Mind-body Online Therapy in Gynecological Oncology

Study Overview
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Brief Summary
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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.

Official Title
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Mind-body Online Therapy in a Somatic Setting - a Randomized-controlled, Two-arm, Monocentric Study in Gynecological Oncology

Conditions
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Gynecologic Cancer

Intervention / Treatment
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* Other: Mind-Body Online Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 18 years old Oncologic disease: first diagnosed; within the first 12 weeks of diagnosis, first-line treatment (either systemic treatment - including chemotherapy, hormonal therapy or targeted therapy - or radiotherapy), Notes: (1) Patients treated for first recurrence of a tumor previously treated with curative intent are also eligible. (2) Psychological distress is taken into account by stratification according to the stress thermometer. In research, this procedure corresponds to the current state-of-the-art. Individual subgroups (e.g. cancer stages) can then be studied post-hoc. Sufficient computer skills and internet access Availability of an emergency address Written informed consent by signing the informed consent form Exclusion Criteria: Patient unable to provide written informed consent by signing informed consent form Insufficient knowledge of German Moderate to severe depressive symptomatology (BDI > 18; HAM-D17 ≥ 17) during T1 survey Suicidality (BDI suicidality item > 1; HAM-D17 suicidality item ≥ 2) in the context of the T1 survey Diagnosis of psychotic, bipolar, or other serious mental or somatic disorder requiring immediate treatment Male breast cancer patients

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mind-Body Online Therapy<br> | Other: Mind-Body Online Therapy<br>* 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.<br>|
| No Intervention: TAU (treatment as usual)<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MBM, Mind, Body, Mind Body Medicin, Online Therapy, Online-Therapie, Internettherapie, Internet Therapy, Selbsthilfeintervention, Onkologie, Oncology, Krebs, Cancer, Gynäkologie, Gynecology, Frauenklinik, Frauenheilkunde, Psychosomatik, Psychosomatics, Psychotherapie, Psychotherapy