This clinical trial evaluates the effectiveness of an educational telehealth intervention for preventing oral health complications and improving oral health outcomes in cancer survivors. Cancer survivors, due to chemotherapy and radiation treatment, have a higher risk of oral health complications such as mucositis or mouth irritation/inflammation. Telehealth has been shown to be effective in addressing healthcare needs outside of a traditional medical setting and increases access to healthcare services by reducing barriers (for example, transportation) for some patients. This telehealth intervention, which educates patients on oral health-related symptoms, oral hygiene, and oral health-related behavior changes, may help prevent the development of oral health complications like mucositis in cancer survivors.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06315855.
Locations matching your search criteria
United States
District of Columbia
Washington
MedStar Washington Hospital CenterStatus: Active
Contact: Ami Chitalia
MedStar Georgetown University HospitalStatus: Active
Contact: Chiranjeev Dash
Phone: 202-687-5367
PRIMARY OBJECTIVE:
I. To assess efficacy of a telehealth intervention (THI) in improving cancer-related oral complications (e.g., mucositis), oral health-related quality of life (ORHQoL), and other systemic markers compared to usual care (UC).
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients attend telehealth sessions where they receive education on oral and health related symptoms over 30 minutes each, weekly for 6 weeks, and attend booster sessions to review fundamentals of self-regulation and behavior change and oral hygiene takeaways at 3 and 6 months. Patients also receive educational text messages promoting oral hygiene related to the telehealth session content biweekly, and receive printed and electronic educational materials, tools, resources, and instructions for oral health maintenance on study. Patients also undergo collection of blood samples and dual x-ray absorptiometry (DEXA) throughout the study.
ARM II: Patients receive text messages on general healthy habits biweekly for 6 months. Patients also undergo collection of blood samples and DEXA throughout the study.
After completion of study intervention, patients are followed up in months 6 and 12.
Trial PhaseNo phase specified
Trial Typeprevention
Lead OrganizationMedStar Georgetown University Hospital
Principal InvestigatorChiranjeev Dash
