Survivorship and Late Effects in Head and Neck Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 265
- 试验地点
- 1
- 主要终点
- Prevalence of late effects after head and neck cancer treatment measured with patient-reported questionnaires
研究概览
简要总结
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.
详细描述
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;
- Chronic fatigue
- Hearing loss and tinnitus
- Oral late effects, including taste and smell disturbances and osteoradionecrosis
- Dysphagia and malnutrition
- 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
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
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
- •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 - 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
- •Diagnosed 2006- 2012
- •Ability to understand and respond to the questionnaires
- •Ability to attend the clinical examination
- •Informed consent received
排除标准
- •Unwillingness to answer HRQL questionnaires
- •Patients under ongoing treatment for secondary cancer or relapse at the time of the survey
结局指标
主要结局
Prevalence of late effects after head and neck cancer treatment measured with patient-reported questionnaires
时间窗: 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. Patients filled in a set of patient-reported questionnaires: 1) EORTC core quality of life questionnaire, the EORTC QLQ-C30 version 3, 2) EORTC disease specific module, the EORTC QLQ-H\&N35 3) The Fatigue Questionnaire, 4) The scale for chemotherapy induced neurotoxicity (SCIN), 5) EORTC-QLQ-OH15, 6) Body image scale.
次要结局
- Risk factors for late effects after head and neck cancer treatement(June 2022)
研究者
Cecilie Delphin Amdal
Senior Oncologist, PhD, Researchgroupleader skin and head and neck cancer, Department of Oncology
Oslo University Hospital