Clinical trial NCT03065634: Return to Work and Living Healthy After Head and Neck Cancer
Official title: Return to Work and Living Healthy After Head and Neck Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Head and Neck Cancer
Lead sponsor: University of Leipzig
Sponsor class: OTHER
Collaborators: name: Universitätsklinikum Leipzig
name: Jena University Hospital
name: Klinikum St. Georg gGmbH
name: Stadtisches Klinikum Dresden
name: German Cancer Aid
First posted: 2017-02-28
Enrollment: 39
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Work ability
timeFrame: directly after intervention and at six months follow-up
measure: Pattern of work-related coping behaviour
timeFrame: directly after intervention and at six months follow-up
Secondary outcomes:
measure: Cancer-specific health-related quality of Life (global, functioning, symptom burden)
timeFrame: directly after intervention and at six months follow-up
measure: Quality of life and symptoms specific to head and neck cancer
timeFrame: directly after intervention and at six months follow-up
measure: anxiety, depression and psychological distress in patients with somatic diseases
timeFrame: directly after intervention and at six months follow-up
measure: health behavior and health related attitudes and knowledge about specific diseases
timeFrame: directly after intervention and at six months follow-up
measure: general self-efficacy expectation
timeFrame: directly after intervention and at six months follow-up
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: University Medical Center Leipzig
state: Saxony
Study officials:
References: