Mind-body Online Therapy in Gynecological Oncology

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

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.

Study Overview

• Status: Recruiting
• Conditions: Gynecologic Cancer
• Intervention / Treatment: Other: Mind-Body Online Therapy

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • St.Gallen, Switzerland, 9007
    • Recruiting
    • Clinic for Psychosomatic Medicine and Consultation-Liaison Psychiatry
    • Contact: Katja H H Keller; Phone Number: +41714941727; Email: katja.haemmerlikeller@kssg.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mind-Body Online Therapy	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.
No Intervention: TAU (treatment as usual)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Katja Haemmerli Keller
• Collaborators: University of Bern

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): August 31, 2024

Study Registration Dates

• First Submitted: March 11, 2022
• First Submitted That Met QC Criteria: March 29, 2022
• First Posted (Actual): April 6, 2022

Study Record Updates

• Last Update Posted (Actual): September 6, 2023
• Last Update Submitted That Met QC Criteria: September 2, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Cancer; Oncology; Gynecology; Psychotherapy; Body; Online Therapy; Psychosomatics; Mind; MBM; Mind Body Medicin; Online-Therapie; Internettherapie; Internet Therapy; Selbsthilfeintervention; Onkologie; Krebs; Gynäkologie; Frauenklinik; Frauenheilkunde; Psychosomatik; Psychotherapie
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 2022-00174

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No