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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

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

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

Intervention / Treatment
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* Behavioral: Mindfulness-Based Stress Reduction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of any invasive gynecologic cancer without evidence of disease. Gynecologic cancer treatment (e.g., surgery, chemotherapy, radiation therapy) was completed within 5 years prior to date of enrollment. Able to speak, read and write English ECOG Performance Status between 0 and 3 Subjects must have a phone. Experiencing 2 or more of the following symptoms felt to be associated (per the patient) with gynecologic cancer or previous gynecologic cancer treatment: anxiety (worry or feeling stressed), cognitive impairment (difficulty concentrating, focusing, memory loss), depression, existential/spiritual distress (hopelessness, lack of meaning in life, lack of peace), fatigue, pain, and sexual dysfunction. These symptoms may be new or worsened since cancer diagnosis. Both symptoms fomr this list must have been present one week prior to eligibility assessment, with worst severity rating greater than or equal to 3 (0-10 scale) for at least 1 of the 2 symptoms Expected to continue cancer care at UWCCC for the duration of the study. Exclusion Criteria: Undergone cancer treatment (excluding hormonal therapy or biological maintenance therapy) in the 4 weeks prior to enrollment Expected to require cancer treatment, other than biologic or hormonal maintenance therapy, during the course of the study Any other cancer present within the last 5 years (other than gynecologic cancer under study and non-melanoma skin cancer) Practicing mindfulness meditation for an average of more than 1 hour/week or have taken mindfulness training in the past Documented history of Alzheimer's disease, dementia, or other neurologic deficit that could impact decision-making Prisoner or incarcerated

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (MBSR intervention)<br>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. | Behavioral: Mindfulness-Based Stress Reduction<br>* The Mindfulness-Based Stress Reduction program involves instruction in mindfulness meditation and yoga.<br>* Other names: MBSR;|
| No Intervention: Arm II (control)<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in anxiety | Measured by the 8-item anxiety subscale of the PROMIS scale. | Baseline to up to 5 months | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 |