NCT03065634

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable head-and-neck-cancer

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 17, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 28, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

November 5, 2020

Status Verified

November 1, 2020

Enrollment Period

1.7 years

First QC Date

February 17, 2017

Last Update Submit

November 3, 2020

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (5)

  • Cancer-specific health-related quality of Life (global, functioning, symptom burden)

    directly after intervention and at six months follow-up

  • Quality of life and symptoms specific to head and neck cancer

    directly after intervention and at six months follow-up

  • anxiety, depression and psychological distress in patients with somatic diseases

    directly after intervention and at six months follow-up

  • health behavior and health related attitudes and knowledge about specific diseases

    directly after intervention and at six months follow-up

  • general self-efficacy expectation

    directly after intervention and at six months follow-up

Study Arms (2)

Manualized RELIANCE intervention

EXPERIMENTAL

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

Non-manualized socio-legal counseling

ACTIVE COMPARATOR

two socio-legal counseling sessions delivered by a social worker

Behavioral: socio-legal counseling

Interventions

Return to work and living healthy after head and neck cancerBEHAVIORAL

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

Manualized RELIANCE intervention
socio-legal counselingBEHAVIORAL

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

Non-manualized socio-legal counseling

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Leipzig

Leipzig, Saxony, 04103, Germany

Location

Related Links

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Return to Work

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

EmploymentSocioeconomic FactorsPopulation Characteristics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Open Label
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

February 17, 2017

First Posted

February 28, 2017

Study Start

January 1, 2017

Primary Completion

September 30, 2018

Study Completion

December 31, 2018

Last Updated

November 5, 2020

Record last verified: 2020-11

Locations

DE(1)