Head and Neck Cancer
Conditions
Brief summary
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.
Interventions
BEHAVIORALReturn to work and living healthy after head and neck cancer
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
BEHAVIORALsocio-legal counseling
Non-manualized socio-legal counseling two socio-legal counseling sessions delivered by a social worker
Sponsors
Universitätsklinikum Leipzig
Jena University Hospital
Klinikum St. Georg gGmbH
Stadtisches Klinikum Dresden
German Cancer Aid
University of Leipzig
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Open Label
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Work ability | directly after intervention and at six months follow-up | Work-Ability-Index, short version (WAI) |
| Pattern of work-related coping behaviour | directly after intervention and at six months follow-up | Pattern of work-related coping behaviour, short Version (AVEM-44) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| anxiety, depression and psychological distress in patients with somatic diseases | directly after intervention and at six months follow-up | Hospital Anxiety and Depression Scale (HADS) |
| Cancer-specific health-related quality of Life (global, functioning, symptom burden) | directly after intervention and at six months follow-up | Quality of Life Core Questionnaire of the European Organisation for Research and Treatment of Cancer (EORTC-QLQ-C30) |
| general self-efficacy expectation | directly after intervention and at six months follow-up | general self-efficacy expectation (ASKU) |
| health behavior and health related attitudes and knowledge about specific diseases | directly after intervention and at six months follow-up | questionnaire measuring health behavior and health related attitudes and knowledge about specific diseases (FEG) |
| Quality of life and symptoms specific to head and neck cancer | directly after intervention and at six months follow-up | Head and Neck Module of the European Organisation for Research and Treatment of Cancer (EORTC-H&N35) |
Countries
Germany
Outcome results
None listed