Mindfulness Meditation or Survivorship Education in Improving Behavioral Symptoms in Younger Stage 0-III Breast Cancer Survivors (Pathways to Wellness) (PTW)

July 18, 2022 updated by: Jonsson Comprehensive Cancer Center

Improving Outcomes for Younger Breast Cancer Survivors: A Phase III Randomized Trial Targeting Behavioral Symptoms in Younger Breast Cancer Survivors

This randomized phase III trial studies how well mindfulness meditation or survivorship education work in improving behavioral symptoms in younger stage 0-III breast cancer survivors. Behavioral interventions, such as mindfulness meditation, use techniques to help patients change the way they react to environmental triggers that may cause a negative reaction. Survivorship education after treatment may reduce stress and improve the well-being and quality of life of patients with breast cancer. Mindfulness meditation or survivorship education may help improve the health behaviors of younger breast cancer survivors.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. To evaluate the efficacy of two different types of group interventions (mindfulness and survivorship education), specifically tailored to the needs of younger female breast cancer survivors, in reducing depressive symptoms, compared to a usual care control group.

SECONDARY OBJECTIVES:

I. To compare the efficacy of the two interventions relative to a usual care control group on fatigue, sleep disturbance, and vasomotor symptoms.

II. To examine the efficacy of the two interventions relative to a usual care control group on circulating and genomic markers of inflammation.

III. To explore potential moderators and mediators of intervention efficacy in the two intervention groups.

OUTLINE: Patients are randomized to 1 of 3 arms.

ARM A (MINDFULNESS AWARENESS PRACTICES [MAPs]): Patients attend a mindfulness meditation class over 2 hours once weekly for 6 weeks. Patients then attend in person booster sessions that include guided meditation, questions, and discussion of how to maintain a mindfulness practice over 1 hour once monthly for 3 months.

ARM B (SURVIVORSHIP EDUCATION INTERVENTION [SE]): Patients attend a survivorship education class over 2 hours once weekly for 6 weeks. Patients also receive monthly electronic newsletters with tailored information about topics of interest to younger survivors, including cancer-related events in the community and tips about following through on recommendations for healthy living.

ARM C (USUAL CARE/DELAYED TREATMENT CONTROL GROUP): Patients receive usual care for 9 months. Patients are then offered a choice of participating in Arm A or Arm B.

After completion of study, patients are followed up at 3 and 6 months.

Study Type

Interventional

Enrollment (Actual)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • UCLA / Jonsson Comprehensive Cancer Center
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins University/Sidney Kimmel Cancer Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana-Farber Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 49 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women diagnosed with early stage, resectable breast cancer (Stage 0, I, II, or III) prior to age 50, and are within 5 years of diagnosis
  • Have completed all surgery, radiation, and/or chemotherapy treatments at least 6 months previously; may still be receiving trastuzumab or endocrine adjuvant therapy
  • Ability to complete evaluation surveys in English
  • Have evidence of at least mild clinical depression on a standardized screening questionnaire

Exclusion Criteria:

  • Has a breast cancer recurrence, metastasis, or another interval cancer diagnosis following the breast cancer (excluding non-melanoma skin cancer)
  • Unable to commit to intervention schedule (6 weekly group meetings)
  • Actively practicing mindfulness meditation
  • Has another serious or chronic medical or psychiatric condition that contributes to substantial physical or emotional disability that would detract from participating in either of the intervention programs or from the measurement of intervention outcomes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm A (MAPs)
Patients attend a mindfulness meditation class over 2 hours once weekly for 6 weeks. Patients then attend in person booster sessions that include guided meditation, questions, and discussion of how to maintain a mindfulness practice over 1 hour once monthly for 2 months.
Other: Laboratory Biomarker Analysis
Correlative studies
Other: Questionnaire Administration
Ancillary studies
Procedure: Meditation Therapy
Attend mindfulness meditation
Other Names:
  • Meditation
Active Comparator: Arm B (SE)
Patients attend a survivorship education class over 2 hours once weekly for 6 weeks. Patients also receive monthly electronic newsletters with tailored information about topics of interest to younger survivors, including cancer-related events in the community and tips about following through on recommendations for healthy living.
Other: Laboratory Biomarker Analysis
Correlative studies
Other: Questionnaire Administration
Ancillary studies
Other: Educational Intervention
Attend survivorship education
Other Names:
  • Education for Intervention
  • Intervention by Education
  • Intervention through Education
  • Intervention, Educational
Active Comparator: Arm C (USUAL CARE/DELAYED TREATMENT CONTROL GROUP)
Patients receive usual care for 9 months. Patients are then offered a choice of participating in Arm A or Arm B.
Other: Laboratory Biomarker Analysis
Correlative studies
Other: Questionnaire Administration
Ancillary studies
Procedure: Meditation Therapy
Attend mindfulness meditation
Other Names:
  • Meditation
Other: Educational Intervention
Attend survivorship education
Other Names:
  • Education for Intervention
  • Intervention by Education
  • Intervention through Education
  • Intervention, Educational

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in depressive symptoms measured by Center for Epidemiologic Studies Depression Scale score
Time Frame: 2 weeks post-intervention to 6 months
The data will be analyzed using linear mixed effects models, with fixed effects for time and condition and random effects for individuals. Differences between conditions in change over time will be examined by testing condition-by-time interaction terms. All tests will be two-sided. The Hochberg procedure will be applied to the two p-values for each intervention to control the familywise error rate at 0.05.
2 weeks post-intervention to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in fatigue assessed by Fatigue Symptom Inventory
Time Frame: 2 weeks post-intervention to 6 months
Will be tested using the mixed modeling approach, and p-values reported both with and without multiplicity adjustment. All tests will be two-sided.
2 weeks post-intervention to 6 months
Change in hot flashes measured by the vasomotor symptom severity subscale of the BCPT symptom scales questionnaire.
Time Frame: 2 weeks post-intervention to 6 months
Will be tested using the mixed modeling approach, and p-values reported both with and without multiplicity adjustment. All tests will be two-sided.
2 weeks post-intervention to 6 months
Change in inflammatory biomarkers will focus on laboratory measurements of Interleukin-6 (IL-6) and high sensitivity C-Reactive Protein (hsCRP)
Time Frame: 2 weeks post-intervention to 6 months
Will be tested using the mixed modeling approach, and p-values reported both with and without multiplicity adjustment. All tests will be two-sided.
2 weeks post-intervention to 6 months
Change in sleep disturbance assessed by Insomnia Severity Index
Time Frame: 2 weeks post-intervention to 6 months
Will be tested using the mixed modeling approach, and p-values reported both with and without multiplicity adjustment. All tests will be two-sided.
2 weeks post-intervention to 6 months
Mediators of intervention efficacy assessed by questionnaire
Time Frame: Up to 6 months
Mediators assessed will include self-efficacy, mindfulness, self-kindness, and rumination.
Up to 6 months
Moderators of intervention efficacy assessed by questionnaire
Time Frame: Up to 6 months
Moderators will include preparedness for survivorship, intervention preference, and childhood adversity. Will be assessed using condition-by-moderator interaction terms in mixed models.
Up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jonsson Comprehensive Cancer Center

Collaborators

National Cancer Institute (NCI)
National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Patricia Ganz, UCLA / Jonsson Comprehensive Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2017

Primary Completion (Anticipated)

February 1, 2023

Study Completion (Anticipated)

February 1, 2024

Study Registration Dates

First Submitted

January 17, 2017

First Submitted That Met QC Criteria

January 17, 2017

First Posted (Estimate)

January 19, 2017

Study Record Updates

Last Update Posted (Actual)

July 21, 2022

Last Update Submitted That Met QC Criteria

July 18, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-000817
  • NCI-2016-01396 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • R01CA200977 (U.S. NIH Grant/Contract)

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stage 0 Breast Cancer

Clinical Trials on Laboratory Biomarker Analysis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uruguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe