Study of Telehealth Intervention to Improve Oral and Systemic Health in Cancer Survivors Aged 25 to 75
Led by Georgetown University · Updated on 2026-01-22
100
Participants Needed
1
Research Sites
52 weeks
Total Duration
AI-Summary
What this Trial Is About
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
Brief Title
F.L.O.S.S. Project (Facilitated Lessons on Oral and Systemic Health in Survivors)
Research Team
S
Smith
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This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
Factors
THI (Telehealth Education)
Usual Care (UC)
Guideline Basic Oral Care
What it is
A six‑month telehealth sessions programme for cancer survivors to guide oral health maintenance, mucositis management, diet and lifestyle, and follow‑up assessments.
Standard or routine post‑treatment care without structured telehealth oral health guidance.
Guideline‑recommended basic oral hygiene (e.g. regular gentle tooth brushing and oral care protocols) to help prevent and manage mucositis.
Role in trial
Experimental behavioural intervention delivered via monthly telehealth sessions.
Control arm providing standard follow‑up without added telehealth support.
Represents accepted prevention approach outside the trial setting.
Primary use
Support oral health maintenance and reduce mucositis and systemic inflammation in post‑treatment cancer survivors.
Routine post‑treatment monitoring without targeted oral health counselling.
Basic oral hygiene to help prevent oral complications like mucositis during or after cancer therapy.
How it is given or performed
Delivered via monthly telehealth (video or phone) sessions over six months with oral health guidance and post‑intervention follow‑up at 6, 9 and 12 months.
No structured delivery; participants follow routine care pathways.
Per guidelines, involves regular gentle oral hygiene routines such as brushing with a soft toothbrush and following basic care protocols.
Evidence status
Effectiveness is being evaluated in this RCT; results not yet available.
Represents current monitoring with uncertain impact on oral or systemic outcomes in this population.
Basic oral care has guideline‑supported benefits in preventing mucositis in broader cancer patient populations.
Important limitations
Effectiveness unknown until trial results are available; requires smartphone access and adherence to telehealth sessions.
Lacks structured support; may not address oral health needs proactively.
Guideline‑recommended basic care may not be implemented consistently by survivors outside supervised settings.
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
Who Can Participate
Age: 25Years - 75Years
All Genders
Eligibility Criteria
You may qualify if you...
Male and female cancer survivors who are at least 6 months after completing primary cancer treatment
Between 25 and 75 years of age
All race and ethnic groups
Own a smartphone
You will not qualify if you...
Survivors of head and neck or oral cancer
Younger than 25 years or older than 75 years
Recurrence or second cancers or currently undergoing cancer treatment
Unable to provide informed consent
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Baseline Assessment
Duration - 1 day
Participants complete baseline intraoral imaging, saliva and blood sample collection, surveys, and anthropometric measurements before randomization.
1 baseline visit (in-person)
Telehealth Intervention (THI)
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
Usual Care Observation
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
Follow-up Assessments
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Published Research Related To This Trial
The FLOSS Project: study protocol for a parallel-group, two-arm randomized controlled trial examining the efficacy of telehealth in promoting oral and systemic health in cancer survivors.
Chiranjeev Dash, Danyel I Smith, Naaria Williams...