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

NCT ID: NCT04564768

Last Updated: 2022-11-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-19
• Study Completion Date: 2022-09-30

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.

Conditions

Gynecologic Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Intervention group

Online Mindfulness-Based Cancer Recovery

Group Type: EXPERIMENTAL

Online Mindfulness-Based Cancer Recovery (MBCR)

Intervention Type: BEHAVIORAL

Mindfulness-Based Cancer Recovery (MBCR) is a standardized group program which focuses primarily on the challenges faced by people living with cancer. It is an 8-week program consisting of weekly group meetings of 1.5 to 2 hours. Home practice of 45 minutes per day (15 min yoga; 30 min meditation) is prescribed. As the weeks progress, different forms of meditation are introduced, beginning with a body scan sensory awareness experience, progressing to sitting and walking meditations. Gentle Hatha yoga is incorporated throughout, as a form of moving meditation. Didactic instruction as well as group discussion and reflection, problem solving and skillful inquiry are commonly applied teaching tools.

Control group

Treatment as usual

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Online Mindfulness-Based Cancer Recovery (MBCR)

Mindfulness-Based Cancer Recovery (MBCR) is a standardized group program which focuses primarily on the challenges faced by people living with cancer. It is an 8-week program consisting of weekly group meetings of 1.5 to 2 hours. Home practice of 45 minutes per day (15 min yoga; 30 min meditation) is prescribed. As the weeks progress, different forms of meditation are introduced, beginning with a body scan sensory awareness experience, progressing to sitting and walking meditations. Gentle Hatha yoga is incorporated throughout, as a form of moving meditation. Didactic instruction as well as group discussion and reflection, problem solving and skillful inquiry are commonly applied teaching tools.

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Geneva

OTHER

Sponsor Role: lead

Responsible Party

Marie-Estelle Gaignard

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hôpitaux Universitaires de Genève (HUG)

Geneva, , Switzerland

Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, , Switzerland

Countries

Switzerland

Other Identifiers

2019-00965

Identifier Type: -

Identifier Source: org_study_id