# 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

## TL;DR

This study tests if telehealth can improve oral and overall health in cancer survivors through a 6-month intervention.

## Contribution

The FLOSS Project is one of the first randomized trials to examine telehealth's role in improving oral and systemic health in cancer survivors.

## Key findings

- Participants will be randomized into telehealth or usual care groups and followed for 12 months.
- The study will assess oral and systemic health outcomes using intraoral images, blood/saliva samples, and questionnaires.
- The intervention includes six monthly sessions focused on oral health knowledge and behavior change techniques.

## Abstract

The oral health of cancer survivors can be compromised by cancer treatment, resulting in reduced treatment efficacy and poorer quality of life. Data suggests that targeting oral health may improve systemic health outcomes in cancer survivors. The Facilitated Lessons on Oral and Systemic Health in Survivors (FLOSS) Project is a 2-arm, 6-month randomized controlled trial (RCT), purposed to answer the research question, “What is the role of oral telehealth in yielding more favorable oral and systemic health outcomes in cancer survivors?”.

Participants (N = 100) will be recruited and randomized to the telehealth intervention (THI; n = 50) or usual care (UC, n = 50) arm. THI participants will engage in six monthly sessions designed to increase oral health-related knowledge and self-efficacy. Sessions utilize motivational interviewing and rely on behavior change techniques including: self-monitoring, goal-setting and implementation planning. Assessments of oral and systemic health outcomes will be conducted at baseline, 6- and 12-months and consist of: intraoral images, blood and saliva collection, and questionnaires to assess quality of life, lifestyle behaviors, and demographics.

FLOSS Project is one of the first theory-driven, randomized controlled trials examining the role of oral telehealth in promoting oral and systemic health in cancer survivors and is responsive to national health and research priorities. Successful completion of this project will provide evidence for an accessible intervention to promote oral and systemic health from an integrative lens in cancer survivors, post primary treatment.

ClinicalTrials.gov; NCT06315855. Registered on 03/11/2024.