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

Primary Purpose

Anxiety, Cancer Survivor, Cognitive Impairment

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness-Based Stress Reduction
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anxiety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Wisconsin Carbone Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Arm I (MBSR intervention)

Arm II (control)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in anxiety
Measured by the 8-item anxiety subscale of the PROMIS scale.

Secondary Outcome Measures

Change in depression
Measured by PROMIS subscale for depression.
Change in fatigue
Measured by PROMIS subscale for fatigue.
Change in sleep disturbance
Measured by PROMIS subscale for sleep disturbance.
Change in sexual function
Measured by Female Sexual Function Profile and Global Satisfaction with Sex Life questionnaire.
Change in existential/spiritual distress
measured by Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being Scale (FACIT-SP-12 version 4)
Change in cognitive function
Measured by the NIH Toolbox Assessments
Change in cortisol levels
The biobehavioral link between MBSR intervention-related Quality of Life changes and immune cell function will be explored.
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.
Change in immune cell phenotypes
The biobehavioral link between MBSR intervention-related Quality of Life changes and immune cell function will be explored.
Change in NK cell function
The biobehavioral link between MBSR intervention-related Quality of Life changes and immune cell function will be explored.

Full Information

First Posted
August 4, 2015
Last Updated
November 13, 2019
Sponsor
University of Wisconsin, Madison
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1. Study Identification

Unique Protocol Identification Number
NCT02518308
Brief Title
Mindfulness Intervention in Reducing Anxiety in Patients Who Have Been Treated for Gynecologic Cancer
Official Title
Mindfulness-Based Interventions in Patients Treated for Gynecologic Cancer - Impact on Patient Reported Outcomes and Immunologic Correlates
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
November 18, 2015 (Actual)
Primary Completion Date
June 20, 2019 (Actual)
Study Completion Date
June 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison

4. Oversight

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Cancer Survivor, Cognitive Impairment, Depression, Distress, Fatigue, Malignant Female Reproductive System Neoplasm, Pain, Sexual Dysfunction

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I (MBSR intervention)
Arm Type
Experimental
Arm Description
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 Title
Arm II (control)
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-Based Stress Reduction
Other Intervention Name(s)
MBSR
Intervention Description
The Mindfulness-Based Stress Reduction program involves instruction in mindfulness meditation and yoga.
Primary Outcome Measure Information:
Title
Change in anxiety
Description
Measured by the 8-item anxiety subscale of the PROMIS scale.
Time Frame
Baseline to up to 5 months
Secondary Outcome Measure Information:
Title
Change in depression
Description
Measured by PROMIS subscale for depression.
Time Frame
Baseline to up to 5 months
Title
Change in fatigue
Description
Measured by PROMIS subscale for fatigue.
Time Frame
Baseline to up to 5 months
Title
Change in sleep disturbance
Description
Measured by PROMIS subscale for sleep disturbance.
Time Frame
Baseline to up to 5 months
Title
Change in sexual function
Description
Measured by Female Sexual Function Profile and Global Satisfaction with Sex Life questionnaire.
Time Frame
Baseline to up to 5 months
Title
Change in existential/spiritual distress
Description
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
Title
Change in cognitive function
Description
Measured by the NIH Toolbox Assessments
Time Frame
Baseline to up to 5 months
Title
Change in cortisol levels
Description
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
Title
Change in levels of pro-inflammatory cytokines
Description
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
Title
Change in immune cell phenotypes
Description
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
Title
Change in NK cell function
Description
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ryan Spencer
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin Carbone Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.uwhealth.org/uw-carbone-cancer-center/cancer/10252
Description
University of Wisconsin Carbone Cancer Center Home Page

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

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