JOURNAL ONKOLOGIE – STUDIE

Mind-body Online Therapy in Gynecological Oncology

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT05313724

Studienbeginn:
Juli 2022

Letztes Update:
06.09.2023

Wirkstoff:
-

Indikation (Clinical Trials):
Neoplasms

Geschlecht:
Frauen

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Katja Haemmerli Keller

Collaborator:
University of Bern

Studienlocations
(1 von 1)

Clinic for Psychosomatic Medicine and Consultation-Liaison Psychiatry
9007 St.Gallen
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Katja H H Keller
Phone: +41714941727
E-Mail: katja.haemmerlikeller@kssg.ch» Ansprechpartner anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. Anxiety and depression (Time Frame - 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)

2. Depression (external assessment) (Time Frame - Changes between week 0, 8, 16):
German version of the questionnaire "Hamilton Depression Scale" (HAM-D17; Hamilton, 1960; Hamilton, 1986)

3. Somatization (Time Frame - Changes between week 0, 8, 16):
German version of the questionnaire "Patient Health Questionnaire" (PHQ-9; Gräfe et al., 2004; Kroenke et al., 2010)

4. General distress (Time Frame - Week 0, Week 8, Week 16):
German version of the questionnaire "Distress Thermometer" (BTH; Mehnert et al., 2006)

5. Psychological stress (Time Frame - Changes between week 0, 8, 16):
German version of the questionnaire "Symptom Checklist" (SCL-K11; Franke, 2001; Franke, 2002)

6. Impairment from cancer therapy (Time Frame - 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)

7. Insomnia (Severity) (Time Frame - Changes between week 0, 8, 16):
German version of the questionnaire "Insomnia Severity Index" (ISI; Morin, 1993)

8. Sleep quality (Time Frame - Changes between week 0, 8, 16):
German version of the questionnaire "Pittsburgh Sleep Quality Index" (PSQI; Buysse et al., 1989; Carpenter & Andrykowski, 1998)

9. Health-related quality of life (Time Frame - Changes between week 0, 8, 16):
German version of the questionnaire "Short Form 12" (SF-12; Morfeld et al., 2012)

10. SpO2 [%] (Time Frame - Changes between week 0, 8, 16):
Sleep diagnostic system "WatchPAT" (Neumedpro, Neuwirth Medical Products, 2021)

11. Peripheral arterial tone (PAT) [mmHG] (Time Frame - Changes between week 0, 8, 16):
Sleep diagnostic system "WatchPAT" (Neumedpro, Neuwirth Medical Products, 2021)

Secondary outcome:

1. Feasibility of the intervention (Patient-therapist relationship) (Time Frame - Changes between week 8, 16):
German version of the questionnaire "Working Alliance Inventory - Short Revised" (WAI-SR; Wilmers et al., 2008)

2. Feasibility of the intervention (Usability) (Time Frame - Changes between week 8, 16):
German version of the questionnaire "System Usability Scale" (SUS; Brooke, 1996)

3. Feasibility of the intervention (Patient satisfaction) (Time Frame - Changes between week 8, 16):
German questionnaire "Patient Satisfaction" (ZUF-8; Schmidt & Wittmann, 2002)

Studien-Arme

Experimental: Mind-Body Online Therapy
No Intervention: TAU (treatment as usual)

Geprüfte Regime

Mind-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.

Quelle: ClinicalTrials.gov

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