Mindfulness in Endometrial and Cervical Cancer
MECCA
Mindfulness Practice in Endometrial and Cervical Cancers With Smartphone Applications (MECCA)
1 other identifier
interventional
120
1 country
1
Brief Summary
Patients with endometrial cancer who will be undergoing surgery or patients with cervical cancer who will be treated with chemoradiation will be randomized to utilize the Headspace smartphone application or not prior to their anticipated treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 25, 2020
CompletedFirst Submitted
Initial submission to the registry
July 26, 2020
CompletedFirst Posted
Study publicly available on registry
August 13, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2026
CompletedSeptember 30, 2025
September 1, 2025
6 years
July 26, 2020
September 26, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Opiate Usage-Endometrial cancer
The amount of opiates used during the acute (30 day) recovery after surgery for endometrial cancer or acute treatment with chemoradiation for cervical cancer will be recorded.
Enrollment to 30 days post op for endometrial cancer.
Opiate Usage-Cervical Cancer
The amount of opiates used during the acute treatment with chemoradiation for cervical cancer will be recorded.
Enrollment to 6 weeks post treatment for cervical cancer.
Secondary Outcomes (5)
Five Facet Mindfulness Questionnaire
Enrollment to 4 weeks post op for endometrial cancer. Enrollment to 6 weeks post treatment for cervical cancer.
Functional Assessment of Cancer Therapy-General
Enrollment to 4 weeks post op for endometrial cancer. Enrollment to 6 weeks post treatment for cervical cancer.
Complication Rates
Enrollment to 4 weeks post op for endometrial cancer. Enrollment to 6 weeks post treatment for cervical cancer.
Patient satisfaction
Enrollment to 4 weeks post op for endometrial cancer. Enrollment to 6 weeks post treatment for cervical cancer.
Compliance
Enrollment to 4 weeks post op for endometrial cancer. Enrollment to 6 weeks post treatment for cervical cancer.
Study Arms (2)
Intervention
EXPERIMENTALPatients with endometrial cancer will be approached for participation at their pre-operative visit. Patients with cervical cancer will be approached at their pre-treatment visit. If the patient opts to participate, she will be randomized to utilize the Headspace smartphone application or not. She will be provided a three month gift subscription. Headspace will be downloaded to her smartphone and she will be instructed on use. Patients will be asked to complete a quality of life survey on the day of enrollment, the day of surgery (endometrial cancer) or first brachytherapy (cervical cancer) and at their post-treatment visit. The patient will receive one phone call prior to her post-treatment visit requesting she bring her bottle of opiate pills with her for counting. The number of pills used will be recorded. The number of Headspace sessions will be recorded. An anonymous survey will be provided for completion. The patient will be provided a gift card at completion.
Control
NO INTERVENTIONPatients with endometrial cancer will be approached for participation at their pre-operative visit. Patients with cervical cancer will be approached at their pre-treatment visit. If the patient opts to participate, she will be randomized to utilize the Headspace smartphone application or not. All patients in the control group may choose to practice calming or mindfulness exercises of their own accord but will not be specifically instructed to seek out such resources as is our standard practice. Patients will be asked to complete a quality of life survey on the day of enrollment, the day of surgery (endometrial cancer) or first brachytherapy (cervical cancer) and at their post-treatment visit. The patient will receive one phone call prior to her post-treatment visit requesting she bring her bottle of opiate pills with her for counting. The number of pills used will be recorded. An anonymous survey will be provided for completion. The patient will be provided a gift card at completion.
Interventions
Headspace is a smartphone application used for mindfulness, meditation, and stress reduction. It has been utilized in other behavioral and quality of life studies.
Eligibility Criteria
You may qualify if:
- New diagnosis of either 1) endometrial cancer undergoing surgery or 2) cervical cancer undergoing chemo-sensitizing radiation
- Access to a smartphone
You may not qualify if:
- Non-English speaking
- No access to smartphone
- Current use of Headspace application
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Saint Louis University
St Louis, Missouri, 63104, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shannon Grabosch, MD
St. Louis University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Gynecologic Oncology
Study Record Dates
First Submitted
July 26, 2020
First Posted
August 13, 2020
Study Start
July 25, 2020
Primary Completion
July 30, 2026
Study Completion
July 30, 2026
Last Updated
September 30, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share