Return to Work and Living Healthy After Head and Neck Cancer (RELIANCE)

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.

Study Overview

• Status: Terminated
• Conditions: Head and Neck Cancer
• Intervention / Treatment: Behavioral: Return to work and living healthy after head and neck cancer; Behavioral: socio-legal counseling

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Saxony
    • Leipzig, Saxony, Germany, 04103
      • University Medical Center Leipzig

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Manualized RELIANCE intervention; 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.	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
ACTIVE_COMPARATOR: Non-manualized socio-legal counseling; two socio-legal counseling sessions delivered by a social worker	Behavioral: socio-legal counseling; Non-manualized socio-legal counseling two socio-legal counseling sessions delivered by a social worker

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Work ability	Work-Ability-Index, short version (WAI)	directly after intervention and at six months follow-up
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
general self-efficacy expectation	general self-efficacy expectation (ASKU)	directly after intervention and at six months follow-up

Collaborators and Investigators

• Sponsor: University of Leipzig
• Collaborators: Jena University Hospital; Klinikum St. Georg gGmbH; Universitätsklinikum Leipzig; German Cancer Aid; Stadtisches Klinikum Dresden

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2017
• Primary Completion (ACTUAL): September 30, 2018
• Study Completion (ACTUAL): December 31, 2018

Study Registration Dates

• First Submitted: February 17, 2017
• First Submitted That Met QC Criteria: February 22, 2017
• First Posted (ACTUAL): February 28, 2017

Study Record Updates

• Last Update Posted (ACTUAL): November 5, 2020
• Last Update Submitted That Met QC Criteria: November 3, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: 93000-133

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No