F.L.O.S.S. Project (Facilitated Lessons on Oral and Systemic Health in Survivors)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25-75
SponsorGeorgetown University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Telehealth Intervention (THI)
BehavioralThe 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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Telehealth Intervention (THI) armExperimental treatment 1 intervention
Group B: Usual Care (UC) armNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
baseline and repeated at 6 and 12 months2
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.
Time frame
baseline and repeated at 6 and 12 months3
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.
Time frame
baseline and repeated at 6 and 12 months4
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.
Time frame
baseline and repeated at 6 and 12 monthsSecondary outcomes
1
systemic inflammation
Blood samples will be processed to separate plasma and buffy coat aliquots within two hours and stores at -80 degrees Celsius. The following biomarkers will be identified: C-reactive protein (mg/dL), IL-1 (pg/mL), IL-6 (pg/mL), and TNF-alpha (pg/mL).
Time frame
baseline and repeated at 6 and 12 months2
overall health related quality of life
EORTC Quality of Life-C30 will assess health-related quality of life. For items 1-28, respondents will indicate agreement on a 4-point Likert scale ranging from 1(Not at all) to 4(very Much). For items 29 and 30, respondents rate agreement on a 7-point Likert scale ranging from 1(very poor) to 7(excellent). Scores are summed and logged transformed to 0-100 scale. Higher scores indicate a better health-related quality of life and better functioning.
Time frame
baseline and repeated at 6 and 12 months3
comorbidities
Captured via self-report survey, participants will indicate prior or current diagnoses of cardiovascular and metabolic comorbidities including diabetes, hypertension, cardiovascular disease, stroke, etc. \- Anthropometrics * Height in centimeters rounded to the nearest tenth. * Weight in kilograms, captured on a calibrated scale. * Waist circumference in centimeters * Hip circumference in centimeters.
Time frame
baseline and repeated at 6 and 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov