Improved Oral Health in Head and Neck Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 3
- 主要终点
- Health-related quality of life
研究概览
简要总结
The goal of this clinical trial is to learn if an oral care programme, designed as a multicentre two-armed randomised controlled trial (RCT), can prevent or mitigate late oral sequalae following completion of head and neck cancer (HNC) treatment, and assessing its impact on health-related quality of life (HRQoL), oral health, work ability, nutritional status, psychological well-being, and healthcare-related economic costs. The intervention consists of an oral care programme given to the intervention group (HNC survivors) from six months after the end of treatment and every three months for three years.
The main questions it aims to answer are:
- Does the intervention improve oral health, nutritional status, HRQoL, and reduce stress and anxiety compared with standard care?
- Does the intervention reduce the duration of sick leave and improve return-to-work outcomes compared with standard care?
- Is the intervention cost-effective from a health economic perspective?
- Does the intervention improve patients' self-efficacy in managing their oral health and related challenges compared with standard care?
- Does the intervention influence self-reported oral health, oral health-related behaviours, and oral health knowledge over time compared with standard care?
- Do the effects of the intervention differ according to age, sex and sociodemographic factors?
- Does the intervention affect salivary composition and salivary biomarkers over time compared with standard care?
详细描述
In Sweden, approximately 1,800 individuals are diagnosed with head and neck cancer (HNC) each year. Treatment includes radiotherapy or surgery, sometimes combined with systemic anti-cancer therapy (SACT). The five-year survival rate for the entire group is now approximately 70%. Despite improved five-year survival during the last two decades, side effects such as decreased salivation, difficulty swallowing, pain and radiation-induced caries are common, which negatively affect quality of life. Thus, therapeutic improvements that support oral health are highly demanded among the large group surviving HNC. The research project is a multicentre randomised controlled trial evaluating the effectiveness of an oral care programme in preventing or reducing late oral side effects in patients with HNC following treatment. Through a collaborative effort across five healthcare regions, this study aims to provide robust evidence of the efficacy of interventions designed to improve oral health outcomes and enhance the overall quality of life among HNC survivors. The intervention group will visit a dental hygienist every 3 months for oral health examination and treatment, whereas the control group will receive standard care (i.e., they will contact dental care on their own, if needed). Data collection will include patient-reported outcome measures, nutritional status, oral and dental assessments, as well as saliva and blood samples. The goal is to enhance the understanding of how oral health and quality of life can be improved in this vulnerable group, as well as how health economic costs can be reduced.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients (≥ 18 years)
- •diagnosed with HNC
- •scheduled for treatment with curative intent, including RT or CRT with or without surgery
排除标准
- •severe alcoholism
- •cognitive impairment
- •inability to understand the Swedish language
研究组 & 干预措施
Oral health intervention
The intervention group will receive examination and treatment by a dental hygienist every 3 months starting 6 months after completion of RT/CRT up to 3 years.
干预措施: Oral health support (Other)
结局指标
主要结局
Health-related quality of life
时间窗: Data will be collected before RT/CRT begins (baseline), at 6 months after the completion of RT/CRT (randomisation, start of intervention), and at one, two and three years.
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Cancer Module (EORTC QLQ-HN43) EORTC QLQ-HN43 scores are linearly transformed to a 0-100 scale. Higher scores indicate greater symptom burden and more severe disease- or treatment-related problems, corresponding to poorer health-related quality of life.
Number of remaining teeth
时间窗: Data will be collected before RT/CRT begins (baseline), at 6 months after the completion of RT/CRT (randomisation, start of intervention), and at one, two and three years
Maximum interincisal opening (MIO)
时间窗: Data will be collected before RT/CRT begins (baseline), at 6 months after the completion of RT/CRT (randomisation, start of intervention), and at one, two and three years
Presence of caries
时间窗: Data will be collected before RT/CRT begins (baseline), at 6 months after the completion of RT/CRT (randomisation, start of intervention), and at one, two and three years
Loss of supporting tissue (periodontitis)
时间窗: Data will be collected before RT/CRT begins (baseline), at 6 months after the completion of RT/CRT (randomisation, start of intervention), and at one, two and three years
Osteoradionecrosis.
时间窗: Data will be collected before RT/CRT begins (baseline), at 6 months after the completion of RT/CRT (randomisation, start of intervention), and at one, two and three years
次要结局
- Quantitative oral health indicators(Data will be collected before RT/CRT begins (baseline), at 6 months after the completion of RT/CRT (randomisation, start of intervention), and at one, two and three years)
- Generic cancer-related HRQoL(Data will be collected before RT/CRT begins (baseline), at 6 months after the completion of RT/CRT (randomisation, start of intervention), and at one, two and three years.)
- Return to work(Data will be collected before RT/CRT begins (baseline), at 6 months after the completion of RT/CRT (randomisation, start of intervention), and at one, two and three years History taking from research and clinical nurses.)
- Nutritional status(Data will be collected before RT/CRT begins (baseline), at 6 months after the completion of RT/CRT (randomisation, start of intervention), and at one, two and three years)
- Healthcare-related economic costs(Register data will cover the period from one year prior to diagnosis to five years after the completion of treatment)
- Patient-reported outcome measures (PROMs)(Data will be collected before RT/CRT begins (baseline), at 6 months after the completion of RT/CRT (randomisation, start of intervention), and at one, two and three years)
- Health-related quality of life(Data will be collected before RT/CRT begins (baseline), at 6 months after the completion of RT/CRT (randomisation, start of intervention), and at one, two and three years.)