University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53705, United States
NCT Number: NCT02518308
This pilot clinical trial studies how well a mindfulness-based stress reduction (MBSR) intervention works in reducing anxiety in patients who have undergone treatment for gynecologic cancer but no longer have any sign of disease. Gynecologic cancer is cancer of the female reproductive tract, which includes the cervix, endometrium, fallopian tubes, ovaries, uterus, and vagina. Side effects from treatment for these cancers may include anxiety, fatigue, depression, and sexual function changes. Mindfulness training uses meditation and yoga to help patients focus on breathing, bodily sensations, and mental awareness. This may help decrease patients' stress and anxiety and improve their quality of life, and may also help their immune system.
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Notify Me18 year and older
Female
Interventional
Not applicable
Madison, Wisconsin, 53705, United States
Patients are randomized to 1 of 2 Arms.
ARM I (INTERVENTION): Patients undergo an 8-week MBSR course, comprising weekly 2.5 hour classes and one 6-hour Saturday class at week 6 or 7. The MBSR program involves instruction in mindfulness meditation and yoga, and gives homework assignments involving practicing the well-being techniques taught in class. Patients are required to record and report time spent on home practice in a journal daily, and receive a weekly reminder to report their home practice.
ARM II (WAIT-LIST CONTROL): Patients do not participate in the intervention, but are given the option to be placed on a waitlist for the MBSR course and may complete it within 6 months after the final study visit.
After completion of study, patients are followed up at 8 weeks (at completion of study) and 5 months (3 months from study completion).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The Mindfulness-Based Stress Reduction program involves instruction in mindfulness meditation and yoga.
Other names: MBSR
Time frame: Baseline to up to 5 months
Measured by the 8-item anxiety subscale of the PROMIS scale.
Time frame: Baseline to up to 5 months
Measured by PROMIS subscale for depression.
Time frame: Baseline to up to 5 months
Measured by PROMIS subscale for fatigue.
Time frame: Baseline to up to 5 months
Measured by PROMIS subscale for sleep disturbance.
Time frame: Baseline to up to 5 months
Measured by Female Sexual Function Profile and Global Satisfaction with Sex Life questionnaire.
Time frame: Baseline to up to 5 months
measured by Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being Scale (FACIT-SP-12 version 4)
Time frame: Baseline to up to 5 months
Measured by the NIH Toolbox Assessments
Time frame: Baseline to up to 5 months
The biobehavioral link between MBSR intervention-related Quality of Life changes and immune cell function will be explored.
Time frame: Baseline to up to 5 months
The biobehavioral link between MBSR intervention-related Quality of Life changes and immune cell function will be explored.
Time frame: Baseline to up to 5 months
The biobehavioral link between MBSR intervention-related Quality of Life changes and immune cell function will be explored.
Time frame: Baseline to up to 5 months
The biobehavioral link between MBSR intervention-related Quality of Life changes and immune cell function will be explored.
University of Wisconsin, Madison
Other
Mindfulness-Based Interventions in Patients Treated for Gynecologic Cancer - Impact on Patient Reported Outcomes and Immunologic Correlates
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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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