Clinical trial · Interventional
Return to Work and Living Healthy After Head and Neck Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): insufficient recruitment rate
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Return to work and living healthy after head and neck cancer | Behavioral | — | UNRESOLVED |
| socio-legal counseling | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Manualized RELIANCE intervention
- description
- 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.
- interventionNames
- Behavioral: Return to work and living healthy after head and neck cancer
- type
- ACTIVE_COMPARATOR
- label
- Non-manualized socio-legal counseling
- description
- two socio-legal counseling sessions delivered by a social worker
- interventionNames
- Behavioral: socio-legal counseling
Primary outcomes (2)
- measure
- Work ability
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available