Clinical trial NCT04564768: The SERENITY Study: Online Mindfulness-Based Cancer Recovery for Patients With Gynecological Cancer
Official title: Online Mindfulness-Based Cancer Recovery (MBCR) Program for Patients Living With a Gynecological Cancer: a Pilot Randomized Controlled Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gynecologic Cancer
Keywords: Online Mindfulness-Based Cancer Recovery
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2020-09-25
Enrollment: 62
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized controlled pilot study including qualitative and quantitative elements.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Participants' attendance to the program
timeFrame: Within 3 weeks of completion of the intervention
Secondary outcomes:
measure: Acceptability of the program (quantitative)
timeFrame: Every week during the intervention and within 3 weeks of completion of the intervention
measure: Acceptability of the program (qualitative)
timeFrame: Every week during the intervention and within 3 weeks of completion of the intervention
measure: Appropriateness of the program (quantitative)
timeFrame: Within 3 weeks of completion of the intervention
measure: Appropriateness of the program (qualitative)
timeFrame: Within 3 weeks of completion of the intervention
measure: Fidelity of the program
timeFrame: Within 3 weeks of completion of the intervention
measure: Adoption of the program (from participants' perspectives)
timeFrame: Organizational: within 3 weeks of completion of the intervention ; participants: 3-month follow up from intervention completion
measure: Adoption of the program (from professionals' perspectives)
timeFrame: Organizational: within 3 weeks of completion of the intervention ; participants: 3-month follow up from intervention completion
measure: Costs of the program
timeFrame: Pre-intervention, within 3 weeks of completion of the intervention, 3-month follow up from intervention completion
measure: Time to recruit, recruitment, retention rates, reasons for non-participation and acceptability of data collection
timeFrame: Pre-intervention, within 3 weeks of completion of the intervention, 3-month follow up from intervention completion
measure: Acceptability of the study processes
timeFrame: Pre-intervention, within 3 weeks of completion of the intervention, 3-month follow up from intervention completion
measure: Patients' experience related to the online MBCR program and the study design
timeFrame: Within 3 weeks of completion of the intervention
measure: State and Trait Anxiety Inventory Form Y (STAI-Y)
timeFrame: Pre-intervention, within 3 weeks of completion of the intervention, 3-month follow up from intervention completion
measure: Major Depression Inventory (MDI)
timeFrame: Pre-intervention, within 3 weeks of completion of the intervention, 3-month follow up from intervention completion
measure: Five Facet Mindfulness Questionnaire (FFMQ)
timeFrame: Pre-intervention, within 3 weeks of completion of the intervention, 3-month follow up from intervention completion
measure: Sleep Condition Indicator (SCI)
timeFrame: Pre-intervention, within 3 weeks of completion of the intervention, 3-month follow up from intervention completion
measure: Posttraumatic Growth Inventory - Revised (PTGI-R)
timeFrame: Pre-intervention, within 3 weeks of completion of the intervention, 3-month follow up from intervention completion
measure: Self-Compassion Scale (SCS)
timeFrame: Pre-intervention, within 3 weeks of completion of the intervention, 3-month follow up from intervention completion
measure: Fear of Cancer Recurrence Inventory (FCRI)
timeFrame: Pre-intervention, within 3 weeks of completion of the intervention, 3-month follow up from intervention completion
measure: Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
timeFrame: Pre-intervention, within 3 weeks of completion of the intervention, 3-month follow up from intervention completion
measure: Functional Assessment of Chronic Illness Therapy Spiritual Well-Being (FACIT-Sp12)
timeFrame: Pre-intervention, within 3 weeks of completion of the intervention, 3-month follow up from intervention completion
measure: Immune cells count
timeFrame: Pre-intervention, within 3 weeks of completion of the intervention, 3-month follow up from intervention completion
measure: Circulating pro-inflammatory markers (1)
timeFrame: Pre-intervention, within 3 weeks of completion of the intervention, 3-month follow up from intervention completion
measure: Circulating pro-inflammatory markers (2)
timeFrame: Pre-intervention, within 3 weeks of completion of the intervention, 3-month follow up from intervention completion
measure: Gene expression of pro-inflammatory genes
timeFrame: Pre-intervention, within 3 weeks of completion of the intervention, 3-month follow up from intervention completion
measure: Telomerase activity
timeFrame: Pre-intervention, within 3 weeks of completion of the intervention, 3-month follow up from intervention completion
measure: Telomere length
timeFrame: Pre-intervention, within 3 weeks of completion of the intervention, 3-month follow up from intervention completion
measure: Methylation of inflammatory genes
timeFrame: Pre-intervention, within 3 weeks of completion of the intervention, 3-month follow up from intervention completion
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Hôpitaux Universitaires de Genève (HUG)
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois (CHUV)
Study officials:
References: