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

NCT04564768 | Completed DMC

• 1 other identifier: 2019-00965
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 2

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

Keywords

Online Mindfulness-Based Cancer Recovery

Outcome Measures

Primary Outcomes (1)

• Participants' attendance to the program

  Number of overall sessions attended - patients are expected to attend at least 5 of the 10 sessions planned (including the 6-h retreat)

  Within 3 weeks of completion of the intervention

Secondary Outcomes (27)

• Acceptability of the program (quantitative)

  Every week during the intervention and within 3 weeks of completion of the intervention

• Acceptability of the program (qualitative)

  Every week during the intervention and within 3 weeks of completion of the intervention

• Appropriateness of the program (quantitative)

  Within 3 weeks of completion of the intervention

• Appropriateness of the program (qualitative)

  Within 3 weeks of completion of the intervention

• Fidelity of the program

  Within 3 weeks of completion of the intervention

Study Arms (2)

Intervention group

EXPERIMENTAL

Online Mindfulness-Based Cancer Recovery

Behavioral: Online Mindfulness-Based Cancer Recovery (MBCR)

Control group

NO INTERVENTION

Treatment as usual

Interventions

Online Mindfulness-Based Cancer Recovery (MBCR) 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.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (2)

Hôpitaux Universitaires de Genève (HUG)

Geneva, Switzerland

Location

Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, Switzerland

Location

Related Publications (1)

• Gaignard ME, Martin D, Stanic J, Hilfiker R, Bodmer A, Ljuslin M, Zaman K, Labidi-Galy I, Sarivalasis A, Carlson LE, Peters S, Dietrich PY, Eicher M, Bondolfi G, Jermann F. The Experience of Women With Breast or Gynecological Cancer After Participation in an Online Mindfulness-Based Cancer Recovery (e-MBCR) Program: Secondary Outcomes Analysis of a Pilot Mixed Methods Randomized Controlled Trial. Psychooncology. 2025 Nov;34(11):e70334. doi: 10.1002/pon.70334.

  PMID: 41272951 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A randomized controlled pilot study including qualitative and quantitative elements.

Study Record Dates

• First Submitted: August 22, 2020
• First Posted: September 25, 2020
• Study Start: December 19, 2019
• Primary Completion: June 30, 2022
• Study Completion: September 30, 2022
• Last Updated: November 29, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (2)