A Randomized Controlled Trial Leveraging Telehealth to Improve Oral Health and Systemic Outcomes Among Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- mucositis
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
mucositis
时间窗: baseline 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 disease
时间窗: baseline 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 decay
时间窗: baseline 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 life
时间窗: baseline 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.
次要结局
- comorbidities(baseline and repeated at 6 and 12 months)
- systemic inflammation(baseline and repeated at 6 and 12 months)
- overall health related quality of life(baseline and repeated at 6 and 12 months)