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

Primary Purpose

Stage IV Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Laboratory Biomarker Analysis
Meditation-Based Stress Reduction Program
Quality-of-Life Assessment
Questionnaire Administration
Sponsored by
Roswell Park Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stage IV Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Roswell Park Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

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

Intervention (online sessions, content manual, relaxation CD)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Improvement in anxiety as measured by BSI-18
Self reported screening inventory designed to assess participants level of anxiety.
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.
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
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.
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.
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.
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
Increases in mindfulness
This will be measured with the Five Facet Mindfulness Questionnaire - (FFMQ). A questionnaire to explore mindfulness.

Full Information

First Posted
September 19, 2018
Last Updated
July 20, 2022
Sponsor
Roswell Park Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03683147
Brief Title
Mindfulness-Based Stress Reduction in Helping Participants With Metastatic Breast Cancer
Official Title
RCT of Online Mindfulness-Based Stress Reduction for Metastatic Breast Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
December 13, 2017 (Actual)
Primary Completion Date
June 19, 2019 (Actual)
Study Completion Date
April 6, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Roswell Park Cancer Institute

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage IV Breast Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control (online sessions, content manual, CD after 6 weeks)
Arm Type
Experimental
Arm Description
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.
Arm Title
Intervention (online sessions, content manual, relaxation CD)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Laboratory Biomarker Analysis
Intervention Description
Correlative studies
Intervention Type
Behavioral
Intervention Name(s)
Meditation-Based Stress Reduction Program
Other Intervention Name(s)
MBSR, MBSR(BC), Meditation-Based Stress Reduction, Meditation-Based Stress Reduction (Breast Cancer), Meditation-Based Stress Reduction for Breast Cancer
Intervention Description
Participate in 6-week online program
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Feasibility of the online intervention for metastatic breast cancer patients
Description
Successfully completing 4 out of 6 week sessions of online intervention for distressed metastatic breast cancer patients.
Time Frame
At 6 weeks
Secondary Outcome Measure Information:
Title
Improvement in depression as measured by the Brief Symptom Inventory (BSI-18)
Description
BSI-18 - a self reported screening inventory to detect states of depression, anxiety and emotional distress.
Time Frame
Baseline and 6 weeks
Title
Improvement in anxiety as measured by BSI-18
Description
Self reported screening inventory designed to assess participants level of anxiety.
Time Frame
Baseline and 6 weeks
Title
Improvement in fatigue measured with the Functional Assessment of Cancer Therapy Fatigue questionnaire
Description
Measured using the Functional Assessment of Cancer Therapy Fatigue (FACT-Fatigue). A questionnaire assessing fatigue.
Time Frame
Baseline and 6 weeks
Title
Improvement in sleep impairment as measured by General Sleep Disturbance Scale
Description
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
Time Frame
Baseline and 6 weeks
Title
Improvement in pain
Description
Visual analog scales will be used to assess multiple pain dimensions per the National Comprehensive Cancer Network (NCCN) guidelines for adult cancer pain.
Time Frame
Baseline and 6 weeks
Title
Improvement in quality of life (QOL): FACT-B
Description
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.
Time Frame
Baseline 6 weeks
Title
Improvement in blood pressure
Description
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.
Time Frame
Baseline and 6 weeks
Title
Improvement in cancer-related biomarkers
Description
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
Time Frame
Baseline and 6 weeks
Title
Increases in mindfulness
Description
This will be measured with the Five Facet Mindfulness Questionnaire - (FFMQ). A questionnaire to explore mindfulness.
Time Frame
Baseline and 6 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Hydeman
Organizational Affiliation
Roswell Park Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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