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

NCT06315855 | Recruiting

• 1 other identifier: STUDY00007140
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (4)

• mucositis

  The World Health Organization Oral Toxicity Scale rates the anatomical, and function aspects of oral mucositis. The severity of oral ulcers and ability to consume food and liquid is reported on a scale of 0 (no presentation of symptoms) to 4 (not able to tolerate food or liquid diet). Higher scores indicate worse oral mucositis symptomology. The PROMS questionnaire: Respondents will indicate their level of oral mucositis symptoms on a sliding scale ranging from no experience of a mucositis-related symptoms to complete experience of symptoms. Higher scores indicate worse self-reported mucositis.

  baseline and repeated at 6 and 12 months

• gingival inflammation and periodontal disease

  Using the modified gingival index, the investigators will rate inflammation of gums on a 5-point Likert Scale ranging from 0 (absence of inflammation) to 4(severe inflammation, marked redness, edema. Higher scores indicate more severe inflammation.

  baseline and repeated at 6 and 12 months

• tooth decay

  Delayed, Missing, Filled Teeth (DMFT) index based on intraoral imaging The DMFT index will be calculated by summing the number of delayed, missing, or filled teeth and dividing this value by the sum of the DMFT values in the study sample. Higher values equate to poorer tooth retention.

  baseline and repeated at 6 and 12 months

• oral health related quality of life

  Oral health Impact Profile (14-item OHIP-14 questionnaire) and the cancer specific oral health questionnaires (EORTC Quality of Life Questionnaires - oral health) This measure assesses the impact of oral health on overall wellbeing. Respondents will indicate their agreement with a statement (Yes/No). Higher scores indicate a greater impact of oral health on daily life. EORTC- Quality of Life Questionnaires Oral health: For items 1-11, Respondents indicate agreements on a 4-point Likert scale ranging from 1(not at all) to 4(Very much). On items 12-15, respondents indicate dichotomous agreement (Yes/No). Scores are summed and logged transformed to 0-100 scale. Higher scores indicate a better oral health related quality of life and better functioning.

  baseline and repeated at 6 and 12 months

Secondary Outcomes (3)

• systemic inflammation

  baseline and repeated at 6 and 12 months

• overall health related quality of life

  baseline and repeated at 6 and 12 months

• comorbidities

  baseline and repeated at 6 and 12 months

Study Arms (2)

Telehealth Intervention (THI) arm

EXPERIMENTAL

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.

Behavioral: Telehealth Intervention (THI)

Usual Care (UC) arm

NO INTERVENTION

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.

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.

Telehealth Intervention (THI) arm

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• male and female cancer survivors who are either ≥ 6 months after competing primary therapy for cancer treatment (N=100)
• between 25-75 years of age
• all race/ethnic groups
• own a smart phone.

You may not qualify if:

• all head and neck/oral cancer survivors
• less then 25 years and older than 75 years of age
• recurrence/second cancers or undergoing treatment
• unable to provide informed consent.

Sponsors & Collaborators

• Georgetown University: lead

Study Sites (1)

Georgetown Lombardi Office of Minority Health

Washington D.C., District of Columbia, 20003, United States

RECRUITING

Related Publications (1)

• Dash C, Smith DI, Williams N, Leby C, Nyirenda N, Makambi KH, Adams-Campbell L. 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. Trials. 2025 Nov 24;26(1):535. doi: 10.1186/s13063-025-09247-1.

  PMID: 41286997 DERIVED

MeSH Terms

Conditions

Stomatitis; Periodontal Diseases; Neoplasms

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Central Study Contacts

Smith

CONTACT

202-687-5367; ds1924@georgetown.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2024
• First Posted: March 18, 2024
• Study Start: August 20, 2024
• Primary Completion (Estimated): August 25, 2026
• Study Completion (Estimated): August 25, 2027
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)