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

Primary Purpose

Head and Neck Cancer

Status
Terminated
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Return to work and living healthy after head and neck cancer
socio-legal counseling
Sponsored by
University of Leipzig
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • University Medical Center Leipzig

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Manualized RELIANCE intervention

Non-manualized socio-legal counseling

Arm 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.

two socio-legal counseling sessions delivered by a social worker

Outcomes

Primary Outcome Measures

Work ability
Work-Ability-Index, short version (WAI)
Pattern of work-related coping behaviour
Pattern of work-related coping behaviour, short Version (AVEM-44)

Secondary Outcome Measures

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)
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)
anxiety, depression and psychological distress in patients with somatic diseases
Hospital Anxiety and Depression Scale (HADS)
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)
general self-efficacy expectation
general self-efficacy expectation (ASKU)

Full Information

First Posted
February 17, 2017
Last Updated
November 3, 2020
Sponsor
University of Leipzig
Collaborators
Universitätsklinikum Leipzig, Jena University Hospital, Klinikum St. Georg gGmbH, Stadtisches Klinikum Dresden, German Cancer Aid
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1. Study Identification

Unique Protocol Identification Number
NCT03065634
Brief Title
Return to Work and Living Healthy After Head and Neck Cancer
Acronym
RELIANCE
Official Title
Return to Work and Living Healthy After Head and Neck Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Terminated
Why Stopped
insufficient recruitment rate
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
September 30, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Leipzig
Collaborators
Universitätsklinikum Leipzig, Jena University Hospital, Klinikum St. Georg gGmbH, Stadtisches Klinikum Dresden, German Cancer Aid

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
Open Label
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Manualized RELIANCE intervention
Arm Type
Experimental
Arm 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.
Arm Title
Non-manualized socio-legal counseling
Arm Type
Active Comparator
Arm Description
two socio-legal counseling sessions delivered by a social worker
Intervention Type
Behavioral
Intervention Name(s)
Return to work and living healthy after head and neck cancer
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. The individual sessions aim to improve work ability, quality of life and psychological well-being
Intervention Type
Behavioral
Intervention Name(s)
socio-legal counseling
Intervention Description
Non-manualized socio-legal counseling two socio-legal counseling sessions delivered by a social worker
Primary Outcome Measure Information:
Title
Work ability
Description
Work-Ability-Index, short version (WAI)
Time Frame
directly after intervention and at six months follow-up
Title
Pattern of work-related coping behaviour
Description
Pattern of work-related coping behaviour, short Version (AVEM-44)
Time Frame
directly after intervention and at six months follow-up
Secondary Outcome Measure Information:
Title
Cancer-specific health-related quality of Life (global, functioning, symptom burden)
Description
Quality of Life Core Questionnaire of the European Organisation for Research and Treatment of Cancer (EORTC-QLQ-C30)
Time Frame
directly after intervention and at six months follow-up
Title
Quality of life and symptoms specific to head and neck cancer
Description
Head and Neck Module of the European Organisation for Research and Treatment of Cancer (EORTC-H&N35)
Time Frame
directly after intervention and at six months follow-up
Title
anxiety, depression and psychological distress in patients with somatic diseases
Description
Hospital Anxiety and Depression Scale (HADS)
Time Frame
directly after intervention and at six months follow-up
Title
health behavior and health related attitudes and knowledge about specific diseases
Description
questionnaire measuring health behavior and health related attitudes and knowledge about specific diseases (FEG)
Time Frame
directly after intervention and at six months follow-up
Title
general self-efficacy expectation
Description
general self-efficacy expectation (ASKU)
Time Frame
directly after intervention and at six months follow-up

10. Eligibility

Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
University Medical Center Leipzig
City
Leipzig
State/Province
Saxony
ZIP/Postal Code
04103
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Links:
URL
http://medpsy.uniklinikum-leipzig.de/medpsych.site,postext,projekte-psychoonkologie-aktuell,a_id,8222.html
Description
Related Info

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Return to Work and Living Healthy After Head and Neck Cancer

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