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insufficient recruitment rate
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| Name | Class |
|---|---|
| Universitätsklinikum Leipzig | OTHER |
| Jena University Hospital | OTHER |
| Klinikum St. Georg gGmbH | OTHER |
| Stadtisches Klinikum Dresden |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Non-manualized socio-legal counseling | Active Comparator | two socio-legal counseling sessions delivered by a social worker |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Return to work and living healthy after head and neck cancer | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | directly after intervention and at six months follow-up |
| Quality of life and symptoms specific to head and neck cancer |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Leipzig | Leipzig | Saxony | 04103 | Germany |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D062707 | Return to Work |
| ID | Term |
|---|---|
| D004651 | Employment |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
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| OTHER |
| German Cancer Aid | OTHER |
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Open Label
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|
| socio-legal counseling | Behavioral | Non-manualized socio-legal counseling two socio-legal counseling sessions delivered by a social worker |
|
Head and Neck Module of the European Organisation for Research and Treatment of Cancer (EORTC-H&N35) |
| directly after intervention and at six months follow-up |
| anxiety, depression and psychological distress in patients with somatic diseases | Hospital Anxiety and Depression Scale (HADS) | directly after intervention and at six months follow-up |
| 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) | directly after intervention and at six months follow-up |
| general self-efficacy expectation | general self-efficacy expectation (ASKU) | directly after intervention and at six months follow-up |