Head and Neck Cancer, Head and Neck Cancer Squamous Cell Carcinoma
Conditions
Keywords
Head and neck cancer, Nutrition, Oral health, cancer survivors, Quality of Life, healthcare costs
Brief summary
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?
Detailed description
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.
Interventions
OTHEROral health support
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. During visits to the dental hygienist, they will be asked about oral hygiene habits, fluoride use, dry mouth problems, and dietary habits (including intake of easily degradable carbohydrates). Oral dryness will be assessed using the Clinical Oral Dryness Scale. The stimulated salivary secretion and buffering capacity will be assessed, and the ability to open the mouth, cariological and periodontal status and registered plaque. Based on the results of the clinical examination, the patient will get individually tailored advice and recommendations on oral hygiene, fluoride use, dry mouth relief, and support in reducing the intake of food items and drinks with high sugar content. Professional oral care will be given, and fluoride applications when indicated.
Sponsors
Uppsala University
Region Västerbotten
Region Östergötland
The Sjöberg Foundation
The Stig & Ragna Gorthon Foundation, Helsingborg
Swedish Cancer Society
Region Uppsala Public Health and Care
Region Skane
Laryngfonden
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients (≥ 18 years) * diagnosed with HNC * scheduled for treatment with curative intent, including RT or CRT with or without surgery
Exclusion criteria
* severe alcoholism * cognitive impairment * inability to understand the Swedish language
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Number of remaining teeth, mouth opening ability, presence of caries, periodontitis, salivary composition and osteoradionecrosis |
| 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. | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). Scores are linearly transformed to a 0-100 scale. Higher scores indicate better functioning and quality of life for the functional and global health status scales, whereas higher scores indicate more severe symptoms for the symptom scales and single-item measures. |
| 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. | Return to work and sick leave patterns. |
| 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 | Malnutrition according to the Global Leadership Initiative on Malnutrition (GLIM) criteria |
| 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 | Self-reported oral health, psychological well-being (depression, anxiety and stress), and self-efficacy |
Countries
Sweden
Contacts
CONTACTYlva Tiblom Ehrsson, Assoc professor, RN
Outcome results
None listed