Clinical trial · Interventional
The SERENITY Study: Online Mindfulness-Based Cancer Recovery for Patients With Gynecological Cancer
Online Mindfulness-Based Cancer Recovery (MBCR) Program for Patients Living With a Gynecological Cancer: a Pilot Randomized Controlled Study.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The overall objective of this project is to explore the feasibility, acceptability and potential effects of the online MBCR program in gynecological cancer settings. This will provide preliminary efficacy data in prevision of a larger, confirmatory, randomized controlled trial. As this study will be one of the first led in a French speaking country and the first conducted in a university hospital environment in Switzerland, the investigators would like to investigate the early implementation of this program among professionals and patients. Furthermore, they will investigate if in the online MBCR group, participants will show improvement in psychosocial outcomes, consumption of psychotropic and opioid medication, spirituality and meaning in life and in different biological processes.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gynecologic Cancer | Malignant Female Reproductive System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Online Mindfulness-Based Cancer Recovery (MBCR) | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention group
- description
- Online Mindfulness-Based Cancer Recovery
- interventionNames
- Behavioral: Online Mindfulness-Based Cancer Recovery (MBCR)
- type
- NO_INTERVENTION
- label
- Control group
- description
- Treatment as usual
Primary outcomes (1)
- measure
- Participants' attendance to the program
- timeFrame
- Within 3 weeks of completion of the intervention
- description
- Number of overall sessions attended - patients are expected to attend at least 5 of the 10 sessions planned (including the 6-h retreat)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * ≥ 18 years * Being a woman * Being diagnosed with breast or any gynecological cancer (either ovarian, cervical, vulvar, womb or vaginal cancer), stages I to IV. * For women with localized cancers: having completed all adjuvant treatments, such as surgery, chemotherapy and/or radiotherapy, at least 3 months previously, with the exception of hormonal, immune and targeted therapy, * For women with metastatic cancers: having a performance status \< 3, not undergoing IV chemotherapy and having a life expectancy more than 9 months as estimated by their treating oncologist. * Free from acute infection for 2 weeks before biochemical assessment. * Speaking and reading French fluently * Be able to follow the online course via a computer/tablet Exclusion Criteria: * Inability to follow the procedures of the study due to: * Significant deafness * Physical impairment that prevents attending the sessions * Mental retardation (ICD-10) * Dementia (ICD-10) * Depression (ICD-10) \* * Spectrum disorder of schizophrenia (ICD-10) \*\* * Alcohol or other substance dependence (ICD-10) \*\* * Emotionally labile personality disorder that is incompatible with group participation (ICD-10) \*\* * A post-traumatic stress disorder (PTSD) (ICD-10)\*\* * Currently engages in meditation one or more times per week * Previous participation in an MBI program * Serious physiological illnesses that would interfere with the interpretation of biochemical data (e.g., anemia, diabetes, cardiovascular diseases, blood cancers, inflammatory bowel diseases, autoimmune diseases, asthma being treated with steroids, immunodeficiency)
References
Publications (1)
- DERIVEDGaignard ME, Martin D, Stanic J, Hilfiker R, Bodmer A, Ljuslin M, Zaman K, Labidi-Galy I, Sarivalasis A, Carlson LE, Peters S, Dietrich PY, Eicher M, Bondolfi G, Jermann F. The Experience of Women With Breast or Gynecological Cancer After Participation in an Online Mindfulness-Based Cancer Recovery (e-MBCR) Program: Secondary Outcomes Analysis of a Pilot Mixed Methods Randomized Controlled Trial. Psychooncology. 2025 Nov;34(11):e70334. doi: 10.1002/pon.70334. PMID 41272951