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Mindfulness App for Gynecologic Cancers (MECCA Trial)

N/A

Recruiting

Led By Shannon Grabosch, MD

Research Sponsored by St. Louis University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

New diagnosis of either 1) endometrial cancer undergoing surgery or 2) cervical cancer undergoing chemo-sensitizing radiation

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up enrollment to 4 weeks post op for endometrial cancer. enrollment to 6 weeks post treatment for cervical cancer.

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether the Headspace smartphone app can help reduce stress in patients with endometrial or cervical cancer.

Who is the study for?

This trial is for English-speaking individuals newly diagnosed with endometrial cancer scheduled for surgery, or cervical cancer to be treated with chemoradiation. Participants must have access to a smartphone and not currently use the Headspace app.

What is being tested?

The study is testing if using the Headspace smartphone application can improve quality of life in patients undergoing treatment for endometrial or cervical cancer. Patients are randomly chosen to either use the app or not before their treatment starts.

What are the potential side effects?

Since this trial involves a mindfulness app, there are no direct medical side effects expected from its use. However, participants may experience varying levels of engagement or psychological impact.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am newly diagnosed with endometrial or cervical cancer and will undergo surgery or radiation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ enrollment to 4 weeks post op for endometrial cancer. enrollment to 6 weeks post treatment for cervical cancer.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~enrollment to 4 weeks post op for endometrial cancer. enrollment to 6 weeks post treatment for cervical cancer.

This trial's timeline: 3 weeks for screening, Varies for treatment, and enrollment to 4 weeks post op for endometrial cancer. enrollment to 6 weeks post treatment for cervical cancer. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Opiate Usage-Cervical Cancer

Opiate Usage-Endometrial cancer

Secondary study objectives

Compliance

Complication Rates

Five Facet Mindfulness Questionnaire

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: InterventionExperimental Treatment1 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.

Group II: ControlActive Control1 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. 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.

0 / 1Eligibility criteria met