Head and Neck Cancer, Head and Neck Carcinoma, Head and Neck Neoplasms
Conditions
Keywords
Oral health, Fluoride varnish, Dental care, Radiation therapy
Brief summary
This is a pilot study evaluates the feasibility and outcomes of providing fluoride varnish treatment during routine cancer surveillance visits for post-radiation head and neck cancer patients with limited access to dental care.
Detailed description
PRIMARY OBJECTIVES: I.To describe the baseline knowledge and access to dental care of underinsured/uninsured head and neck cancer patients treated with radiation at University California of San Francisco (UCSF) and Zuckerberg San Francisco General Hospital and Trauma Center (ZSFG). II.To pilot and characterize the feasibility and outcomes of an in-clinic fluoride varnish dental treatment paired with routine cancer surveillance for post-radiation head and neck cancer patients who do not have reliable access to dental care III.To develop readily accessible patient educational material for dental care after radiation treatment for HNC. SECONDARY OBJECTIVES: I. Explore barriers and facilitators to adapting an integrated preventative fluoride intervention into clinical care for HNC patients through qualitative interviews. II. Co-design patient advocacy materials and a clinician implementation toolkit to provide a framework for adopting this intervention diverse community-based settings
Interventions
OTHERSurveys
Participants will complete surveys to collect information about their dental health before and after fluoride varnish treatment. Healthcare and dental providers will complete a survey to assess the feasibility of the fluoride varnish treatment.
PROCEDURESaliva Collection
Participants will provide a saliva sample for pH measurement.
PROCEDUREIntra-oral photographs
Images of participants' teeth will be taken to assess the Decayed, Missing, and Filled Teeth (DMFT) index.
DEVICEFluoride Varnish Treatment
Participants will receive 4-5 fluoride varnish treatment every 3 month over the course of a year. Treatment is delivered during cancer surveillance visits. Participant will also receive dental care educational materials.
OTHERInterview (Participant)
Participants and caregivers will share their experiences accessing dental care, identify barriers to care, and provide their views on integrating preventive dental care into routine medical care. Healthcare and dental providers will share their observations about patient access to dental care and their views on integrating preventive dental care into routine medical care.
Sponsors
University of California, San Francisco
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. \>18 years old who are uninsured or underinsured (MediCal, Healthy SF) or have full coverage. 2. Patients who have received immunotherapy or enhanced chemotherapy regimens. 3. Patients or health and dental care providers who are able to provide their own informed written consent.
Exclusion criteria
1. \>18 years old. 2. Patients, caregivers, health and dental care providers who are able to provide their own informed written consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean score of Feasibility of Intervention Measure (FIM) | Up to 1 year | The Feasibility of Intervention Measure (FIM) is a 4-item implementation measure that assesses participants or providers' perceived feasibility of the intervention. Responses are rated on a 5-point Likert scale ranging from 1 (Completely Disagree) to 5 (Completely Agree). The survey is administered at baseline and at each surveillance visit. |
| Interview | Up to one day | Interview will be conducted with participants and providers using guided questions. Responses will be analyzed to assess the feasibility and potential for expanding the fluoride varnish program. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change of Score of Dental Care Practice | Up to 1 year | The Dental Care Practices Survey assesses oral health behaviors and dental care utilization, including frequency of dental visits, toothbrushing tools, and flossing practices. Mean changes in survey scores will be evaluated to assess changes in dental care practices following fluoride varnish treatment and dental health education. Participants will complete the survey at baseline and at each surveillance visit. |
| Mean Change of Score of Familiarity with the Risks of Radiation | Up to 1 year | The Familiarity with the Risks of Radiation Survey assesses knowledge of the effects of head and neck radiation on oral health and attitudes toward seeking dental care. Mean changes in survey scores will be evaluated to assess changes in knowledge and attitudes following fluoride varnish treatment and dental health education. Participants will complete the survey at baseline and at each surveillance visit. |
| Change in Saliva potential hydrogen (pH) measure | Up to 1 year | Changes in salivary potential hydrogen (pH) will be evaluated to assess changes in oral health status following fluoride varnish treatment and dental health education. Saliva samples will be collected from participants at baseline and at each surveillance visit, and pH will be measured using a digital pH meter. |
| Mean Change of Score of Oral Health-Related Quality of Life (OHRQoL) | Up to 1 year | Participants will complete the Oral Health Impact Profile-14 (OHIP-14) to assess oral health-related quality of life (OHRQoL). The OHIP-14 is a 14-item questionnaire that measures OHRQoL across seven domains: functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability, and handicap. Responses are rated on a 5-point Likert scale ranging from 0 (Never) to 5 (Always). Mean changes in OHRQoL scores will be used to evaluate changes following fluoride varnish treatment and dental health education. The questionnaire will be completed at baseline and at each surveillance visit. |
| Mean score Change in Decayed-Missing-Filled Teeth (DMFT) Index | Up to 1 year | The Decayed, Missing, and Filled Teeth (DMFT) index is measured as the number of decayed, missing, and filled teeth. Mean changes in DMFT scores will be used to evaluate changes in oral health following fluoride varnish treatment and dental health education. The DMFT assessment will be performed at baseline and at each surveillance visit. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMary J Xu, MD
University of California, San Francisco
Outcome results
None listed