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| Name | Class |
|---|---|
| University of Bern | OTHER |
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In this randomized-controlled two-arm monocentric study with three measurement time points, the effectiveness and feasibility of an internet-based, therapist-guided mind-body self-help intervention for gynecological cancer patients with primary diagnoses is examined. Different modules (e.g., relaxation, mindfulness, stress management, disease management, nutrition and exercise behaviors) with a mind-body focus are available for the patients. The goal of the intervention is to improve or maintain the quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mind-Body Online Therapy | Experimental |
| |
| TAU (treatment as usual) | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mind-Body Online Therapy | Other | There are 8 different modules (e.g. relaxation, mindfulness, stress management, disease management, nutrition and exercise behavior) with a mind-body focus available for the patients to independently (time, location) work on. |
| Measure | Description | Time Frame |
|---|---|---|
| Anxiety and depression | German version of the questionnaire "Hospital Anxiety and Depression Scale" (HADS; (Herrmann et al., 1995; Herrmann-Lingen et al., 2011) | Changes between week 0, 8, 16 |
| Depression (external assessment) | German version of the questionnaire "Hamilton Depression Scale" (HAM-D17; Hamilton, 1960; Hamilton, 1986) | Changes between week 0, 8, 16 |
| Somatization | German version of the questionnaire "Patient Health Questionnaire" (PHQ-9; Gräfe et al., 2004; Kroenke et al., 2010) | Changes between week 0, 8, 16 |
| General distress | German version of the questionnaire "Distress Thermometer" (BTH; Mehnert et al., 2006) | Week 0, Week 8, Week 16 |
| Psychological stress | German version of the questionnaire "Symptom Checklist" (SCL-K11; Franke, 2001; Franke, 2002) | Changes between week 0, 8, 16 |
| Impairment from cancer therapy | German version of the questionnaire "Functional Assessment of Cancer Therapy" (FACT-G; Cella & Bonomi, 1996; Cella et al., 1993) | Changes between week 0, 8, 16 |
| Insomnia (Severity) | German version of the questionnaire "Insomnia Severity Index" (ISI; Morin, 1993) | Changes between week 0, 8, 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of the intervention (Patient-therapist relationship) | German version of the questionnaire "Working Alliance Inventory - Short Revised" (WAI-SR; Wilmers et al., 2008) | Changes between week 8, 16 |
| Feasibility of the intervention (Usability) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinic for Psychosomatic Medicine and Consultation-Liaison Psychiatry | Recruiting | Sankt Gallen | 9007 | Switzerland |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| Sleep quality | German version of the questionnaire "Pittsburgh Sleep Quality Index" (PSQI; Buysse et al., 1989; Carpenter & Andrykowski, 1998) | Changes between week 0, 8, 16 |
| Health-related quality of life | German version of the questionnaire "Short Form 12" (SF-12; Morfeld et al., 2012) | Changes between week 0, 8, 16 |
| SpO2 [%] | Sleep diagnostic system "WatchPAT" (Neumedpro, Neuwirth Medical Products, 2021) | Changes between week 0, 8, 16 |
| Peripheral arterial tone (PAT) [mmHG] | Sleep diagnostic system "WatchPAT" (Neumedpro, Neuwirth Medical Products, 2021) | Changes between week 0, 8, 16 |
German version of the questionnaire "System Usability Scale" (SUS; Brooke, 1996)
| Changes between week 8, 16 |
| Feasibility of the intervention (Patient satisfaction) | German questionnaire "Patient Satisfaction" (ZUF-8; Schmidt & Wittmann, 2002) | Changes between week 8, 16 |