The SERENITY Study: Online Mindfulness-Based Cancer Recovery for Patients With Gynecological Cancer

University Hospitals (UH)

Status

Completed

Conditions

Gynecologic Cancer

Treatments

Behavioral: Online Mindfulness-Based Cancer Recovery (MBCR)

Study type

Interventional

Funder types

Other

Identifiers

NCT04564768

2019-00965

Details and patient eligibility

About

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.

Enrollment

62 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)