Headspace Smartphone Application for Endometrial Cancer
Saint Louis University, Saint Louis, MO
Targeting 5 different conditionsHeadspace Smartphone ApplicationN/ARecruitingLed by Shannon Grabosch, MDResearch Sponsored by St. Louis UniversityEligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Access to a smartphone
New diagnosis of either 1) endometrial cancer undergoing surgery or 2) cervical cancer undergoing chemo-sensitizing radiation
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upenrollment to 4 weeks post op for endometrial cancer. enrollment to 6 weeks post treatment for cervical cancer.
Awards & highlights
No Placebo-Only Group
Study Summary
This trial will test whether the Headspace smartphone app can help reduce stress in patients with endometrial or cervical cancer.
Eligible Conditions
- Endometrial Cancer
- Gynecologic Cancers
- Cervical Cancer
- Quality of Life
- Opioid Use Disorder
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You need to have a smartphone.
Select...
You have recently been diagnosed with either endometrial or cervical cancer and are currently receiving treatment through surgery or chemo-sensitizing 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.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Opiate Usage-Cervical Cancer
Opiate Usage-Endometrial cancer
Secondary outcome measures
Compliance
Complication Rates
Five Facet Mindfulness Questionnaire
+2 moreAwards & 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.
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Who is running the clinical trial?
St. Louis UniversityLead Sponsor
190 Previous Clinical Trials
42,397 Total Patients Enrolled
1 Trials studying Endometrial Cancer
83 Patients Enrolled for Endometrial Cancer
Shannon Grabosch, MDPrincipal Investigator - St. Louis University
SSM St. Mary's Health Center, St. Louis University Hospital, St. Luke's Hospital
1 Previous Clinical Trials
83 Total Patients Enrolled
1 Trials studying Endometrial Cancer
83 Patients Enrolled for Endometrial Cancer
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there open spots for participants in this scientific experiment?
"Affirmative. Clinicaltrials.gov indicates that this medical study, which originated on July 25th 2020, is currently enrolling patients and looking to recruit 120 participants from a single location."
Answered by AI
How many subjects are partaking in this experiment?
"That is correct. Referring to clinicaltrials.gov, we can see that the trial was first put up on July 25th 2020 and it has been recently updated on February 18th 2022. The research project requires 120 individuals from a single centre."
Answered by AI
What key goals is this research endeavor attempting to achieve?
"This clinical trial will be evaluated over a time-frame extending from enrolment to 6 weeks after treatment for [cervical cancer](https://www.withpower.com/clinical-trials/cervical-cancer), and opiate usage in endometrial cancer. Secondary objectives include the completion of Functional Assessment of Cancer Therapy-General forms at various points during the study, patient satisfaction surveys, and monitoring complication rates among both groups."
Answered by AI
Is the upper age limit for this experimentation open to those over 45 years old?
"This experiment is inviting volunteers aged 18 and older, but no more than 90 years old."
Answered by AI
Who has the opportunity to be a participant in this investigation?
"Criteria for enrollment in this clinical trial is strict: the patient must have endometrial neoplasms and be between 18-90 years old. The team behind this study hopes to recruit roughly 120 patients."
Answered by AI