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F.L.O.S.S. Project (Facilitated Lessons on Oral and Systemic Health in Survivors)

NCT06315855 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-01-22

No results posted yet for this study

Summary

The investigators will conduct a 2-arm 6-month randomized clinical controlled trial to evaluate the effectiveness of an oral Telehealth Intervention (THI) in preventing cancer-related oral complications, improving oral health maintenance and oral health related quality of life, and reducing systemic inflammation compared to Usual Care (UC) among unselected cancer survivors.

Conditions

  • Oral Mucositis
  • Periodontal Diseases
  • Cancer

Interventions

BEHAVIORAL

Telehealth Intervention (THI)

The THI is a 6-month intervention. On a monthly basis, the survivor will be queried via telehealth (zoom or smart phone) oral and health related symptoms by nurse practitioner or navigator. Based on the initial imaging and the monthly assessments, the patients will be provided with tools and instructions for oral health maintenance which may consist of mucositis management and/or diet and lifestyle counseling. All participants will be provided a Resource directory that is to be used to identify a dentist that is best suited for him/her. Post intervention, follow-up assessments will be conducted at 6-, 9- and 12-months post randomization.

Sponsors & Collaborators

  • Georgetown University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-20
Primary Completion
2026-08-25
Completion
2027-08-25

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06315855 on ClinicalTrials.gov