Mind-body Online Therapy in Gynecological Oncology

Katja Haemmerli Keller120 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

120

Conditions

Gynecologic Cancer

Interventions

Mind-Body Online TherapyOTHER

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.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Clinic for Psychosomatic Medicine and Consultation-Liaison Psychiatry

Sankt Gallen, Switzerland

RECRUITING

Outcomes

Primary Outcomes

Anxiety and depression

German version of the questionnaire "Hospital Anxiety and Depression Scale" (HADS; (Herrmann et al., 1995; Herrmann-Lingen et al., 2011)