Breast Cancer, Cancer, Colorectal Cancer, Food Deprivation, Food Habits, Food Selection, Gynecologic Cancer, Hematologic Cancer, Lung Cancer, Melanoma, Nutritional Deficiency, Nutrition Poor, Prostate Cancer, Skin Cancer
Conditions
Keywords
Food Insecurity, Cancer, Food Access, Community-Informed Research, Nutritional Needs, Mixed-Methods
Brief summary
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®
Detailed description
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.
Interventions
BEHAVIORALMyCarePulse 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.
Sponsors
University of Florida
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)
Masking description
Access to the randomization list will be given only to project staff not involved in participant screening and enrollment to ensure objectivity and blinding.
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Food security from Baseline using U.S. FSSM | 6 months | 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 | 6 months | 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 | 6 months | 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?" |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SDOH Barriers Resolution in Patient Participants using the AHC HRSN Screening Tool | Baseline and 6 months Post-Intervention | 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 | Baseline and 6 months post-Intervention | 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 | Baseline and 6 months Post-Intervention | 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. |
Countries
United States
Contacts
CONTACTDejana Braithwaite, PhD, MSc
Outcome results
None listed