Mind-body Online Therapy in Gynecological Oncology

Katja Haemmerli Keller

Status

Enrolling

Conditions

Gynecologic Cancer

Treatments

Other: Mind-Body Online Therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT05313724

2022-00174

Details and patient eligibility

About

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.

Enrollment

120 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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