F.L.O.S.S. Project (Facilitated Lessons on Oral and Systemic Health in Survivors)
Georgetown University
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.
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-treatmen…
Eligibility
- Age range
- 25–75 years
- Sex
- All
- Healthy volunteers
- No
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.
Interventions
- BehavioralTelehealth Intervention (THI)
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.
Location
- Georgetown Lombardi Office of Minority HealthWashington D.C., District of Columbia