H&N Cancer; Survivorship and Late Effects
Study Details
Study Description
Brief Summary
A cross-sectional study on late effects after modern treatment in long-term survivors of head and neck cancer (HNC). Participants fill in questionnaires and participate at a one day visit at the hospital including blood sample with biomarkers, clinical examination, audiometry, oral radiological examination and oral examination. Data on patients' medical history collected from medical records including radiology images and digital radiotherapy plans.This will allow adjustments of treatment planning and improved treatment decisions for patients at risk, and improve information and follow up for future patients.
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Detailed Description
The purpose of this study is to provide knowledge on late effects and mortality risk after modern treatment in long-term survivors of head and neck cancer (HNC). This will allow adjustments of treatment planning and improved treatment decisions for patients at risk, and improve information and follow up for future patients. For head and neck cancer (HNC) survivors of today, with the rising proportion of HPV induced cancer and with improved modern treatment, the late effects and mortality risk has changed compared to survivors previous decades.
The investigators will assess the prevalence and severity of a broad range of late effects and identify associated risk factors for the following late effects;
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Chronic fatigue
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Hearing loss and tinnitus
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Oral late effects, including taste and smell disturbances and osteoradionecrosis
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Dysphagia and malnutrition
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Body image, intimacy and endocrine dysfunction
In addition,possible biological explanatory mechanisms for fatigue and possibly other selected late effects will be explored. Data will be compared to age and gender matched reference data for those where this is available.
Design: a cross-sectional study
Assessments: Patient-reported questionnaires, blood sample with biomarkers, clinical examination, audiometry, oral radiological examination and oral examination. Data on patients' medical history collected from medical records including radiology images and digital radiotherapy plans.
Study Design
Outcome Measures
Primary Outcome Measures
- Prevalence of late effects after head and neck cancer treatment [June 2022]
Assess prevalence of fatigue, dysphagia, xerostomia, hearing problems, oral health, body image and intimacy in surivors of head and neck cancer more than 5 years after treatment
Secondary Outcome Measures
- Risk factors for late effects after head and neck cancer treatement [June 2022]
to explore associated risk factors for fatigue, dysphagia, xerostomia, hearing problems, oral health in surivors of head and neck cancer more than 5 years after treatment
Eligibility Criteria
Criteria
Inclusion Criteria:
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Histologically or cytologically verified invasive carcinoma of the head and neck region; ICD10: C01, C02.0 - C02.9; C03.0 - C03.9; C04.0 - C04.9; C05.0 - C05.9; C06.0
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C06.9; C07; C08.0 - C08.9; C09.0 - C09.9; C10.0 - C10.9; C11.0 - C11.9; C12; C13.0 - C13.9; C14.0 - C14.9; C30; C31.0 - C31.9; C32.0 - C32.9, C77.0
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Diagnosed 2006- 2012
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Ability to understand and respond to the questionnaires
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Ability to attend the clinical examination
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Informed consent received
Exclusion Criteria:
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Unwillingness to answer HRQL questionnaires
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Patients under ongoing treatment for secondary cancer or relapse at the time of the survey
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Oslo University Hospital | Oslo | Norway | N-0424 |
Sponsors and Collaborators
- Oslo University Hospital
- University of Oslo
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2018-21