Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2026-02-25 @ 5:22 PM
Study NCT ID:
NCT03065634
Status:
TERMINATED
Last Update Posted:
2020-11-05
First Post:
2017-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Return to Work and Living Healthy After Head and Neck Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D062707', 'term': 'Return to Work'}], 'ancestors': [{'id': 'D004651', 'term': 'Employment'}, {'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Open Label'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'whyStopped': 'insufficient recruitment rate', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-03', 'studyFirstSubmitDate': '2017-02-17', 'studyFirstSubmitQcDate': '2017-02-22', 'lastUpdatePostDateStruct': {'date': '2020-11-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Work ability', 'timeFrame': 'directly after intervention and at six months follow-up', 'description': 'Work-Ability-Index, short version (WAI)'}, {'measure': 'Pattern of work-related coping behaviour', 'timeFrame': 'directly after intervention and at six months follow-up', 'description': 'Pattern of work-related coping behaviour, short Version (AVEM-44)'}], 'secondaryOutcomes': [{'measure': 'Cancer-specific health-related quality of Life (global, functioning, symptom burden)', 'timeFrame': 'directly after intervention and at six months follow-up', 'description': 'Quality of Life Core Questionnaire of the European Organisation for Research and Treatment of Cancer (EORTC-QLQ-C30)'}, {'measure': 'Quality of life and symptoms specific to head and neck cancer', 'timeFrame': 'directly after intervention and at six months follow-up', 'description': 'Head and Neck Module of the European Organisation for Research and Treatment of Cancer (EORTC-H\\&N35)'}, {'measure': 'anxiety, depression and psychological distress in patients with somatic diseases', 'timeFrame': 'directly after intervention and at six months follow-up', 'description': 'Hospital Anxiety and Depression Scale (HADS)'}, {'measure': 'health behavior and health related attitudes and knowledge about specific diseases', 'timeFrame': 'directly after intervention and at six months follow-up', 'description': 'questionnaire measuring health behavior and health related attitudes and knowledge about specific diseases (FEG)'}, {'measure': 'general self-efficacy expectation', 'timeFrame': 'directly after intervention and at six months follow-up', 'description': 'general self-efficacy expectation (ASKU)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Head and Neck Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://medpsy.uniklinikum-leipzig.de/medpsych.site,postext,projekte-psychoonkologie-aktuell,a_id,8222.html', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of laryngea, hypopharyngeal, oropharyngeal, tonsil or base of the tongue cancer within the last six months\n* Curative treatment\n* Completion of primary and follow-up Treatment\n* Fluency in German\n* Written informed and voluntary consent\n* Psychological distress (Distress Thermometer score \\> 4)\n* Self-perceived prognosis of employment (SPE score ≥ 1)\n\nExclusion Criteria:\n\n* Alcohol dependency with physical withdrawal symptoms (CAGE score ≥ 3 and current use of alcohol)\n* Acute suicidal tendencies\n* Receiving old-age pension or will receive old-age pension within the next 12 months\n* Cognitive impairment indicated in the medical records or by the attending doctor\n* Being in psychotherapy'}, 'identificationModule': {'nctId': 'NCT03065634', 'acronym': 'RELIANCE', 'briefTitle': 'Return to Work and Living Healthy After Head and Neck Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Leipzig'}, 'officialTitle': 'Return to Work and Living Healthy After Head and Neck Cancer', 'orgStudyIdInfo': {'id': '93000-133'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Manualized RELIANCE 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.', 'interventionNames': ['Behavioral: Return to work and living healthy after head and neck cancer']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Non-manualized socio-legal counseling', 'description': 'two socio-legal counseling sessions delivered by a social worker', 'interventionNames': ['Behavioral: socio-legal counseling']}], 'interventions': [{'name': 'Return to work and living healthy after head and neck cancer', 'type': 'BEHAVIORAL', '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', 'armGroupLabels': ['Manualized RELIANCE intervention']}, {'name': 'socio-legal counseling', 'type': 'BEHAVIORAL', 'description': 'Non-manualized socio-legal counseling\n\ntwo socio-legal counseling sessions delivered by a social worker', 'armGroupLabels': ['Non-manualized socio-legal counseling']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04103', 'city': 'Leipzig', 'state': 'Saxony', 'country': 'Germany', 'facility': 'University Medical Center Leipzig', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Leipzig', 'class': 'OTHER'}, 'collaborators': [{'name': 'Universitätsklinikum Leipzig', 'class': 'OTHER'}, {'name': 'Jena University Hospital', 'class': 'OTHER'}, {'name': 'Klinikum St. Georg gGmbH', 'class': 'OTHER'}, {'name': 'Stadtisches Klinikum Dresden', 'class': 'OTHER'}, {'name': 'German Cancer Aid', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr.', 'investigatorFullName': 'Anja Mehnert', 'investigatorAffiliation': 'University of Leipzig'}}}}