Return to Work and Living Healthy After Head and Neck Cancer
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Work ability
研究概览
简要总结
Based on a randomized controlled trial, the manualized group intervention Return to work and living healthy after head and neck cancer (RELIANCE) for head and neck cancer survivors will be tested against a non-manualized control intervention (social counseling) in order to evaluate the efficacy of the RELIANCE intervention compared to the control condition. The study design includes two phases, the initial study phase (pilot study) and the intervention study (RCT). The aim of the pilot study is to implement and ensure the necessary standardized procedures for the implementation of patient recruitment and interventions. In the randomized controlled trial, potential participants are assigned to the intervention group or to the control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Open Label
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of laryngea, hypopharyngeal, oropharyngeal, tonsil or base of the tongue cancer within the last six months
- •Curative treatment
- •Completion of primary and follow-up Treatment
- •Fluency in German
- •Written informed and voluntary consent
- •Psychological distress (Distress Thermometer score > 4)
- •Self-perceived prognosis of employment (SPE score ≥ 1)
排除标准
- •Alcohol dependency with physical withdrawal symptoms (CAGE score ≥ 3 and current use of alcohol)
- •Acute suicidal tendencies
- •Receiving old-age pension or will receive old-age pension within the next 12 months
- •Cognitive impairment indicated in the medical records or by the attending doctor
- •Being in psychotherapy
研究组 & 干预措施
Non-manualized socio-legal counseling
two socio-legal counseling sessions delivered by a social worker
干预措施: socio-legal counseling (Behavioral)
Manualized RELIANCE intervention
Return to work and living healthy after head and neck cancer (RELIANCE) is a 2-months group intervention for head and neck cancer patients delivered by a trained psychotherapist and a peer in eight sessions.
干预措施: Return to work and living healthy after head and neck cancer (Behavioral)
结局指标
主要结局
Work ability
时间窗: directly after intervention and at six months follow-up
Work-Ability-Index, short version (WAI)
Pattern of work-related coping behaviour
时间窗: directly after intervention and at six months follow-up
Pattern of work-related coping behaviour, short Version (AVEM-44)
次要结局
- Cancer-specific health-related quality of Life (global, functioning, symptom burden)(directly after intervention and at six months follow-up)
- Quality of life and symptoms specific to head and neck cancer(directly after intervention and at six months follow-up)
- anxiety, depression and psychological distress in patients with somatic diseases(directly after intervention and at six months follow-up)
- health behavior and health related attitudes and knowledge about specific diseases(directly after intervention and at six months follow-up)
- general self-efficacy expectation(directly after intervention and at six months follow-up)
研究者
Anja Mehnert
Prof. Dr.
University of Leipzig