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

Stage IV Breast Cancer Clinical Trial

Official title:

RCT of Online Mindfulness-Based Stress Reduction for Metastatic Breast Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03683147
• Other study ID #: I 50317
• Secondary ID: NCI-2018-00453I
• Status: Completed
• Phase: N/A
• Start date: December 13, 2017
• Est. completion date: April 6, 2020

Study information

• Verified date: July 2022
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: April 6, 2020
• Est. primary completion date: June 19, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Stage IV Breast Cancer

Intervention

Other:
• Laboratory Biomarker Analysis
Correlative studies

Behavioral:
• Meditation-Based Stress Reduction Program
Participate in 6-week online program

Other:
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Improvement in depression as measured by the Brief Symptom Inventory (BSI-18)	BSI-18 - a self reported screening inventory to detect states of depression, anxiety and emotional distress.	Baseline and 6 weeks
Secondary	Improvement in anxiety as measured by BSI-18	Self reported screening inventory designed to assess participants level of anxiety.	Baseline and 6 weeks
Secondary	Improvement in fatigue measured with the Functional Assessment of Cancer Therapy Fatigue questionnaire	Measured using the Functional Assessment of Cancer Therapy Fatigue (FACT-Fatigue). A questionnaire assessing fatigue.	Baseline and 6 weeks
Secondary	Improvement in sleep impairment as measured by General Sleep Disturbance Scale	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	Baseline and 6 weeks
Secondary	Improvement in pain	Visual analog scales will be used to assess multiple pain dimensions per the National Comprehensive Cancer Network (NCCN) guidelines for adult cancer pain.	Baseline and 6 weeks
Secondary	Improvement in quality of life (QOL): FACT-B	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.	Baseline 6 weeks
Secondary	Improvement in blood pressure	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.	Baseline and 6 weeks
Secondary	Improvement in cancer-related biomarkers	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	Baseline and 6 weeks
Secondary	Increases in mindfulness	This will be measured with the Five Facet Mindfulness Questionnaire - (FFMQ). A questionnaire to explore mindfulness.	Baseline and 6 weeks