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Stage IV Breast CancerNCT03683147

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

A study testing Laboratory Biomarker Analysis, Meditation-Based Stress Reduction Program and Quality-of-Life Assessment in people with Stage IV Breast Cancer, run by Roswell Park Cancer Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Stage IV Breast Cancer
What is being tested?
Laboratory Biomarker Analysis, Meditation-Based Stress Reduction Program and Quality-of-Life Assessment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteUnited States
Study dates
13 Dec 2017to 6 Apr 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

Other trials in United States

About this study

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

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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.

Being tested
Laboratory Biomarker Analysis, Meditation-Based Stress Reduction Program, Quality-of-Life Assessment, Questionnaire Administration
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • Meditation-Based Stress Reduction ProgramBehavioural

    Also called MBSR, MBSR(BC), Meditation-Based Stress Reduction, Meditation-Based Stress Reduction (Breast Cancer)

    Participate in 6-week online program

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

  • Questionnaire AdministrationOther

    Ancillary studies

Study groups in NCT03683147
Study groupRoleWhat they receive
Control (online sessions, content manual, CD after 6 weeks)ExperimentalParticipants randomized to the wait-list control condition complete the online intervention as in the intervention arm after the initial 6-week period has ended.
Receives: 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)ExperimentalParticipants 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.
Receives: Other: Laboratory Biomarker Analysis; Behavioral: Meditation-Based Stress Reduction Program; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: At 6 weeks

Secondary outcomes (9)

  1. 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.

    Measured: Baseline and 6 weeks

  2. Improvement in anxiety as measured by BSI-18

    Self reported screening inventory designed to assess participants level of anxiety.

    Measured: Baseline and 6 weeks

  3. 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.

    Measured: Baseline and 6 weeks

  4. 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

    Measured: Baseline and 6 weeks

  5. 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.

    Measured: Baseline and 6 weeks

  6. 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.

    Measured: Baseline 6 weeks

  7. 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.

    Measured: Baseline and 6 weeks

  8. 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

    Measured: Baseline and 6 weeks

  9. Increases in mindfulness

    This will be measured with the Five Facet Mindfulness Questionnaire - (FFMQ). A questionnaire to explore mindfulness.

    Measured: Baseline and 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2018
  2. Study start13 Dec 2017
  3. Primary completion19 Jun 2019
  4. Study completion6 Apr 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03683147
Sponsor's protocol ID
I 50317
Other IDs
NCI-2018-00453, I 50317
Status last verified
Aug 2024
First submitted
19 Sep 2018
Last updated
30 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Laboratory Biomarker Analysis, Meditation-Based Stress Reduction Program and Quality-of-Life Assessment in people with Stage IV Breast Cancer, run by Roswell Park Cancer Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of the online intervention for metastatic breast cancer patients (time frame: At 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03683147.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2024.

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