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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-0549 | Other Identifier | Institutional Review Board | |
| A532820 | Other Identifier | UW Madison | |
| SMPH\OBSTET & GYNECOL\OB-GYN | Other Identifier | UW Madison | |
| NCI-2015-01263 | Registry Identifier | NCI Trial ID |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (MBSR intervention) | Experimental | 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. |
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| Arm II (control) | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness-Based Stress Reduction | Behavioral | The Mindfulness-Based Stress Reduction program involves instruction in mindfulness meditation and yoga. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in anxiety | Measured by the 8-item anxiety subscale of the PROMIS scale. | Baseline to up to 5 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in depression | Measured by PROMIS subscale for depression. | Baseline to up to 5 months |
| Change in fatigue | Measured by PROMIS subscale for fatigue. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ryan Spencer | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin Carbone Cancer Center | Madison | Wisconsin | 53705 | United States |
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| Label | URL |
|---|---|
| University of Wisconsin Carbone Cancer Center Home Page | View source |
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|
| Baseline to up to 5 months |
| Change in sleep disturbance | Measured by PROMIS subscale for sleep disturbance. | Baseline to up to 5 months |
| Change in sexual function | Measured by Female Sexual Function Profile and Global Satisfaction with Sex Life questionnaire. | Baseline to up to 5 months |
| Change in existential/spiritual distress | measured by Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being Scale (FACIT-SP-12 version 4) | Baseline to up to 5 months |
| Change in cognitive function | Measured by the NIH Toolbox Assessments | Baseline to up to 5 months |
| Change in cortisol levels | The biobehavioral link between MBSR intervention-related Quality of Life changes and immune cell function will be explored. | Baseline to up to 5 months |
| Change in levels of pro-inflammatory cytokines | The biobehavioral link between MBSR intervention-related Quality of Life changes and immune cell function will be explored. | Baseline to up to 5 months |
| Change in immune cell phenotypes | The biobehavioral link between MBSR intervention-related Quality of Life changes and immune cell function will be explored. | Baseline to up to 5 months |
| Change in NK cell function | The biobehavioral link between MBSR intervention-related Quality of Life changes and immune cell function will be explored. | Baseline to up to 5 months |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D060825 | Cognitive Dysfunction |
| D003863 | Depression |
| D005221 | Fatigue |
| D010146 | Pain |
| D012735 | Sexual Dysfunction, Physiological |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D000099024 | Mindfulness-Based Stress Reduction |
| ID | Term |
|---|---|
| D064866 | Mindfulness |
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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