Clinical trial NCT05313724: Mind-body Online Therapy in Gynecological Oncology
Official title: Mind-body Online Therapy in a Somatic Setting - a Randomized-controlled, Two-arm, Monocentric Study in Gynecological Oncology
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gynecologic Cancer
Keywords: Mind
Body
MBM
Mind Body Medicin
Online Therapy
Online-Therapie
Internettherapie
Internet Therapy
Selbsthilfeintervention
Onkologie
Oncology
Krebs
Cancer
Gynäkologie
Gynecology
Frauenklinik
Frauenheilkunde
Psychosomatik
Psychosomatics
Psychotherapie
Psychotherapy
Lead sponsor: Cantonal Hospital of St. Gallen
Sponsor class: OTHER
Collaborators: name: University of Bern
First posted: 2022-04-06
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 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 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

Primary outcomes:
measure: Anxiety and depression
timeFrame: Changes between week 0, 8, 16
measure: Depression (external assessment)
timeFrame: Changes between week 0, 8, 16
measure: Somatization
timeFrame: Changes between week 0, 8, 16
measure: General distress
timeFrame: Week 0, Week 8, Week 16
measure: Psychological stress
timeFrame: Changes between week 0, 8, 16
measure: Impairment from cancer therapy
timeFrame: Changes between week 0, 8, 16
measure: Insomnia (Severity)
timeFrame: Changes between week 0, 8, 16
measure: Sleep quality
timeFrame: Changes between week 0, 8, 16
measure: Health-related quality of life
timeFrame: Changes between week 0, 8, 16
measure: SpO2 [%]
timeFrame: Changes between week 0, 8, 16
measure: Peripheral arterial tone (PAT) [mmHG]
timeFrame: Changes between week 0, 8, 16
Secondary outcomes:
measure: Feasibility of the intervention (Patient-therapist relationship)
timeFrame: Changes between week 8, 16
measure: Feasibility of the intervention (Usability)
timeFrame: Changes between week 8, 16
measure: Feasibility of the intervention (Patient satisfaction)
timeFrame: Changes between week 8, 16
Other outcomes:
Locations:
city: St.Gallen
country: Switzerland
facility: Clinic for Psychosomatic Medicine and Consultation-Liaison Psychiatry
Study officials:
References: