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Mindfulness in Endometrial and Cervical Cancer (MECCA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04512144
Recruitment Status : Recruiting
First Posted : August 13, 2020
Last Update Posted : February 21, 2022
Sponsor:
Information provided by (Responsible Party):
Shannon Grabosch, MD, St. Louis University

Tracking Information
First Submitted Date  ICMJE July 26, 2020
First Posted Date  ICMJE August 13, 2020
Last Update Posted Date February 21, 2022
Actual Study Start Date  ICMJE July 25, 2020
Estimated Primary Completion Date July 30, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 10, 2020)
  • Opiate Usage-Endometrial cancer [ Time Frame: Enrollment to 30 days post op for 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.
  • Opiate Usage-Cervical Cancer [ Time Frame: Enrollment to 6 weeks post treatment for cervical cancer. ]
    The amount of opiates used during the acute treatment with chemoradiation for cervical cancer will be recorded.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 10, 2020)
  • Five Facet Mindfulness Questionnaire [ Time Frame: Enrollment to 4 weeks post op for endometrial cancer. Enrollment to 6 weeks post treatment for cervical cancer. ]
    Patients will be asked to complete a Five Facet Mindfulness Questionnaire form at enrollment, on the day of surgery (endometrial cancer) or first brachytherapy (cervical cancer), and at their post-treatment visit.
  • Functional Assessment of Cancer Therapy-General [ Time Frame: Enrollment to 4 weeks post op for endometrial cancer. Enrollment to 6 weeks post treatment for cervical cancer. ]
    Patients will be asked to complete a Functional Assessment of Cancer Therapy-General form at enrollment, on the day of surgery (endometrial cancer) or first brachytherapy (cervical cancer), and at their post-treatment visit.
  • Complication Rates [ Time Frame: Enrollment to 4 weeks post op for endometrial cancer. Enrollment to 6 weeks post treatment for cervical cancer. ]
    Surgical or treatment complications will be monitored in each group.
  • Patient satisfaction [ Time Frame: Enrollment to 4 weeks post op for endometrial cancer. Enrollment to 6 weeks post treatment for cervical cancer. ]
    Patients from each group will be asked to complete an anonymous study-specific survey evaluating their satisfaction with the program.
  • Compliance [ Time Frame: Enrollment to 4 weeks post op for endometrial cancer. Enrollment to 6 weeks post treatment for cervical cancer. ]
    The number of Headspace sessions utilized by patients in the intervention group will be recorded.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mindfulness in Endometrial and Cervical Cancer
Official Title  ICMJE Mindfulness Practice in Endometrial and Cervical Cancers With Smartphone Applications (MECCA)
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.
Detailed Description

A diagnosis of cancer can be a major stress-inducing event. The prevalence of depression in patients diagnosed with cancer is estimated up to 16%. Practicing mindfulness is a cost-effective treatment which can also help manage treatment adverse effects and cancer-related symptoms.

Even short exposure and practice of mindfulness exercises have demonstrated improved subjective and objective measurements of stress and anxiety with breast biopsies. Patients with breast cancer also have improved quality of life with mindfulness training. Self-guided mindfulness with smartphone applications, specifically the app Headspace, has been associated with positive benefits and ease of use in the general population and among cancer patients.

A patient's inherent level of baseline mindfulness has been associated with lower pain scores following minimally invasive hysterectomy. This study did not specifically encourage practice of mindfulness exercises. Our own study of post-operative opiate usage in women following minimally invasive hysterectomy contains self-reported data of women using opiates to relax or help sleep. This suggests that mindfulness exercises may improve quality of life in these areas and thus reduce opiate usage. Patients undergoing minimally invasive hysterectomy for treatment of endometrial cancer were specifically chosen as a study cohort to build on our own data and that currently reported in the literature as well as the highest incidence of this cancer as a gynecologic malignancy. The second study cohort chosen was women with cervical cancer undergoing definitive treatment with chemo-sensitizing radiation given the significant endeavor required for complete treatment. Additionally, these women are often younger with the diagnosis of cervical cancer often being their first major medical diagnosis.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Gynecologic Cancer
  • Endometrial Cancer
  • Cervical Cancer
  • Quality of Life
  • Opioid Use
Intervention  ICMJE Behavioral: Headspace Smartphone Application
Headspace is a smartphone application used for mindfulness, meditation, and stress reduction. It has been utilized in other behavioral and quality of life studies.
Study Arms  ICMJE
  • Experimental: Intervention
    Patients 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.
    Intervention: Behavioral: Headspace Smartphone Application
  • No Intervention: Control
    Patients 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 10, 2020)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 30, 2023
Estimated Primary Completion Date July 30, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • New diagnosis of either 1) endometrial cancer undergoing surgery or 2) cervical cancer undergoing chemo-sensitizing radiation
  • Access to a smartphone

Exclusion Criteria:

  • Non-English speaking
  • No access to smartphone
  • Current use of Headspace application
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Shannon Grabosch, MD 3147818605 ext 1 shannon.grabosch@health.slu.edu
Contact: Shohreh Jamalabadi-Majidi, DMD, MPH 3149777482 shohreh.jamalabadimajidi@health.slu.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04512144
Other Study ID Numbers  ICMJE 30780
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Shannon Grabosch, MD, St. Louis University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE St. Louis University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Shannon Grabosch, MD St. Louis University
PRS Account St. Louis University
Verification Date February 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP