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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
39
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
University Medical Center Leipzig
Leipzig, Saxony, Germany
Work ability
Work-Ability-Index, short version (WAI)
Time frame: 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)
Time frame: directly after intervention and at six months follow-up
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)
Time frame: directly after intervention and at six months follow-up
Quality of life and symptoms specific to head and neck cancer
Head and Neck Module of the European Organisation for Research and Treatment of Cancer (EORTC-H\&N35)
Time frame: 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)
Time frame: 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)
Time frame: directly after intervention and at six months follow-up
general self-efficacy expectation
general self-efficacy expectation (ASKU)
Time frame: directly after intervention and at six months follow-up
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