Online mind-body therapy for gynecological cancer patients
Mind-body Online Therapy in a Somatic Setting - a Randomized-controlled, Two-arm, Monocentric Study in Gynecological Oncology
NA · Cantonal Hospital of St. Gallen · NCT05313724
This study tests whether an online therapy program can help women recently diagnosed with gynecological cancer feel better and manage their health.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Cantonal Hospital of St. Gallen (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (St.Gallen) |
| Trial ID | NCT05313724 on ClinicalTrials.gov |
What this trial studies
This randomized-controlled study examines the effectiveness and feasibility of an internet-based, therapist-guided mind-body self-help intervention for patients recently diagnosed with gynecological cancer. The intervention includes various modules focusing on relaxation, mindfulness, stress management, disease management, nutrition, and exercise behaviors. The study aims to improve or maintain the quality of life for participants through structured online therapy sessions. Patients will be assessed at three different time points to evaluate the intervention's impact.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have been recently diagnosed with gynecological cancer and are within the first 12 weeks of their first-line treatment.
Not a fit: Patients with moderate to severe depressive symptoms or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly enhance the quality of life for gynecological cancer patients during their treatment.
How similar studies have performed: Other studies have shown promising results with mind-body interventions in cancer care, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
St.Gallen
- Clinic for Psychosomatic Medicine and Consultation-Liaison Psychiatry — St.Gallen, Switzerland (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Gynecologic Cancer, Mind, Body, MBM, Mind Body Medicin, Online Therapy, Online-Therapie, Internettherapie