Return to Work and Living Healthy After Head and Neck Cancer

NCT ID: NCT03065634

Last Updated: 2020-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-01

Study Completion Date

2018-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Head and Neck Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Open Label

Study Groups

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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.

Group Type EXPERIMENTAL

Return to work and living healthy after head and neck cancer

Intervention Type BEHAVIORAL

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

Non-manualized socio-legal counseling

two socio-legal counseling sessions delivered by a social worker

Group Type ACTIVE_COMPARATOR

socio-legal counseling

Intervention Type BEHAVIORAL

Non-manualized socio-legal counseling

two socio-legal counseling sessions delivered by a social worker

Interventions

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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

Intervention Type BEHAVIORAL

socio-legal counseling

Non-manualized socio-legal counseling

two socio-legal counseling sessions delivered by a social worker

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Universitätsklinikum Leipzig

OTHER

Sponsor Role collaborator

Jena University Hospital

OTHER

Sponsor Role collaborator

Klinikum St. Georg gGmbH

OTHER

Sponsor Role collaborator

Stadtisches Klinikum Dresden

OTHER

Sponsor Role collaborator

German Cancer Aid

OTHER

Sponsor Role collaborator

University of Leipzig

OTHER

Sponsor Role lead

Responsible Party

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Anja Mehnert

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Medical Center Leipzig

Leipzig, Saxony, Germany

Site Status

Countries

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Germany

Related Links

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Other Identifiers

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93000-133

Identifier Type: -

Identifier Source: org_study_id