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

NCT02518308 | Completed

• 5 other identifiers: UW150002015-0549A532820SMPH\OBSTET & GYNECOL\OB-GYNNCI-2015-01263
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Change in anxiety

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

  Baseline to up to 5 months

Secondary Outcomes (10)

• Change in depression

  Baseline to up to 5 months

• Change in fatigue

  Baseline to up to 5 months

• Change in sleep disturbance

  Baseline to up to 5 months

• Change in sexual function

  Baseline to up to 5 months

• Change in existential/spiritual distress

  Baseline to up to 5 months

Study Arms (2)

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.

Behavioral: Mindfulness-Based Stress Reduction

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.

Interventions

Mindfulness-Based Stress Reduction BEHAVIORAL

The Mindfulness-Based Stress Reduction program involves instruction in mindfulness meditation and yoga.

Also known as: MBSR

Arm I (MBSR intervention)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, 53705, United States

Location

Related Links

• University of Wisconsin Carbone Cancer Center Home Page

MeSH Terms

Conditions

Anxiety Disorders; Cognitive Dysfunction; Depression; Fatigue; Pain; Sexual Dysfunction, Physiological

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Mental Disorders; Cognition Disorders; Neurocognitive Disorders; Behavioral Symptoms; Behavior; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Ryan Spencer

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2015
• First Posted: August 7, 2015
• Study Start: November 18, 2015
• Primary Completion: June 20, 2019
• Study Completion: June 20, 2019
• Last Updated: November 15, 2019

Record last verified: 2019-07

Locations

US (1)