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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02518308
Recruitment Status : Completed
First Posted : August 7, 2015
Last Update Posted : November 15, 2019
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief 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.

Condition or disease Intervention/treatment Phase
Anxiety Cancer Survivor Cognitive Impairment Depression Distress Fatigue Malignant Female Reproductive System Neoplasm Pain Sexual Dysfunction Behavioral: Mindfulness-Based Stress Reduction Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Supportive Care
Official Title: Mindfulness-Based Interventions in Patients Treated for Gynecologic Cancer - Impact on Patient Reported Outcomes and Immunologic Correlates
Actual Study Start Date : November 18, 2015
Actual Primary Completion Date : June 20, 2019
Actual Study Completion Date : June 20, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Arm I (MBSR 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.
Behavioral: Mindfulness-Based Stress Reduction
The Mindfulness-Based Stress Reduction program involves instruction in mindfulness meditation and yoga.
Other Name: MBSR

No Intervention: Arm II (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.



Primary Outcome Measures :
  1. Change in anxiety [ Time Frame: Baseline to up to 5 months ]
    Measured by the 8-item anxiety subscale of the PROMIS scale.


Secondary Outcome Measures :
  1. Change in depression [ Time Frame: Baseline to up to 5 months ]
    Measured by PROMIS subscale for depression.

  2. Change in fatigue [ Time Frame: Baseline to up to 5 months ]
    Measured by PROMIS subscale for fatigue.

  3. Change in sleep disturbance [ Time Frame: Baseline to up to 5 months ]
    Measured by PROMIS subscale for sleep disturbance.

  4. Change in sexual function [ Time Frame: Baseline to up to 5 months ]
    Measured by Female Sexual Function Profile and Global Satisfaction with Sex Life questionnaire.

  5. Change in existential/spiritual distress [ 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)

  6. Change in cognitive function [ Time Frame: Baseline to up to 5 months ]
    Measured by the NIH Toolbox Assessments

  7. Change in cortisol levels [ 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.

  8. Change in levels of pro-inflammatory cytokines [ 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.

  9. Change in immune cell phenotypes [ 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.

  10. Change in NK cell function [ 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02518308


Locations
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United States, Wisconsin
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States, 53705
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
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Principal Investigator: Ryan Spencer University of Wisconsin, Madison
Additional Information:
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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT02518308    
Other Study ID Numbers: UW15000
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 )
First Posted: August 7, 2015    Key Record Dates
Last Update Posted: November 15, 2019
Last Verified: July 2019
Additional relevant MeSH terms:
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Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms