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

• ClinicalTrials.gov Identifier: NCT03683147
• Recruitment Status: Completed
• First Posted: September 25, 2018
• Last Update Posted: April 10, 2020
• Sponsor: Roswell Park Cancer Institute
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): Roswell Park Cancer Institute

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Stage IV Breast Cancer	Other: Laboratory Biomarker Analysis; Behavioral: Meditation-Based Stress Reduction Program; Other: Quality-of-Life Assessment; Other: Questionnaire Administration	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 44 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: RCT of Online Mindfulness-Based Stress Reduction for Metastatic Breast Cancer Patients
• Actual Study Start Date: December 13, 2017
• Actual Primary Completion Date: June 19, 2019
• Actual Study Completion Date: April 6, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Other: Laboratory Biomarker Analysis; Correlative studies; Behavioral: Meditation-Based Stress Reduction Program; Participate in 6-week online program; Other Names: MBSR; MBSR(BC); Meditation-Based Stress Reduction; Meditation-Based Stress Reduction (Breast Cancer); Meditation-Based Stress Reduction for Breast Cancer; Other: Quality-of-Life Assessment; Ancillary studies; Other Name: Quality of Life Assessment; Other: Questionnaire Administration; Ancillary studies
Experimental: 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.	Other: Laboratory Biomarker Analysis; Correlative studies; Behavioral: Meditation-Based Stress Reduction Program; Participate in 6-week online program; Other Names: MBSR; MBSR(BC); Meditation-Based Stress Reduction; Meditation-Based Stress Reduction (Breast Cancer); Meditation-Based Stress Reduction for Breast Cancer; Other: Quality-of-Life Assessment; Ancillary studies; Other Name: Quality of Life Assessment; Other: Questionnaire Administration; Ancillary studies

Outcome Measures

Primary Outcome Measures :

1. Feasibility of the online intervention for metastatic breast cancer patients [ Time Frame: At 6 weeks ]
   Successfully completing 4 out of 6 week sessions of online intervention for distressed metastatic breast cancer patients.

Secondary Outcome Measures :

1. Improvement in depression as measured by the Brief Symptom Inventory (BSI-18) [ Time Frame: Baseline and 6 weeks ]
   BSI-18 - a self reported screening inventory to detect states of depression, anxiety and emotional distress.
2. Improvement in anxiety as measured by BSI-18 [ Time Frame: Baseline and 6 weeks ]
   Self reported screening inventory designed to assess participants level of anxiety.
3. Improvement in fatigue measured with the Functional Assessment of Cancer Therapy Fatigue questionnaire [ Time Frame: Baseline and 6 weeks ]
   Measured using the Functional Assessment of Cancer Therapy Fatigue (FACT-Fatigue). A questionnaire assessing fatigue.
4. Improvement in sleep impairment as measured by General Sleep Disturbance Scale [ Time Frame: Baseline and 6 weeks ]
   Measured using the General Sleep Disturbance Scale - A 21 item scale rating specific sleep problems from 0 (not at all) to 7 (every day) used to evaluate sleep disturbance
5. Improvement in pain [ Time Frame: Baseline and 6 weeks ]
   Visual analog scales will be used to assess multiple pain dimensions per the National Comprehensive Cancer Network (NCCN) guidelines for adult cancer pain.
6. Improvement in quality of life (QOL): FACT-B [ Time Frame: Baseline 6 weeks ]
   This will be measured with the Functional Assessment of Cancer Comparisons made between the baseline and post-intervention assessment (6-week) will utilize one-sided permutation paired t-tests; with bootstrap or non-parametric methods considered as appropriate.
7. Improvement in blood pressure [ Time Frame: Baseline and 6 weeks ]
   Blood pressure will be taken twice at each of the study time-points to ensure an accurate reading. All outcome measures are treated as quantitative variables and will be summarized by cohort and time-point using the appropriate descriptive statistics. Comparisons made between the baseline and post-intervention assessment (6-week) will utilize one-sided permutation paired t-tests; with bootstrap or non-parametric methods considered as appropriate.
8. Improvement in cancer-related biomarkers [ Time Frame: Baseline and 6 weeks ]
   A panel of 25 cytokines reflecting Th1, Th2, and Th17 immunity will be collected, including (GMCSF, IFN-v, IL-1f3, IL-2, IL-4, IL-5, IL-6, IL-9, IL-10, IL-12, IL-13, IL-15, IL-17A, IL-17F, IL-17E/IL-25, IL-21, IL-22, IL-23, IL-27, IL-28A, IL-31, IL-33, MIP-3a/CCL20, TNFa, TNF|3). To visualize the pattern of immunologic markers that jointly distinguish intervention arms, hypothesis
9. Increases in mindfulness [ Time Frame: Baseline and 6 weeks ]
   This will be measured with the Five Facet Mindfulness Questionnaire - (FFMQ). A questionnaire to explore mindfulness.

Eligibility Criteria

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

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

Contacts and Locations

Locations

United States, New York

Roswell Park Cancer Institute

Buffalo, New York, United States, 14263

Sponsors and Collaborators

Roswell Park Cancer Institute

National Cancer Institute (NCI)

Investigators

• Principal Investigator: Jennifer Hydeman; Roswell Park Cancer Institute

More Information

• Responsible Party: Roswell Park Cancer Institute
• ClinicalTrials.gov Identifier: NCT03683147
• Other Study ID Numbers: I 50317; NCI-2018-00453 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ); I 50317 ( Other Identifier: Roswell Park Cancer Institute ); P30CA016056 ( U.S. NIH Grant/Contract )
• First Posted: September 25, 2018
• Last Update Posted: April 10, 2020
• Last Verified: April 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases