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

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.

Study Overview

• Status: Completed
• Conditions: Depression; Pain; Fatigue; Cognitive Impairment; Anxiety; Sexual Dysfunction; Distress; Cancer Survivor; Malignant Female Reproductive System Neoplasm
• Intervention / Treatment: Behavioral: Mindfulness-Based Stress Reduction

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).

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53705
      • University of Wisconsin Carbone Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Investigators: Principal Investigator: Ryan Spencer, University of Wisconsin, Madison

Publications and helpful links

Helpful Links

• University of Wisconsin Carbone Cancer Center Home Page

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2015
• Primary Completion (Actual): June 20, 2019
• Study Completion (Actual): June 20, 2019

Study Registration Dates

• First Submitted: August 4, 2015
• First Submitted That Met QC Criteria: August 4, 2015
• First Posted (Estimate): August 7, 2015

Study Record Updates

• Last Update Posted (Actual): November 15, 2019
• Last Update Submitted That Met QC Criteria: November 13, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Female
• Other Study ID Numbers: UW15000; A532820 (Other Identifier: UW Madison); 2015-0549 (Other Identifier: Institutional Review Board); SMPH\OBSTET & GYNECOL\OB-GYN (Other Identifier: UW Madison); NCI-2015-01263 (Registry Identifier: NCI Trial ID)