PTW: Mindfulness Meditation or Survivorship Education in Improving Behavioral Symptoms in Younger Stage 0-III Breast Cancer Survivors (Pathways to Wellness)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
PRIMARY OBJECTIVES:
- 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:
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To compare the efficacy of the two interventions relative to a usual care control group on fatigue, sleep disturbance, and vasomotor symptoms.
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To examine the efficacy of the two interventions relative to a usual care control group on circulating and genomic markers of inflammation.
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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 Design
Arms and Interventions
| 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
Procedure: Meditation Therapy
Attend mindfulness meditation
Other Names:
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:
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:
Other: Laboratory Biomarker Analysis
Correlative studies
Procedure: Meditation Therapy
Attend mindfulness meditation
Other Names:
Other: Questionnaire Administration
Ancillary studies
|
Outcome Measures
Primary Outcome Measures
- Change in depressive symptoms measured by Center for Epidemiologic Studies Depression Scale score [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 [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. [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) [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 [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 [Up to 6 months]
Mediators assessed will include self-efficacy, mindfulness, self-kindness, and rumination.
- Moderators of intervention efficacy assessed by questionnaire [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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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
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Have completed all surgery, radiation, and/or chemotherapy treatments at least 6 months previously; may still be receiving trastuzumab or endocrine adjuvant therapy
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Ability to complete evaluation surveys in English
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Have evidence of at least mild clinical depression on a standardized screening questionnaire
Exclusion Criteria:
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Has a breast cancer recurrence, metastasis, or another interval cancer diagnosis following the breast cancer (excluding non-melanoma skin cancer)
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Unable to commit to intervention schedule (6 weekly group meetings)
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Actively practicing mindfulness meditation
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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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UCLA / Jonsson Comprehensive Cancer Center | Los Angeles | California | United States | 90095 |
| 2 | Johns Hopkins University/Sidney Kimmel Cancer Center | Baltimore | Maryland | United States | 21287 |
| 3 | Dana-Farber Cancer Institute | Boston | Massachusetts | United States | 02115 |
Sponsors and Collaborators
- Jonsson Comprehensive Cancer Center
- National Cancer Institute (NCI)
- National Institutes of Health (NIH)
Investigators
- Principal Investigator: Patricia Ganz, UCLA / Jonsson Comprehensive Cancer Center
Study Documents (Full-Text)
More Information
Publications
None provided.- 16-000817
- NCI-2016-01396
- R01CA200977