Clinical trial · Interventional
F.L.O.S.S. Project (Facilitated Lessons on Oral and Systemic Health in Survivors)
NCT06315855CI-TRIAL-00101458recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Oral Mucositis | — | UNRESOLVED | — |
| Periodontal Diseases | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Telehealth Intervention (THI) | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Telehealth Intervention (THI) arm
- description
- 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.
- interventionNames
- Behavioral: Telehealth Intervention (THI)
- type
- NO_INTERVENTION
- label
- Usual Care (UC) arm
- description
- 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 outcomes (4)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 25 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (1)
- DERIVEDDash 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