The Florida ASCENT Study

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Study Purpose

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®

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & 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 Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT07042243
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of Florida
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	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

Additional Details

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.

Arms & Interventions

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

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.

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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