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

NCT ID: NCT02518308

Last Updated: 2019-11-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-18
• Study Completion Date: 2019-06-20

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).

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Mindfulness-Based Stress Reduction

Intervention Type: BEHAVIORAL

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

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Mindfulness-Based Stress Reduction

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

Intervention Type: BEHAVIORAL

Other Intervention Names

MBSR

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ryan Spencer

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, United States

Countries

United States

Related Links

http://www.uwhealth.org/uw-carbone-cancer-center/cancer/10252

University of Wisconsin Carbone Cancer Center Home Page

Other Identifiers

2015-0549

Identifier Type: OTHER

Identifier Source: secondary_id

A532820

Identifier Type: OTHER

Identifier Source: secondary_id

SMPH\OBSTET & GYNECOL\OB-GYN

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-2015-01263

Identifier Type: REGISTRY

Identifier Source: secondary_id

UW15000

Identifier Type: -

Identifier Source: org_study_id