physician, physician assistant, patient navigator and/or health system/administrative leader in UF and UM affiliated clinics.
• Does not self-report having the ability to read and speak English.
• Not able to provide informed consent.
• Participant is considered a "vulnerable population" (pregnant women, neonates, children etc.)

Sponsors & Collaborators

• University of Florida: lead
• University of Miami: collaborator

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms; Feeding Behavior; Food Preferences; Colorectal Neoplasms; Prostatic Neoplasms; Lung Neoplasms; Breast Neoplasms; Hematologic Neoplasms; Skin Neoplasms; Melanoma; Malnutrition

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Nutrition Disorders; Nutritional and Metabolic Diseases

Central Study Contacts

Dejana Braithwaite, PhD, MSc

CONTACT

4152165093; dbraithwaite@surgery.ufl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Access to the randomization list will be given only to project staff not involved in participant screening and enrollment to ensure objectivity and blinding.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2025
• First Posted: June 27, 2025
• Study Start: December 5, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: February 20, 2026

Record last verified: 2025-06

Locations

US (1)