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

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ClinicalTrials.gov Identifier: NCT03025139
Recruitment Status : Recruiting
First Posted : January 19, 2017
Last Update Posted : May 30, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

Tracking Information
First Submitted Date  ICMJE January 17, 2017
First Posted Date  ICMJE January 19, 2017
Last Update Posted Date May 30, 2019
Actual Study Start Date  ICMJE February 20, 2017
Estimated Primary Completion Date March 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 17, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 24, 2017)
  • 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.
  • 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.
  • 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.
  • 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.
  • Mediators of intervention efficacy assessed by questionnaire [ Time Frame: Up to 6 months ]
    Mediators assessed will include self-efficacy, mindfulness, self-kindness, and rumination.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 17, 2017)
  • 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.
  • Change in hot flashes [ 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.
  • Change in inflammatory biomarkers [ 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.
  • 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.
  • Mediators of intervention efficacy assessed by questionnaire [ Time Frame: Up to 6 months ]
    Mediators assessed will include self-efficacy, mindfulness, self-kindness, and rumination.
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mindfulness Meditation or Survivorship Education in Improving Behavioral Symptoms in Younger Stage 0-III Breast Cancer Survivors (Pathways to Wellness)
Official Title  ICMJE Improving Outcomes for Younger Breast Cancer Survivors: A Phase III Randomized Trial Targeting Behavioral Symptoms in Younger Breast Cancer Survivors
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Cancer Survivor
  • Early-Stage Breast Carcinoma
  • Stage 0 Breast Cancer
  • Stage IA Breast Cancer
  • Stage IB Breast Cancer
  • Stage IIA Breast Cancer
  • Stage IIB Breast Cancer
  • Stage IIIA Breast Cancer
  • Stage IIIB Breast Cancer
  • Stage IIIC Breast Cancer
Intervention  ICMJE
  • Other: Educational Intervention
    Attend survivorship education
    Other Names:
    • Education for Intervention
    • Intervention by Education
    • Intervention through Education
    • Intervention, Educational
  • Other: Laboratory Biomarker Analysis
    Correlative studies
  • Procedure: Meditation Therapy
    Attend mindfulness meditation
    Other Name: Meditation
  • Other: Questionnaire Administration
    Ancillary studies
Study Arms  ICMJE
  • 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.
    Interventions:
    • Other: Laboratory Biomarker Analysis
    • Procedure: Meditation Therapy
    • Other: Questionnaire Administration
  • 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.
    Interventions:
    • Other: Educational Intervention
    • Other: Laboratory Biomarker Analysis
    • Other: Questionnaire Administration
  • 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.
    Interventions:
    • Other: Educational Intervention
    • Other: Laboratory Biomarker Analysis
    • Procedure: Meditation Therapy
    • Other: Questionnaire Administration
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 28, 2019)
210
Original Estimated Enrollment  ICMJE
 (submitted: January 17, 2017)
360
Estimated Study Completion Date  ICMJE March 1, 2021
Estimated Primary Completion Date March 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE up to 49 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03025139
Other Study ID Numbers  ICMJE 16-000817
NCI-2016-01396 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
16-000817 ( Other Identifier: UCLA / Jonsson Comprehensive Cancer Center )
P30CA016042 ( U.S. NIH Grant/Contract )
R01CA200977 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jonsson Comprehensive Cancer Center
Study Sponsor  ICMJE Jonsson Comprehensive Cancer Center
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Patricia Ganz UCLA / Jonsson Comprehensive Cancer Center
PRS Account Jonsson Comprehensive Cancer Center
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP