This clinical trial tests how well a preventative care intervention works to improve weight management, cancer screenings and mental health in economically disadvantaged populations. There is a recognized and continued need for medical interventions to address health inequities in economically disadvantaged populations. By providing care coordination via team based approaches patients can be linked with community based services focused on evidence-based preventive services that improve obesity, mental health, and cancer prevention outcomes.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07091032.
Locations matching your search criteria
United States
Massachusetts
Boston
Massachusetts General Hospital Cancer CenterStatus: Active
Contact: Margarita Alegria
PRIMARY OBJECTIVE:
I. Evaluate the effectiveness of the obesity, mental health, and cancer prevention services, and if effective, launch and facilitate learning communities to disseminate the coaching and support model to other Medicaid/Accountable Care Organization (ACO) practices in year (Y)5.
OUTLINE: In year 1 participants are assigned to cohort 1, in year 2 patients are assigned to cohort 2.
COHORT 1: Patients receive usual care, complete an interview and have their medical records reviewed on study.
COHORT 2: Patients are assigned to at least 1 intervention. Patients qualifying for multiple interventions may participate in all applicable interventions or may select one based on interest.
OBESITY: Patients receive lifestyle coaching sessions from a community health worker including education about diet, support on nutrition planning and cooking and tailored diet and exercise advice, over 6 sessions. Patients may also receive education regarding anti-obesity medication and support for medication adherence and to follow up on obesity related referrals.
CANCER PREVENTION: Patients receive written education regarding colorectal and cervical cancer screening and screening options available to them. Patients due for colorectal cancer screening then have either a fecal immunochemical test (FIT), FIT-deoxyribonucleic acid (DNA) test, colonoscopy, or Shield blood tests ordered for them. Patients due for cervical cancer screening have clinic staff/Community Health Workers initiate collection of HPV self-sampling and/or are provided a FIT kit or an order for FIT-DNA testing. Patients receive motivational text messages to remind them to return FIT kits and/or to keep clinic screening appointments. Patients receive assistance via a patient navigator to receive results and coordinate any needed follow up.
MENTAL HEALTH: Patients receive mental health sessions from a community health worker including motivational interviewing, mindfulness, behavioral activation, psychoeducation, and self-management elements, for up to 10 group or individual sessions up to 6 months.
After completion of study intervention, patients are followed up at 6 and 12 months from enrollment.
Trial PhaseNo phase specified
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationDana-Farber Harvard Cancer Center
Principal InvestigatorMargarita Alegria
