Mindfulness in Endometrial and Cervical Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-90
SponsorSt. Louis University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
New diagnosis of either 1) endometrial cancer undergoing surgery or 2) cervical cancer undergoing chemo-sensitizing radiation
Access to a smartphone
Disqualifiers
Non-English speaking
No access to smartphone
Current use of Headspace application
Trial design
Design model
Parallel
Treatments tested in this trial
Headspace Smartphone Application
BehavioralHeadspace is a smartphone application used for mindfulness, meditation, and stress reduction. It has been utilized in other behavioral and quality of life studies.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: InterventionExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Opiate Usage-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.
Time frame
Enrollment to 30 days post op for endometrial cancer.2
Opiate Usage-Cervical Cancer
The amount of opiates used during the acute treatment with chemoradiation for cervical cancer will be recorded.
Time frame
Enrollment to 6 weeks post treatment for cervical cancer.Secondary outcomes
1
Five Facet Mindfulness Questionnaire
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.
Time frame
Enrollment to 4 weeks post op for endometrial cancer. Enrollment to 6 weeks post treatment for cervical cancer.2
Functional Assessment of Cancer Therapy-General
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.
Time frame
Enrollment to 4 weeks post op for endometrial cancer. Enrollment to 6 weeks post treatment for cervical cancer.3
Complication Rates
Surgical or treatment complications will be monitored in each group.
Time frame
Enrollment to 4 weeks post op for endometrial cancer. Enrollment to 6 weeks post treatment for cervical cancer.4
Patient satisfaction
Patients from each group will be asked to complete an anonymous study-specific survey evaluating their satisfaction with the program.
Time frame
Enrollment to 4 weeks post op for endometrial cancer. Enrollment to 6 weeks post treatment for cervical cancer.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov