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

NCT03683147 | Completed

• 2 other identifiers: I 50317NCI-2018-00453
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Stage IV Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Feasibility of the online intervention for metastatic breast cancer patients

  Successfully completing 4 out of 6 week sessions of online intervention for distressed metastatic breast cancer patients.

  At 6 weeks

Secondary Outcomes (9)

• Improvement in depression as measured by the Brief Symptom Inventory (BSI-18)

  Baseline and 6 weeks

• Improvement in anxiety as measured by BSI-18

  Baseline and 6 weeks

• Improvement in fatigue measured with the Functional Assessment of Cancer Therapy Fatigue questionnaire

  Baseline and 6 weeks

• Improvement in sleep impairment as measured by General Sleep Disturbance Scale

  Baseline and 6 weeks

• Improvement in pain

  Baseline and 6 weeks

Study Arms (2)

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

EXPERIMENTAL

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.

Other: Laboratory Biomarker Analysis; Behavioral: Meditation-Based Stress Reduction Program; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Intervention (online sessions, content manual, relaxation CD)

EXPERIMENTAL

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.

Other: Laboratory Biomarker Analysis; Behavioral: Meditation-Based Stress Reduction Program; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Laboratory Biomarker Analysis OTHER

Correlative studies

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

Meditation-Based Stress Reduction Program BEHAVIORAL

Participate in 6-week online program

Also known as: MBSR, MBSR(BC), Meditation-Based Stress Reduction, Meditation-Based Stress Reduction (Breast Cancer), Meditation-Based Stress Reduction for Breast Cancer

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

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

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

Questionnaire Administration OTHER

Ancillary studies

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

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Chi-Chen Hong, PhD

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2018
• First Posted: September 25, 2018
• Study Start: December 13, 2017
• Primary Completion: June 19, 2019
• Study Completion: April 6, 2020
• Last Updated: August 30, 2024

Record last verified: 2024-08

Locations

US (1)