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NCT Number: NCT04512144

Mindfulness in Endometrial and Cervical Cancer

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.

Recruiting

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Key information

Age range

18 year–90 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Saint Louis University

St Louis, Missouri, 63104, United States

Location status: Recruiting

Location contact

Shannon Grabosch, MD

CONTACT

[email protected]

314-781-8605 ext. 1

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Headspace Smartphone Application

Behavioral

Headspace is a smartphone application used for mindfulness, meditation, and stress reduction. It has been utilized in other behavioral and quality of life studies.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Shannon Grabosch, MD

CONTACT

[email protected]

3147818605 ext. 1

Shohreh Jamalabadi-Majidi, DMD, MPH

CONTACT

[email protected]

3149777482

Sponsors and collaborators

Lead sponsor

St. Louis University

Other

Registry information

Official study title

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

Acronym: MECCA

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Aug 13, 2020
Registry last updated
Sep 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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