Status:
UNKNOWN
Mind-body Online Therapy in Gynecological Oncology
Lead Sponsor:
Katja Haemmerli Keller
Collaborating Sponsors:
University of Bern
Conditions:
Gynecologic Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
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 fo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2024
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT05313724
Start Date
July 1 2022
End Date
August 31 2024
Last Update
September 6 2023
Active Locations (1)
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1
Clinic for Psychosomatic Medicine and Consultation-Liaison Psychiatry
Sankt Gallen, Switzerland, 9007