Recruiting

Mindfulness

Sponsor:

St. Louis University

Code:

NCT04512144

Conditions

Gynecologic Cancer

Endometrial Cancer

Cervical Cancer

Quality of Life

Opioid Use

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Headspace Smartphone Application

Study Details

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.

Conditions

Gynecologic Cancer

Endometrial Cancer

Cervical Cancer

Quality of Life

Opioid Use

Study ID

NCT04512144

Start date

Jul 25, 2020

Status verified date

Sep, 2025

Completion date

Jul 30, 2026

Anticipated

Primary completion date

Jul 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Accepted

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 Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

Primary outcome measure

  • Opiate Usage-Endometrial cancer [ Time Frame: Enrollment to 30 days post op for endometrial cancer. ]
  • Opiate Usage-Cervical Cancer [ Time Frame: Enrollment to 6 weeks post treatment for cervical cancer. ]

Central Contacts and Locations

Central contacts

Locations

Saint Louis University

Recruiting

St Louis, Missouri, United States, 63104

Contacts

More Information

Sponsor

St. Louis University

Last update posted

Sep 30, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by St. Louis University on 2025-09-30.