Gynecologic Cancer
Conditions
Keywords
Mind, Body, MBM, Mind Body Medicin, Online Therapy, Online-Therapie, Internettherapie, Internet Therapy, Selbsthilfeintervention, Onkologie, Oncology, Krebs, Cancer, Gynäkologie, Gynecology, Frauenklinik, Frauenheilkunde, Psychosomatik, Psychosomatics, Psychotherapie, Psychotherapy
Brief summary
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.
Interventions
OTHERMind-Body Online Therapy
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.
Sponsors
University of Bern
Katja Haemmerli Keller
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peripheral arterial tone (PAT) [mmHG] | Changes between week 0, 8, 16 | Sleep diagnostic system WatchPAT (Neumedpro, Neuwirth Medical Products, 2021) |
| Sleep quality | Changes between week 0, 8, 16 | German version of the questionnaire Pittsburgh Sleep Quality Index (PSQI; Buysse et al., 1989; Carpenter & Andrykowski, 1998) |
| Health-related quality of life | Changes between week 0, 8, 16 | German version of the questionnaire Short Form 12 (SF-12; Morfeld et al., 2012) |
| SpO2 [%] | Changes between week 0, 8, 16 | Sleep diagnostic system WatchPAT (Neumedpro, Neuwirth Medical Products, 2021) |
| Anxiety and depression | Changes between week 0, 8, 16 | German version of the questionnaire Hospital Anxiety and Depression Scale (HADS; (Herrmann et al., 1995; Herrmann-Lingen et al., 2011) |
| Depression (external assessment) | Changes between week 0, 8, 16 | German version of the questionnaire Hamilton Depression Scale (HAM-D17; Hamilton, 1960; Hamilton, 1986) |
| Somatization | Changes between week 0, 8, 16 | German version of the questionnaire Patient Health Questionnaire (PHQ-9; Gräfe et al., 2004; Kroenke et al., 2010) |
| General distress | Week 0, Week 8, Week 16 | German version of the questionnaire Distress Thermometer (BTH; Mehnert et al., 2006) |
| Psychological stress | Changes between week 0, 8, 16 | German version of the questionnaire Symptom Checklist (SCL-K11; Franke, 2001; Franke, 2002) |
| Impairment from cancer therapy | Changes between week 0, 8, 16 | German version of the questionnaire Functional Assessment of Cancer Therapy (FACT-G; Cella & Bonomi, 1996; Cella et al., 1993) |
| Insomnia (Severity) | Changes between week 0, 8, 16 | German version of the questionnaire Insomnia Severity Index (ISI; Morin, 1993) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of the intervention (Usability) | Changes between week 8, 16 | German version of the questionnaire System Usability Scale (SUS; Brooke, 1996) |
| Feasibility of the intervention (Patient satisfaction) | Changes between week 8, 16 | German questionnaire Patient Satisfaction (ZUF-8; Schmidt & Wittmann, 2002) |
| Feasibility of the intervention (Patient-therapist relationship) | Changes between week 8, 16 | German version of the questionnaire Working Alliance Inventory - Short Revised (WAI-SR; Wilmers et al., 2008) |
Countries
Switzerland
Outcome results
None listed