The Florida ASCENT Study

Официальное название

The Florida Partnership for Adding Social Context to Address Cancer Survivorship Outcomes (Florida ASCENT)

Обзор

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®

Подробное описание

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 cancer.

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.

Вмешательства

• Поведенческое 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.

Первичные конечные точки

• Change in Food security from Baseline using U.S. FSSM [Срок оценки: 6 months]
• Change in Diet quality from Baseline using the ASA24 Dietary Recall Assessment and the Veggie Meter Instrument [Срок оценки: 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 [Срок оценки: 6 months]

Вторичные конечные точки (3)

• SDOH Barriers Resolution in Patient Participants using the AHC HRSN Screening Tool [Срок оценки: Baseline and 6 months Post-Intervention]
• Change in Health-related quality of life from Baseline using the PROMIS-29 Profile [Срок оценки: 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 [Срок оценки: Baseline and 6 months Post-Intervention]

Критерии участия

Patient Eligibility Inclusion Criteria:

• ≥18 years old.
• Pathologically confirmed diagnosis, with a focus on, but not limited to, colorectal, prostate, lung, breast, gynecologic, hematologic, or skin (including melanoma) cancers.
• Self-reported ability to read and speak English.
• Able to provide informed consent.

Patient Eligibility Exclusion Criteria:

• ≤18 years old.
• Does not have a pathologically confirmed diagnosis of cancer.
• 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

• ≥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.

Provider Eligibility Exclusion Criteria

• ≤ 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• University of Florida — Gainesville

Идентификаторы

NCT: NCT07042243 · IRB202500820 · PRO00064441

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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