Mind-body Online Therapy in Gynecological Oncology

Last updated: September 2, 2023
Sponsor: Katja Haemmerli Keller
Overall Status: Active - Recruiting

Phase

N/A

Condition

Vaginal Cancer

Pelvic Cancer

Neoplasms

Treatment

Mind-Body Online Therapy

Clinical Study ID

NCT05313724
2022-00174
  • Ages > 18
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • At least 18 years old
  • Oncologic disease: first diagnosed; within the first 12 weeks of diagnosis, first-linetreatment (either systemic treatment - including chemotherapy, hormonal therapy ortargeted therapy - or radiotherapy), Notes: (1) Patients treated for first recurrenceof a tumor previously treated with curative intent are also eligible. (2)Psychological distress is taken into account by stratification according to the stressthermometer. 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

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 ofthe T1 survey
  • Diagnosis of psychotic, bipolar, or other serious mental or somatic disorder requiringimmediate treatment
  • Male breast cancer patients

Study Design

Total Participants: 120
Treatment Group(s): 1
Primary Treatment: Mind-Body Online Therapy
Phase:
Study Start date:
July 01, 2022
Estimated Completion Date:
August 31, 2024

Connect with a study center

  • Clinic for Psychosomatic Medicine and Consultation-Liaison Psychiatry

    St.Gallen, 9007
    Switzerland

    Active - Recruiting

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