Clinical trial · Interventional
The Florida ASCENT Study
The Florida Partnership for Adding Social Context to Address Cancer Survivorship Outcomes (Florida ASCENT)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (14)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Food Deprivation | — | UNRESOLVED | — |
| Food Habits | — | UNRESOLVED | — |
| Food Selection | — | UNRESOLVED | — |
| Gynecologic Cancer | Malignant Female Reproductive System Neoplasm | ALIAS | 0.90 |
| Hematologic Cancer | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MyCarePulse and ASCENT PN | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Participants receiving Standard care and MyCarePulse
- 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).
- type
- EXPERIMENTAL
- label
- Participants receiving ASCENT Patient Navigator (PN) Intervention and MyCarePulse
- 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).
- interventionNames
- Behavioral: MyCarePulse and ASCENT PN
Primary outcomes (3)
- measure
- Change in Food security from Baseline using U.S. FSSM
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available