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 enrollmentDecember 19, 2019

ConditionsGynecologic Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Gynecologic Cancer
Sponsor: University Hospital, Geneva
Enrollment: 62
Locations: 2
Primary Endpoint: Participants' attendance to the program
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

December 19, 2019

End Date

September 30, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

University Hospital, Geneva

Responsible Party

Principal Investigator

Marie-Estelle Gaignard

Principal Investigator

University Hospital, Geneva

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)\*\*

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)
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)
Fidelity of the program(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)
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)
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)