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®
≥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.
≤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).
≥18 years old.
Parallel
MyCarePulse and ASCENT PN
BehavioralThe 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.
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.
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.
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?"
SDOH Barriers Resolution in Patient Participants using the AHC HRSN Screening Tool
The resolution of SDOH Barriers will be calculated from pre/post patient-reported assessments using AHC HRSN Screening Tool. The 13-item Centers for Medicare, Medicaid Services Accountable Health Communities Health-Related Social Needs (AHC HRSN) Screening Tool64. The AHC HRSN Screening Tool covers multiple dimensions of patient wellness, including diet quality, physical fitness, social support, and mental health.
Change in Health-related quality of life from Baseline using the PROMIS-29 Profile
Determined by pre/post-intervention assessment using the Patient-Reported Outcomes Measurement Information System, PROMIS-29 Profile, to assess health-related quality of life98. The PROMIS-29 comprises 29 items that include anxiety, depression, fatigue, pain interference, sleep disturbance, physical function, and ability to participate in social roles and activities.
Change in Feasibility, acceptability, and appropriateness of the intervention using REST to measure the implementation outcomes of FIM, AIM, and IAM
The implementation outcomes of FIM, AIM, and IAM will be measured using the Research Engagement Survey Tool (REST). Clinical staff will complete these measures prior to patient enrollment and at the end of the study. All individuals engaged in planning or delivery of the intervention will complete it to determine the level of community engagement. Descriptive analyses will be used to characterize responses.
Change in Organizational Readiness from Baseline using the MORE Questionnaire
The Measures of Organizational Readiness for Patient Engagement (MORE)83 will reflect the implementation context. It will be delivered pre- and post-intervention to assess change in organizational readiness during the ERIC adaptations and post-implementation. Clinical staff and clinic leadership to will be recruited to complete measures at the completion of in-clinic data collection periods.
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University of Florida
Lead sponsor
University of Miami
Collaborator
