We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study is currently recruiting participants.
Verified January 2017 by Jonsson Comprehensive Cancer Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT03025139
First Posted: January 19, 2017
Last Update Posted: March 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center
  Purpose
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.

Condition Intervention
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 Other: Educational Intervention Other: Laboratory Biomarker Analysis Procedure: Meditation Therapy Other: Questionnaire Administration

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Improving Outcomes for Younger Breast Cancer Survivors: A Phase III Randomized Trial Targeting Behavioral Symptoms in Younger Breast Cancer Survivors

Resource links provided by NLM:


Further study details as provided by Jonsson Comprehensive Cancer Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 360
Actual Study Start Date: February 20, 2017
Estimated Study Completion Date: March 1, 2020
Estimated Primary Completion Date: March 1, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Procedure: Meditation Therapy
Attend mindfulness meditation
Other Name: Meditation
Other: Questionnaire Administration
Ancillary studies
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: Educational Intervention
Attend survivorship education
Other Names:
  • Education for Intervention
  • Intervention by Education
  • Intervention through Education
  • Intervention, Educational
Other: Laboratory Biomarker Analysis
Correlative studies
Other: Questionnaire Administration
Ancillary studies
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: 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

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 49 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women diagnosed with early stage, resectable breast cancer (Stage 0, I, II, or III) prior to age 45, 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03025139


Locations
United States, California
UCLA / Jonsson Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90095
Contact: Patricia A. Ganz    310-206-1404    pganz@mednet.ucla.edu   
Principal Investigator: Patricia A. Ganz         
United States, Maryland
Johns Hopkins University/Sidney Kimmel Cancer Center Recruiting
Baltimore, Maryland, United States, 21287
Contact: Antonio C. Wolff    410-614-4192    awolff@jhmi.edu   
Principal Investigator: Antonio C. Wolff         
United States, Massachusetts
Dana-Farber Cancer Institute Not yet recruiting
Boston, Massachusetts, United States, 02115
Contact: Ann H. Partridge    617-632-6081    Ann_partridge@DFCI.Harvard.edu   
Principal Investigator: Ann H. Partridge         
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Patricia Ganz UCLA / Jonsson Comprehensive Cancer Center
  More Information

Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT03025139     History of Changes
Other Study ID Numbers: 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 )
First Submitted: January 17, 2017
First Posted: January 19, 2017
Last Update Posted: March 23, 2017
Last Verified: January 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jonsson Comprehensive Cancer Center:
breast cancer
younger women
education
mindfulness meditation
depression
cancer survivor

Additional relevant MeSH terms:
Breast Neoplasms
Behavioral Symptoms
Breast Carcinoma In Situ
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Carcinoma in Situ
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type