NCT04564768CompletedNot Applicable
Online Mindfulness-Based Cancer Recovery (MBCR) Program for Patients Living With a Gynecological Cancer: a Pilot Randomized Controlled Study.
University Hospital, Geneva2 sites in 1 country62 target enrollmentStarted: December 19, 2019Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University Hospital, Geneva
- Enrollment
- 62
- Locations
- 2
- Primary Endpoint
- Participants' attendance to the program
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
Intervention group
Experimental
Online Mindfulness-Based Cancer Recovery
Intervention: Online Mindfulness-Based Cancer Recovery (MBCR) (Behavioral)
Control group
No Intervention
Treatment as usual
Outcomes
Primary Outcomes
Participants' attendance to the program
Time Frame: Within 3 weeks of completion of the intervention
Number of overall sessions attended - patients are expected to attend at least 5 of the 10 sessions planned (including the 6-h retreat)
Secondary Outcomes
- Adoption of the program (from professionals' perspectives)(Organizational: within 3 weeks of completion of the intervention ; participants: 3-month follow up from intervention completion)
- Fidelity of the program(Within 3 weeks of completion of the intervention)
- Immune cells count(Pre-intervention, within 3 weeks of completion of the intervention, 3-month follow up from intervention completion)
- Circulating pro-inflammatory markers (2)(Pre-intervention, within 3 weeks of completion of the intervention, 3-month follow up from intervention completion)
- Acceptability of the study processes(Pre-intervention, within 3 weeks of completion of the intervention, 3-month follow up from intervention completion)
- Gene expression of pro-inflammatory genes(Pre-intervention, within 3 weeks of completion of the intervention, 3-month follow up from intervention completion)
- Telomerase activity(Pre-intervention, within 3 weeks of completion of the intervention, 3-month follow up from intervention completion)
- Acceptability of the program (qualitative)(Every week during the intervention and within 3 weeks of completion of the intervention)
- Acceptability of the program (quantitative)(Every week during the intervention and within 3 weeks of completion of the intervention)
- Appropriateness of the program (qualitative)(Within 3 weeks of completion of the intervention)
- Adoption of the program (from participants' perspectives)(Organizational: within 3 weeks of completion of the intervention ; participants: 3-month follow up from intervention completion)
- Time to recruit, recruitment, retention rates, reasons for non-participation and acceptability of data collection(Pre-intervention, within 3 weeks of completion of the intervention, 3-month follow up from intervention completion)
- Major Depression Inventory (MDI)(Pre-intervention, within 3 weeks of completion of the intervention, 3-month follow up from intervention completion)
- Appropriateness of the program (quantitative)(Within 3 weeks of completion of the intervention)
- Costs of the program(Pre-intervention, within 3 weeks of completion of the intervention, 3-month follow up from intervention completion)
- Patients' experience related to the online MBCR program and the study design(Within 3 weeks of completion of the intervention)
- State and Trait Anxiety Inventory Form Y (STAI-Y)(Pre-intervention, within 3 weeks of completion of the intervention, 3-month follow up from intervention completion)
- Five Facet Mindfulness Questionnaire (FFMQ)(Pre-intervention, within 3 weeks of completion of the intervention, 3-month follow up from intervention completion)
- Sleep Condition Indicator (SCI)(Pre-intervention, within 3 weeks of completion of the intervention, 3-month follow up from intervention completion)
- Fear of Cancer Recurrence Inventory (FCRI)(Pre-intervention, within 3 weeks of completion of the intervention, 3-month follow up from intervention completion)
- Posttraumatic Growth Inventory - Revised (PTGI-R)(Pre-intervention, within 3 weeks of completion of the intervention, 3-month follow up from intervention completion)
- Self-Compassion Scale (SCS)(Pre-intervention, within 3 weeks of completion of the intervention, 3-month follow up from intervention completion)
- Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)(Pre-intervention, within 3 weeks of completion of the intervention, 3-month follow up from intervention completion)
- Functional Assessment of Chronic Illness Therapy Spiritual Well-Being (FACIT-Sp12)(Pre-intervention, within 3 weeks of completion of the intervention, 3-month follow up from intervention completion)
- Circulating pro-inflammatory markers (1)(Pre-intervention, within 3 weeks of completion of the intervention, 3-month follow up from intervention completion)
- Telomere length(Pre-intervention, within 3 weeks of completion of the intervention, 3-month follow up from intervention completion)
- Methylation of inflammatory genes(Pre-intervention, within 3 weeks of completion of the intervention, 3-month follow up from intervention completion)
Investigators
Marie-Estelle Gaignard
Principal Investigator
University Hospital, Geneva
Study Sites (2)
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