Return to Work and Living Healthy After Head and Neck Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Return to Work and Living Healthy After Head and Neck Cancer

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Behavioral: Return to work and living healthy after head and neck cancer
* Behavioral: socio-legal counseling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Manualized RELIANCE intervention<br>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. | Behavioral: Return to work and living healthy after head and neck cancer<br>* 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. The individual sessions aim to improve work ability, quality of life and psychological well-being<br>|
| Active Comparator: Non-manualized socio-legal counseling<br>two socio-legal counseling sessions delivered by a social worker | Behavioral: socio-legal counseling<br>* Non-manualized socio-legal counseling two socio-legal counseling sessions delivered by a social worker<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Work ability | Work-Ability-Index, short version (WAI) | directly after intervention and at six months follow-up | 
| Pattern of work-related coping behaviour | Pattern of work-related coping behaviour, short Version (AVEM-44) | directly after intervention and at six months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cancer-specific health-related quality of Life (global, functioning, symptom burden) | Quality of Life Core Questionnaire of the European Organisation for Research and Treatment of Cancer (EORTC-QLQ-C30) | directly after intervention and at six months follow-up | 
| Quality of life and symptoms specific to head and neck cancer | Head and Neck Module of the European Organisation for Research and Treatment of Cancer (EORTC-H&N35) | directly after intervention and at six months follow-up | 
| anxiety, depression and psychological distress in patients with somatic diseases | Hospital Anxiety and Depression Scale (HADS) | directly after intervention and at six months follow-up | 
| health behavior and health related attitudes and knowledge about specific diseases | questionnaire measuring health behavior and health related attitudes and knowledge about specific diseases (FEG) | directly after intervention and at six months follow-up | 
| general self-efficacy expectation | general self-efficacy expectation (ASKU) | directly after intervention and at six months follow-up |