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

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ClinicalTrials.gov Identifier: NCT03065634
Recruitment Status : Recruiting
First Posted : February 28, 2017
Last Update Posted : February 28, 2017
Sponsor:
Collaborators:
Universitätsklinikum Leipzig
Jena University Hospital
Klinikum St. Georg gGmbH
Städtisches Klinikum Dresden
German Cancer Aid
Information provided by (Responsible Party):
Anja Mehnert, University of Leipzig

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.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Behavioral: Return to work and living healthy after head and neck cancer Behavioral: socio-legal counseling Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: Open Label
Primary Purpose: Treatment
Official Title: Return to Work and Living Healthy After Head and Neck Cancer
Actual Study Start Date : January 1, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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




Primary Outcome Measures :
  1. Work ability [ Time Frame: directly after intervention and at six months follow-up ]
    Work‐Ability‐Index, short version (WAI)

  2. Pattern of work-related coping behaviour [ Time Frame: directly after intervention and at six months follow-up ]
    Pattern of work-related coping behaviour, short Version (AVEM-44)


Secondary Outcome Measures :
  1. Quality of Life [ Time Frame: directly after intervention and at six months follow-up ]
    Quality of Life Core Questionnaire of the European Organisation for Research and Treatment of Cancer (EORTC-QLQ-C30)

  2. Quality of life and symptoms specific to head and neck cancer [ Time Frame: directly after intervention and at six months follow-up ]
    Head and Neck Module of the European Organisation for Research and Treatment of Cancer (EORTC‐H&N35)

  3. anxiety, depression and psychological distress in patients with somatic diseases [ Time Frame: directly after intervention and at six months follow-up ]
    Hospital Anxiety and Depression Scale (HADS)

  4. health behavior and health related attitudes and knowledge about specific diseases [ Time Frame: directly after intervention and at six months follow-up ]
    questionnaire measuring health behavior and health related attitudes and knowledge about specific diseases (FEG)

  5. general self-efficacy expectation [ Time Frame: directly after intervention and at six months follow-up ]
    general self-efficacy expectation (ASKU)



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03065634


Contacts
Contact: Laura Broemer, MSc +49-(0)341-9718816 Laura.Broemer@medizin.uni-leipzig.de
Contact: Judith Keszte, Diploma +49-(0)341-9715463 judith.keszte@medizin.uni-leipzig.de

Locations
Germany
University Medical Center Leipzig Recruiting
Leipzig, Saxony, Germany, 04103
Contact: Anja Mehnert, PhD         
Sponsors and Collaborators
University of Leipzig
Universitätsklinikum Leipzig
Jena University Hospital
Klinikum St. Georg gGmbH
Städtisches Klinikum Dresden
German Cancer Aid

Additional Information:
Responsible Party: Anja Mehnert, Prof. Dr., University of Leipzig
ClinicalTrials.gov Identifier: NCT03065634     History of Changes
Other Study ID Numbers: 93000-133
First Posted: February 28, 2017    Key Record Dates
Last Update Posted: February 28, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms