Actively Recruiting
Led by Georgetown University · Updated on 2026-01-22
100
Participants Needed
1
Research Sites
52 weeks
Total Duration
This research aims to evaluate the effectiveness of a Telehealth Intervention (THI) in preventing oral complications related to cancer, improving oral health maintenance and oral health-related quality of life, and reducing systemic inflammation compared to usual care among cancer survivors. The study will include 100 cancer survivors, both during active treatment and post-treatment, to assess outcomes such as mucositis, gingival inflammation, tooth decay, and overall quality of life. Participants will be randomly assigned to one of two groups: the THI group or the usual care group. The THI group will participate in six monthly virtual sessions that focus on oral health education, self-efficacy, and goal-setting, supported by biweekly text messages. Usual care participants will receive general health-related text messages and a dental resource directory. All participants will undergo intraoral imaging, saliva and blood sample collection, and complete various questionnaires at baseline, 6, and 12 months. Throughout the study, participants will provide saliva and blood samples to measure inflammation markers and oral microbiome profiles. Researchers will collect survey data on health behaviors, quality of life, and clinical characteristics. Intraoral images will be reviewed by dental consultants to monitor oral health changes. The study will track outcomes at baseline, 6, and 12 months to compare oral and systemic health between the two groups and evaluate the impact of the telehealth intervention over time.
CONDITIONS
F.L.O.S.S. Project (Facilitated Lessons on Oral and Systemic Health in Survivors)
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants complete baseline intraoral imaging, saliva and blood sample collection, surveys, and anthropometric measurements before randomization.
1 baseline visit (in-person)
Duration - 6 months
Participants randomized to the THI arm engage in monthly 1-hour virtual telehealth sessions for 6 months, including oral health assessments and counseling. Participants receive biweekly text messages with supportive content.
Monthly virtual visits and biweekly text messages
Duration - 6 months
Participants in the Usual Care arm receive biweekly text messages on general health behaviors and a dental resource directory without additional intervention.
Biweekly text messages
Duration - 6 months
Participants in both arms complete repeat intraoral imaging, saliva and blood sample collection, surveys, and anthropometric measurements at 6, 9, and 12 months post-randomization to monitor oral and systemic health outcomes.
In-person visits at 6 and 12 months; virtual or in-person visit at 9 months
Total: 1 location
1
Georgetown Lombardi Office of Minority Health
Washington D.C., District of Columbia, United States, 20003
Actively Recruiting
S
Smith
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Chiranjeev Dash, Danyel I Smith, Naaria Williams...
https://pubmed.ncbi.nlm.nih.gov/41286997