Mindfulness-Based Stress Reduction in Helping Participants With Metastatic Breast Cancer

NCT ID: NCT03683147

Last Updated: 2024-08-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-13
• Study Completion Date: 2020-04-06

Brief Summary

This randomized trial studies how well a mindfulness-based stress reduction program helps participants with breast cancer that has spread to other places in the body. A cancer diagnosis is a life-changing and highly stressful event for most people, often resulting in marked declines in quality of life both during and after treatment. There are approximately 3 million women living with a history of invasive breast cancer in the U.S., with at least 150,000 living with metastatic disease. Patient preferences suggest a high need for complementary and alternative medicine interventions to address these chronic symptoms. Mindfulness-based stress reduction programs may help women living with metastatic breast cancer manage symptoms related to cancer treatment and improve quality of life.

Detailed Description

PRIMARY OBJECTIVES:

I. To develop a novel online mindfulness-based stress reduction (MBSR) treatment for distressed metastatic breast cancer patients in the hope of reaching patients otherwise unable to participate in traditional interventions due to high symptom burden.

II. Determine the impact of the intervention on both patient self-report and biological symptom measures.

OUTLINE: Participants are randomized to 1 of 2 arms.

INTERVENTION ARM: Participants receive online group sessions over 60 minutes for 6 weeks, including 15 minutes of practice on that session's topic and daily meditation or yoga for 45 minutes. At the conclusion of the study period participants participate in mindfulness meditation over 3 hours. Participants also receive a content manual and relaxation compact disc (CD).

CONTROL ARM: Participants randomized to the wait-list control condition complete the online intervention as in the intervention arm after the initial 6-week period has ended.

Conditions

Stage IV Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Control (online sessions, content manual, CD after 6 weeks)

Participants randomized to the wait-list control condition complete the online intervention as in the intervention arm after the initial 6-week period has ended.

Group Type: EXPERIMENTAL

Laboratory Biomarker Analysis

Intervention Type: OTHER

Correlative studies

Meditation-Based Stress Reduction Program

Intervention Type: BEHAVIORAL

Participate in 6-week online program

Quality-of-Life Assessment

Intervention Type: OTHER

Ancillary studies

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Intervention (online sessions, content manual, relaxation CD)

Participants receive online group sessions over 60 minutes for 6 weeks, including 15 minutes of practice on that session's topic and daily meditation or yoga for 45 minutes. At the conclusion of the study period participants participate in mindfulness meditation over 3 hours. Participants also receive a content manual and relaxation CD.

Group Type: EXPERIMENTAL

Laboratory Biomarker Analysis

Intervention Type: OTHER

Correlative studies

Meditation-Based Stress Reduction Program

Intervention Type: BEHAVIORAL

Participate in 6-week online program

Quality-of-Life Assessment

Intervention Type: OTHER

Ancillary studies

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Interventions

Laboratory Biomarker Analysis

Correlative studies

Intervention Type: OTHER

Meditation-Based Stress Reduction Program

Participate in 6-week online program

Intervention Type: BEHAVIORAL

Quality-of-Life Assessment

Ancillary studies

Intervention Type: OTHER

Questionnaire Administration

Ancillary studies

Intervention Type: OTHER

Other Intervention Names

MBSR; MBSR(BC); Meditation-Based Stress Reduction; Meditation-Based Stress Reduction (Breast Cancer); Meditation-Based Stress Reduction for Breast Cancer; Quality of Life Assessment

Eligibility Criteria

Inclusion Criteria

• A diagnosis of metastatic breast cancer within the past 5 years and treated at Roswell Park Cancer Institute (RPCI)
• Ability to read and understand English
• Current distress score of 4+ on the National Comprehensive Cancer Network (NCCN) distress thermometer
• Access to an Internet connection with own device (computer, tablet, smartphone, etc.)
• Patient not currently involved in an ongoing psychological intervention
• If taking prescribed medication for mood or anxiety disorder, dosage has been consistent for prior 3 months

Exclusion Criteria

• Unable to speak and understand English
• Prior or current experience with mindfulness-based practice
• Diagnosis of a psychotic disorder, bipolar disorder, substance abuse disorder, or reported suicidality
• Current involvement in any other psychological treatment (excluding medication) during study duration
• Currently being treated for another cancer diagnosis other than metastatic breast cancer

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

Sponsors

Roswell Park Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chi-Chen Hong, PhD

Role: PRINCIPAL_INVESTIGATOR

Roswell Park Cancer Institute

Locations

Roswell Park Cancer Institute

Buffalo, New York, United States

Countries

United States

Other Identifiers

NCI-2018-00453

Identifier Type: REGISTRY

Identifier Source: secondary_id

I 50317

Identifier Type: OTHER

Identifier Source: secondary_id

I 50317

Identifier Type: -

Identifier Source: org_study_id