F.L.O.S.S. Project: Telehealth for Oral Health in Cancer Survivors
This study, called the F.L.O.S.S. Project, is testing a 6-month Telehealth Intervention (THI) to help cancer survivors with their oral health. The THI involves monthly telehealth calls with a nurse practitioner or navigator to check on oral and health symptoms. Researchers want to see if THI can prevent problems like oral mucositis (mouth sores), gingivitis (gum inflammation), and tooth decay, improve your quality of life related to oral health, and reduce inflammation in your body. You may be able to join if you are a cancer survivor between 25 and 75 years old, at least 6 months after your main cancer treatment, and own a smartphone. The study aims to enroll 100 participants.
- Study design
- This is a randomized controlled trial comparing the Telehealth Intervention (THI) to usual care, involving 100 participants.
- What's involved
- You would participate in a 6-month intervention with monthly telehealth calls and have oral assessments at the beginning, 6 months, and 12 months.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your oral health will be assessed at 6 and 12 months after the start of the study.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
F.L.O.S.S. Project (Facilitated Lessons on Oral and Systemic Health in Survivors)
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Inclusion
Exclusion
What this trial measures
- mucositisbaseline and repeated at 6 and 12 months
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.
- gingival inflammation and periodontal diseasebaseline and repeated at 6 and 12 months
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.
- tooth decaybaseline and repeated at 6 and 12 months
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.
- oral health related quality of lifebaseline and repeated at 6 and 12 months
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.