Brief Title
Mindfulness in Endometrial and Cervical Cancer
Official Title
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
Interventional
Primary Outcome
Opiate Usage-Endometrial cancer
Secondary Outcome
Five Facet Mindfulness Questionnaire
Condition
Gynecologic Cancer
Intervention
Headspace Smartphone Application
Study Arms / Comparison Groups
Intervention
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Behavioral
Estimated Enrollment
120
Start Date
July 25, 2020
Completion Date
July 30, 2023
Primary Completion Date
July 30, 2023
Eligibility Criteria
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
Gender
Female
Ages
18 Years - 90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Shannon Grabosch, MD, 3147818605, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT04512144
Organization ID
30780
Responsible Party
Principal Investigator
Study Sponsor
St. Louis University
Study Sponsor
Shannon Grabosch, MD, Principal Investigator, St. Louis University
Verification Date
February 2022