Mindfulness in Endometrial and Cervical Cancer

Part of paid clinical trials in St Louis, Missouri.

Sponsor
St. Louis University
Study ID
NCT04512144
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 90 Years
Healthy Volunteers
Accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Jul 25, 2020
Status verified
Sep 2025
Primary completion
Jul 30, 2026
Completion
Jul 30, 2026

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

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.

Primary Outcome Measure

Opiate Usage-Endometrial cancer [ Time Frame: Enrollment to 30 days post op for endometrial cancer. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Saint Louis UniversitySt LouisMissouri63104
Shannon Grabosch, MD
[email protected]
314-781-8605

Find similar trials in St Louis, MO

By condition
Cervical cancerEndometrial cancerSubstance use disorder
By specialty
OncologyGynecologic oncologyWomen's healthBehavioral healthAddiction medicine
By research site
Saint Louis University· St Louis, MO

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