Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| PRO00064441 | Other Grant/Funding Number | FL DEPT OF HLTH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Miami | OTHER |
Not provided
Not provided
Not provided
Not provided
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:
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:
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:
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants receiving Standard care and MyCarePulse | No Intervention | 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). | |
| Participants receiving ASCENT Patient Navigator (PN) Intervention and MyCarePulse | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MyCarePulse and ASCENT PN | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| 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. | 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 | 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?" | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Patient Eligibility Inclusion Criteria:
Patient Eligibility Exclusion Criteria:
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
Provider Eligibility Exclusion Criteria
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dejana Braithwaite, PhD, MSc | Contact | 4152165093 | dbraithwaite@surgery.ufl.edu |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Recruiting | Gainesville | Florida | 32610 | United States |
Not provided
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D005247 | Feeding Behavior |
| D005518 | Food Preferences |
| D015179 | Colorectal Neoplasms |
| D011471 | Prostatic Neoplasms |
| D008175 | Lung Neoplasms |
| D001943 | Breast Neoplasms |
| D019337 | Hematologic Neoplasms |
| D012878 | Skin Neoplasms |
| D008545 | Melanoma |
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D001522 | Behavior, Animal |
| D001519 | Behavior |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Access to the randomization list will be given only to project staff not involved in participant screening and enrollment to ensure objectivity and blinding.
|
| Baseline and 6 months Post-Intervention |
| 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. | 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 | 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. | Baseline and 6 months Post-Intervention |
| Baseline and 6 months Post-Intervention |
| D004067 |
| Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |