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Trial Title:
Leveraging Telehealth to Improve Oral Health Among Cancer Survivors
NCT ID:
NCT06315855
Condition:
Oral Mucositis
Periodontal Diseases
Cancer
Conditions: Official terms:
Mucositis
Periodontal Diseases
Stomatitis
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
Double (Participant, Investigator)
Intervention:
Intervention type:
Behavioral
Intervention name:
Telehealth Intervention (THI)
Description:
The 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.
Arm group label:
Telehealth Intervention (THI) arm
Summary:
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.
Detailed description:
The goal of this study is to assess the efficacy of a Telehealth Intervention (THI) in 1)
yielding more favorable oral health outcomes (e.g., reduced treatment-related mucositis,
reduced gingival inflammation, tooth preservation); better oral health-related quality of
life (OHRQoL). The investigators will also assess the efficacy of THI in yielding
decreased systemic inflammation compared to usual care (UC).
The Study population will comprise 100 unselected cancer survivors who will be recruited
through community-based approaches. The goal is to enroll 50 active treatment and 50
post-treatment into the study.
Intraoral Imaging All participants, prior to randomization will undergo an intraoral
imaging assessment.
Intraoral imaging will be conducted on all study participants at the time of their
baseline in- person visit. Photos of the mouth, teeth, and gums will be captured and
saved in individual patient files for research and data purposes only. The images
captured by the intraoral imaging exam will not be uploaded to any electronic healthcare
records for dentist or hygienist use; these images are strictly for the use of research
staff. These images will be the data for the study, as both baseline and succeeding
follow-up images will be taken. These images will be used to analyze the oral health and
overall quality of life of the subjects. The investigators will have a dental consultant
review images and provide summary data.
Biospecimens Saliva samples will be collected at baseline, 6-,and 12-month
post-randomization.
Participants will self-collect the saliva sample using the Omnigene Saliva DNA and RNA
device (OMR-610). Blood samples (10 mL) for biomarker assessments at baseline and
follow-up visits (i.e., 6- and 12- months) Inflammation markers including C-reactive
protein, IL-1, IL-6, and TNF-alpha will be measured. Samples will be processed within two
hours and stored at -70°C. Saliva samples will be stored for up to 21 days at room
temperature, and then will be stored at -20 °C. Human and microbial DNA and RNA will be
extracted to examine oral microbiome.
Survey Instruments Basic demographics and lifestyle characteristics will include smoking,
physical activity, and diet, clinical characteristics, cancer-treatment questionnaire,
EORTC oral and overall quality of life questionnaires (QLQ-C30 and OH-15), Oral Health
Impact Profile (OHIP-14), patient-reported oral mucositis symptom scale, and Area
Deprivation Index.
Anthropometric measures of height, weight, waist and hip circumference will also be
collected. All survey and anthropometric measurements will be collected at baseline, 6-
and 12- month post-randomization.
Clinical Trial Arms This is a six-month 2-arm randomized controlled trial comprising a
Telehealth Intervention (THI) arm and a Usual Care (UC) arm as described below
Telehealth Intervention (THI) This is based on e-Health and mobile Health and utilizes
the use of information and communication technologies for health. More specifically this
telehealth method is a medical and public health practice that is supported by mobile
devices, such as mobile phones, patient monitoring devices, personal digital assistants,
and other wireless devices. This method allows for the monitoring of oral health
conditions and alert the patient or oncologist about an emerging oral health issue.
Moreover, telehealth reduces the need to come into an office for a visit.
Outcomes
The following outcomes will be measured in all participants at baseline and repeated at 6
and 12 months:
ORAL HEALTH OUTCOMES
1. mucositis: clinical via intro-oral imaging using the WHO oral mucositis grading
scale) and the patient-reported oral mucositis symptom scale (PROMS) questionnaire
2. gingival inflammation and periodontal disease: Modified Gingival Index based on
intraoral imaging
3. tooth decay: Delayed, Missing, Filled Teeth (DMFT) index based on intraoral imaging
4. 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)
SYSTEMIC OUTCOMES
1. systemic inflammation: Inflammation markers measured in peripheral blood samples
2. overall health related quality of life: measured using EORTS QLQ-C30 questionnaire
3. comorbidities: cardiovascular and metabolic comorbidities including diabetes,
hypertension, heart disease, and stroke will be determined from the medical record
Statistical Analysis Demographic and other baseline data including cancer-related
clinical characteristics will be listed and summarized descriptively by intervention arm
(THI and UC). Categorical data will be presented as frequencies and percentages. For
continuous data, mean, standard deviation, median, minimum, and maximum will be
presented. For selected parameters, 25th and 75th percentiles will also be presented.
Intention to treat (ITT) analysis will be performed for all participants who enrolled and
randomly allocated to one of the clinical trials arms to which they were randomized.
Descriptive statistics will be used to summarize the original scores for the outcomes
(oral and systemic health outcomes), as well as change from baseline, at each scheduled
assessment timepoint for the THI and UC group. Additionally, change from baseline in the
scale and subscale values at the time of each assessment will be summarized. Participants
with an evaluable baseline score and at least one evaluable post baseline score during
the treatment period will be included in the change from baseline analyses.
The number of participants completing each questionnaire and the number of missing or
incomplete assessments will be summarized by treatment group for each scheduled
assessment timepoint. A repeated measurement analysis model for longitudinal data will be
used to estimate differences in the scores of mucositis, oral and systemic inflammation,
tooth decay, and oral and overall quality of life between the THI and UC arms. The
differences in least square means between the treatment arms and corresponding 95%
confidence interval at selected timepoints will be presented. Details, including handling
of missing data, will be specified in the detailed protocol for the study.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
25 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
June 25, 2024
Completion date:
August 25, 2027
Lead sponsor:
Agency:
Georgetown University
Agency class:
Other
Source:
Georgetown University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06315855