Mindfulness in Endometrial and Cervical Cancer

Quality of Life Clinical Trial

— MECCA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04512144
• Other study ID #: 30780
• Status: Recruiting
• Phase: N/A
• Start date: July 25, 2020
• Est. completion date: July 30, 2024

Study information

• Verified date: September 2023
• Source: St. Louis University
• Contact: Shannon Grabosch, MD
• Phone: 3147818605
• Email: shannon.grabosch[@]health.slu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: July 30, 2024
• Est. primary completion date: July 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• Endometrial Cancer
• Endometrial Neoplasms
• Gynecologic Cancer
• Opioid Use
• Quality of Life
• Uterine Cervical Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Saint Louis University	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
St. Louis University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.