Mind-body Online Therapy in Gynecological Oncology

Gynecologic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05313724
• Other study ID #: 2022-00174
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: August 31, 2024

Study information

• Verified date: September 2023
• Source: Cantonal Hospital of St. Gallen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: August 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gynecologic Cancer
• Neoplasms

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Switzerland	Clinic for Psychosomatic Medicine and Consultation-Liaison Psychiatry	St.Gallen

Sponsors (2)

Lead Sponsor	Collaborator
Katja Haemmerli Keller	University of Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Depression (external assessment)	German version of the questionnaire "Hamilton Depression Scale" (HAM-D17; Hamilton, 1960; Hamilton, 1986)	Changes between week 0, 8, 16
Primary	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
Primary	General distress	German version of the questionnaire "Distress Thermometer" (BTH; Mehnert et al., 2006)	Week 0, Week 8, Week 16
Primary	Psychological stress	German version of the questionnaire "Symptom Checklist" (SCL-K11; Franke, 2001; Franke, 2002)	Changes between week 0, 8, 16
Primary	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
Primary	Insomnia (Severity)	German version of the questionnaire "Insomnia Severity Index" (ISI; Morin, 1993)	Changes between week 0, 8, 16
Primary	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
Primary	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
Primary	SpO2 [%]	Sleep diagnostic system "WatchPAT" (Neumedpro, Neuwirth Medical Products, 2021)	Changes between week 0, 8, 16
Primary	Peripheral arterial tone (PAT) [mmHG]	Sleep diagnostic system "WatchPAT" (Neumedpro, Neuwirth Medical Products, 2021)	Changes between week 0, 8, 16
Secondary	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
Secondary	Feasibility of the intervention (Usability)	German version of the questionnaire "System Usability Scale" (SUS; Brooke, 1996)	Changes between week 8, 16
Secondary	Feasibility of the intervention (Patient satisfaction)	German questionnaire "Patient Satisfaction" (ZUF-8; Schmidt & Wittmann, 2002)	Changes between week 8, 16