Return to Work and Living Healthy After Head and Neck Cancer

NCT03065634 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2020-11-05

No results posted yet for this study

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.

Conditions

Interventions

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

BEHAVIORAL

socio-legal counseling

Non-manualized socio-legal counseling two socio-legal counseling sessions delivered by a social worker

Sponsors & Collaborators

  • Universitätsklinikum Leipzig

    collaborator OTHER
  • Jena University Hospital

    collaborator OTHER
  • Klinikum St. Georg gGmbH

    collaborator OTHER
  • Stadtisches Klinikum Dresden

    collaborator OTHER
  • German Cancer Aid

    collaborator OTHER
  • University of Leipzig

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-01
Primary Completion
2018-09-30
Completion
2018-12-31

Countries

  • Germany

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03065634 on ClinicalTrials.gov