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NCT03065634 Clinical Trial

Return to Work and Living Healthy After Head and Neck Cancer

Head and Neck Cancer Clinical Trial

— RELIANCE  

Official title:
Return to Work and Living Healthy After Head and Neck Cancer

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT03065634
Other study ID # 93000-133
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date January 1, 2017
Est. completion date December 31, 2018

Study information
Verified date November 2020
Source University of Leipzig
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 39
Est. completion date December 31, 2018
Est. primary completion date September 30, 2018
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Return 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
• socio-legal counseling
Non-manualized socio-legal counseling two socio-legal counseling sessions delivered by a social worker

Locations
Country Name City State
Germany University Medical Center Leipzig Leipzig Saxony

Sponsors (6)
Lead Sponsor Collaborator
University of Leipzig German Cancer Aid, Jena University Hospital, Klinikum St. Georg gGmbH, Städtisches Klinikum Dresden, Universitätsklinikum Leipzig

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Work ability Work-Ability-Index, short version (WAI) directly after intervention and at six months follow-up
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary general self-efficacy expectation general self-efficacy expectation (ASKU) directly after intervention and at six months follow-up
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