Mindfulness in Endometrial and Cervical Cancer (MECCA)

Mindfulness Practice in Endometrial and Cervical Cancers With Smartphone Applications (MECCA)

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.

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Cervical Cancer; Gynecologic Cancer; Endometrial Cancer; Opioid Use
• Intervention / Treatment: Behavioral: Headspace Smartphone Application

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
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shannon Grabosch, MD; Phone Number: 1 3147818605; Email: shannon.grabosch@health.slu.edu
• Study Contact Backup: Name: Shohreh Jamalabadi-Majidi, DMD, MPH; Phone Number: 3149777482; Email: shohreh.jamalabadimajidi@health.slu.edu

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63104
      • Recruiting
      • Saint Louis University
      • Contact: Shannon Grabosch, MD; Phone Number: 1 314-781-8605; Email: shannon.grabosch@health.slu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Five Facet Mindfulness Questionnaire	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.	Enrollment to 4 weeks post op for endometrial cancer. Enrollment to 6 weeks post treatment for cervical cancer.
Functional Assessment of Cancer Therapy-General	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.	Enrollment to 4 weeks post op for endometrial cancer. Enrollment to 6 weeks post treatment for cervical cancer.
Complication Rates	Surgical or treatment complications will be monitored in each group.	Enrollment to 4 weeks post op for endometrial cancer. Enrollment to 6 weeks post treatment for cervical cancer.
Patient satisfaction	Patients from each group will be asked to complete an anonymous study-specific survey evaluating their satisfaction with the program.	Enrollment to 4 weeks post op for endometrial cancer. Enrollment to 6 weeks post treatment for cervical cancer.
Compliance	The number of Headspace sessions utilized by patients in the intervention group will be recorded.	Enrollment to 4 weeks post op for endometrial cancer. Enrollment to 6 weeks post treatment for cervical cancer.

Collaborators and Investigators

• Sponsor: St. Louis University
• Investigators: Principal Investigator: Shannon Grabosch, MD, St. Louis University

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2020
• Primary Completion (Estimated): July 30, 2024
• Study Completion (Estimated): July 30, 2024

Study Registration Dates

• First Submitted: July 26, 2020
• First Submitted That Met QC Criteria: August 10, 2020
• First Posted (Actual): August 13, 2020

Study Record Updates

• Last Update Posted (Actual): September 11, 2023
• Last Update Submitted That Met QC Criteria: September 8, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Uterine Cervical Neoplasms; Endometrial Neoplasms
• Other Study ID Numbers: 30780

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No