NCT02518308

Mindfulness Intervention in Reducing Anxiety in Patients Who Have Been Treated for Gynecologic Cancer

Mindfulness-Based Interventions in Patients Treated for Gynecologic Cancer - Impact on Patient Reported Outcomes and Immunologic Correlates

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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).

Conditions

• Anxiety
• Cancer Survivor
• Cognitive Impairment
• Depression
• Distress
• Fatigue
• Malignant Female Reproductive System Neoplasm
• Pain
• Sexual Dysfunction

Interventions

Type	Name	Description
BEHAVIORAL	Mindfulness-Based Stress Reduction	The Mindfulness-Based Stress Reduction program involves instruction in mindfulness meditation and yoga.

Timeline

• Start date: 2015-11-18
• Primary completion: 2019-06-20
• Completion: 2019-06-20
• First posted: 2015-08-07
• Last updated: 2019-11-15

Locations

1 site across 1 country: United States