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

• ClinicalTrials.gov Identifier: NCT03025139
• Recruitment Status: Active, not recruiting
• First Posted: January 19, 2017
• Last Update Posted: July 21, 2022
• Sponsor: Jonsson Comprehensive Cancer Center
• Collaborators: National Cancer Institute (NCI); National Institutes of Health (NIH)
• Information provided by (Responsible Party): Jonsson Comprehensive Cancer Center

Tracking Information

• First Submitted Date: January 17, 2017
• First Posted Date: January 19, 2017
• Last Update Posted Date: July 21, 2022
• Actual Study Start Date: February 20, 2017
• Estimated Primary Completion Date: February 1, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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 (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: Mindfulness Meditation or Survivorship Education in Improving Behavioral Symptoms in Younger Stage 0-III Breast Cancer Survivors (Pathways to Wellness)
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care

Condition

• 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

• 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

• 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 *

• Bower JE, Partridge AH, Wolff AC, Cole SW, Irwin MR, Thorner ED, Joffe H, Petersen L, Crespi CM, Ganz PA. Improving biobehavioral health in younger breast cancer survivors: Pathways to Wellness trial secondary outcomes. J Natl Cancer Inst. 2023 Jan 10;115(1):83-92. doi: 10.1093/jnci/djac180.
• Bower JE, Partridge AH, Wolff AC, Thorner ED, Irwin MR, Joffe H, Petersen L, Crespi CM, Ganz PA. Targeting Depressive Symptoms in Younger Breast Cancer Survivors: The Pathways to Wellness Randomized Controlled Trial of Mindfulness Meditation and Survivorship Education. J Clin Oncol. 2021 Nov 1;39(31):3473-3484. doi: 10.1200/JCO.21.00279. Epub 2021 Aug 18.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: April 1, 2021): 96
• Original Estimated Enrollment (submitted: January 17, 2017): 360
• Estimated Study Completion Date: February 1, 2024
• Estimated Primary Completion Date: February 1, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: Female

• Ages: up to 49 Years (Child, Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03025139
• Other Study ID Numbers: 16-000817; NCI-2016-01396 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ); 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: Not Provided
• Current Responsible Party: Jonsson Comprehensive Cancer Center
• Original Responsible Party: Same as current
• Current Study Sponsor: Jonsson Comprehensive Cancer Center
• Original Study Sponsor: Same as current

Collaborators

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

Investigators

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

• PRS Account: Jonsson Comprehensive Cancer Center
• Verification Date: July 2022