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The Florida ASCENT Study
NCT07042243 · University of Florida
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
The Florida Partnership for Adding Social Context to Address Cancer Survivorship Outcomes (Florida ASCENT)
About this study
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.
Eligibility 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.)
Study design
Enrollment target: 100 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2025-12-05
Estimated completion: 2027-08
Last updated: 2026-02-20
Interventions
Behavioral: MyCarePulse and ASCENT PN
Primary outcomes
- • Change in Food security from Baseline using U.S. FSSM (6 months)
- • Change in Diet quality from Baseline using the ASA24 Dietary Recall Assessment and the Veggie Meter Instrument (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 (6 months)
Sponsor
University of Florida · other
With: University of Miami
Contacts & investigators
ContactDejana Braithwaite, PhD, MSc · contact · dbraithwaite@surgery.ufl.edu · 4152165093
All locations (1)
University of FloridaRecruiting
Gainesville, Florida, United States