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

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Georgetown University
Study ID
NCT06315855
Status
Recruiting
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Conditions

  • Cancer
  • Oral Mucositis
  • Periodontal Diseases

Eligibility Criteria

Sex
ALL
Age
25 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Telehealth Intervention (THI) — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Aug 20, 2024
Status verified
Jan 2026
Primary completion
Aug 25, 2026
Completion
Aug 25, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Telehealth Intervention (THI) arm
    The THI is a 6-month intervention. Participants randomized to THI arm will engage in 6,1-hour virtual sessions with trained study personnel. Modules contain a 1) participant check-in, 2) content designed to build oral health literacy and self-efficacy, 3) and goal-setting. Coaches will use a facilitation guide, layered with motivational interviewing to conduct telehealth sessions. Participants will also receive biweekly text messages aligned with module content. Post-intervention follow-up will occur at 6- and 12-month post-randomization.
  • No Intervention: Usual Care (UC) arm
    This group will receive biweekly text messages on general health behaviors as a retention strategy. This arm will receive no other outside interventions. The Dental Resource directory will be provided to all participants.

Primary Outcome Measure

mucositis [ Time Frame: baseline and repeated at 6 and 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Georgetown Lombardi Office of Minority HealthWashington D.C.District of Columbia20003
N. Lewis
[email protected]
202-687-5367

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By research site
Georgetown Lombardi Office of Minority Health· Washington D.C., DC

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