This clinical trial develops and tests an assessment tool (the Adding Social Context to Address Cancer Survivorship Outcomes [ASCENT] questionnaire) in combination with patient navigation for improving food security, diet quality, and other modifiable social risk factors for cancer patients. While there has been an increase in the implementation of screening for and communication about modifiable risk factors among cancer patients, there is still little research on the best way to deliver risk-targeted care. The ASCENT intervention includes a questionnaire designed to identify individuals at risk for food insecurity, poor diet quality, and malnutrition, and can trigger a streamlined referral process for at-risk patients, allowing patient navigators to connect them with appropriate community resources and support services. The ASCENT intervention may be effective at addressing modifiable risk factors, improving food security and diet quality, and creating digital connections among cancer patients.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07042243.
Locations matching your search criteria
United States
Florida
Gainesville
UF Health Cancer Institute - GainesvilleStatus: Active
Contact: Dejana Braithwaite
Phone: 352-294-5822
Miami
University of Miami Miller School of Medicine-Sylvester Cancer CenterStatus: Active
Contact: Tracy E Crane
PRIMARY OBJECTIVES:
I. To test the hypothesis that the ASCENT intervention, delivered through the MyCarePulse tool, is implemented as intended using community-engaged participatory design methods to refine multilevel approaches.
II. To build readiness for the implementation of the MyCarePulse tool and ASCENT patient navigation (PN) using the Expert Recommendations for Implementing Change (ERIC) strategies.
III. To implement and evaluate MyCarePulse tool and ASCENT PN in a randomized trial.
OUTLINE:
PHASE 1: Providers and community members complete an interview once on study and patients complete the ASCENT questionnaire, dietary recall assessment, interview, and skin reflection spectroscopy twice on study in support of intervention refinement.
PHASE 2: Patients are randomized to 1 of 2 arms.
ARM I: Patients complete the ASCENT questionnaire as part of the MyCarePulse tool at baseline, month 3, and month 6. Within 7-10 days of each assessment, patients receive patient navigation from the ASCENT patient navigator, who will connect patients with relevant resources based on their individual needs, including nutrition education and access to food pharmacies.
ARM II: Patients complete the ASCENT questionnaire as part of the MyCarePulse tool at baseline, month 3, and month 6 and continue receiving standard care, including services and resources that are already part of the patient's established care.
After completion of study intervention, patients are followed up at 6 months.
Trial PhaseNo phase specified
Trial Typehealth services research
Lead OrganizationUF Health Cancer Institute - Gainesville
Principal InvestigatorDejana Braithwaite
