Psychological interventions for breast cancer survivors
The Effectiveness of Mobile-based Psychological Interventions in Reducing Psychological Distress and Preventing Stress-related Changes in Psycho-neuroendocrine-immune Network in Breast Cancer Survivors- Randomized Controlled Trial
This study is testing whether three different online mental health programs can help breast cancer survivors feel better and improve their stress levels.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 440 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Masaryk University Academic / other |
| Locations | 1 site (Brno, Bohunice) |
| Trial ID | NCT05406531 on ClinicalTrials.gov |
What this trial studies
This study examines the effectiveness of three different psychological interventions delivered through a mobile application on the psycho-neuroendocrine-immune system in breast cancer survivors. Researchers will measure the impact of these interventions on various stress-related biomarkers, including cortisol and heart rate variability, as well as psychological variables. The study aims to provide clearer outcomes by recruiting a homogeneous sample of patients and conducting follow-up measurements at 3 and 9 months. The interventions include Mindfulness-Based Cognitive Therapy, Positive Psychology, and Autogenic Training, all provided online.
Who should consider this trial
Good fit: Ideal candidates for this study are women over the age of 18 who have completed adjuvant treatment for breast cancer.
Not a fit: Patients with severe psychiatric disorders or those lacking access to mobile devices or the internet may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the psychological and immune health of breast cancer survivors, potentially improving their overall well-being.
How similar studies have performed: Previous studies have shown promising results for psychological interventions in cancer care, but this specific approach using mobile applications is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* Women over the age of 18
* Breast cancer patients at the end of adjuvant treatment
Exclusion Criteria:
* Patients without a mobil device ("smart" mobile phone)
* Patients without internet access
* Patients with diagnosed: psychotic disorder; severe depressive episode; panic disorder; bipolar disorder; personality disorder associated with uncontrollable mood swings; PTSD; suicidal attempts and active suicidal ideation; disability pension due to non-specific mental or somatic problems; hospitalization due to a psychiatric disorder in the past year
Where this trial is running
Brno, Bohunice
- Faculty of Medicine, Masaryk University — Brno, Bohunice, Czechia (Recruiting)
Study contacts
- Study coordinator: Miroslav Světlák, PhD.
- Email: msvetlak@med.muni.cz
- Phone: +420 549 49 1372
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.