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
Abstract
Background: 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?".
Methods: 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.
Discussion: 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…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 100 participants or records.
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