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 |
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Recruitment Status :
Active, not recruiting
First Posted : January 19, 2017
Last Update Posted : July 21, 2022
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Sponsor:
Jonsson Comprehensive Cancer Center
Collaborators:
National Cancer Institute (NCI)
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center
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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 |
|---|---|---|
| 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 | Not Applicable |
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 (Clinical Trial) |
| Actual Enrollment : | 96 participants |
| 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 |
| Actual Study Start Date : | February 20, 2017 |
| Estimated Primary Completion Date : | February 1, 2023 |
| Estimated Study Completion Date : | February 1, 2024 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Breast cancer
| Arm | Intervention/treatment |
|---|---|
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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.
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Other: Laboratory Biomarker Analysis
Correlative studies Procedure: Meditation Therapy Attend mindfulness meditation
Other Name: Meditation Other: Questionnaire Administration Ancillary studies |
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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.
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Other: Educational Intervention
Attend survivorship education
Other Names:
Other: Laboratory Biomarker Analysis Correlative studies Other: Questionnaire Administration Ancillary studies |
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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.
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Other: Educational Intervention
Attend survivorship education
Other Names:
Other: Laboratory Biomarker Analysis Correlative studies Procedure: Meditation Therapy Attend mindfulness meditation
Other Name: Meditation Other: Questionnaire Administration Ancillary studies |
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.
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| 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 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
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 | |
| Los Angeles, California, United States, 90095 | |
| United States, Maryland | |
| Johns Hopkins University/Sidney Kimmel Cancer Center | |
| Baltimore, Maryland, United States, 21287 | |
| United States, Massachusetts | |
| 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)
Documents provided by Jonsson Comprehensive Cancer Center:
Documents provided by Jonsson Comprehensive Cancer Center:
Study Protocol and Statistical Analysis Plan [PDF] June 22, 2020
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Jonsson Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT03025139 |
| Other Study ID Numbers: |
16-000817 NCI-2016-01396 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) R01CA200977 ( U.S. NIH Grant/Contract ) |
| First Posted: | January 19, 2017 Key Record Dates |
| Last Update Posted: | July 21, 2022 |
| Last Verified: | July 2022 |
| 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:
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breast cancer younger women education |
mindfulness meditation depression cancer survivor |
Additional relevant MeSH terms:
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Breast Neoplasms Breast Carcinoma In Situ Behavioral Symptoms Neoplasms by Site Neoplasms Breast Diseases |
Skin Diseases Carcinoma in Situ Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |