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Completed

NCT Number: NCT03683147

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

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.

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Key information

Conditions

Stage IV Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

laboratory biomarker analysis

Other

Correlative studies

Meditation-Based Stress Reduction Program

Behavioral

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

Quality-of-Life Assessment

Other

Ancillary studies

Other names: Quality of Life Assessment

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Roswell Park Cancer Institute

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Sep 25, 2018
Registry last updated
Aug 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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