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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2016-01396 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| R01CA200977 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| National Institutes of Health (NIH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A (MAPs) | Active Comparator | 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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| Arm B (SE) | Active Comparator | 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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| Arm C (USUAL CARE/DELAYED TREATMENT CONTROL GROUP) | Active Comparator | 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Educational Intervention | Other | Attend survivorship education |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in depressive symptoms measured by Center for Epidemiologic Studies Depression Scale score | 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. | 2 weeks post-intervention to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in fatigue assessed by Fatigue Symptom Inventory | Will be tested using the mixed modeling approach, and p-values reported both with and without multiplicity adjustment. All tests will be two-sided. | 2 weeks post-intervention to 6 months |
| Change in hot flashes measured by the vasomotor symptom severity subscale of the BCPT symptom scales questionnaire. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patricia Ganz | UCLA / Jonsson Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA / Jonsson Comprehensive Cancer Center | Los Angeles | California | 90095 | United States | ||
| Johns Hopkins University/Sidney Kimmel Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39132946 | Derived | Korecki JRT, Ganz PA, Partridge AH, Wolff AC, Petersen L, Crespi CM, Bower JE. Mediators of a Mindfulness-Based Intervention for Younger Breast Cancer Survivors: Effects on Depressive Symptoms. Psychosom Med. 2024 Oct 1;86(8):700-709. doi: 10.1097/PSY.0000000000001340. Epub 2024 Aug 10. | |
| 38917400 | Derived | Tyrus Korecki JR, Ganz PA, Partridge AH, Wolff AC, Petersen L, Crespi CM, Bower JE. Moderators of Intervention Efficacy in the Pathways to Wellness Trial of Survivorship Education and Mindfulness Meditation for Younger Breast Cancer Survivors. JCO Oncol Pract. 2024 Oct;20(10):1410-1419. doi: 10.1200/OP.23.00617. Epub 2024 Jun 25. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 18, 2023 | |
| Reset | Jun 13, 2023 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 22, 2020 |
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| Laboratory Biomarker Analysis | Other | Correlative studies |
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| Meditation Therapy | Procedure | Attend mindfulness meditation |
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| Questionnaire Administration | Other | Ancillary studies |
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Will be tested using the mixed modeling approach, and p-values reported both with and without multiplicity adjustment. All tests will be two-sided. |
| 2 weeks post-intervention to 6 months |
| Change in inflammatory biomarkers will focus on laboratory measurements of Interleukin-6 (IL-6) and high sensitivity C-Reactive Protein (hsCRP) | Will be tested using the mixed modeling approach, and p-values reported both with and without multiplicity adjustment. All tests will be two-sided. | 2 weeks post-intervention to 6 months |
| Change in sleep disturbance assessed by Insomnia Severity Index | Will be tested using the mixed modeling approach, and p-values reported both with and without multiplicity adjustment. All tests will be two-sided. | 2 weeks post-intervention to 6 months |
| Mediators of intervention efficacy assessed by questionnaire | Mediators assessed will include self-efficacy, mindfulness, self-kindness, and rumination. | Up to 6 months |
| Moderators of intervention efficacy assessed by questionnaire | Moderators will include preparedness for survivorship, intervention preference, and childhood adversity. Will be assessed using condition-by-moderator interaction terms in mixed models. | Up to 6 months |
| Baltimore |
| Maryland |
| 21287 |
| United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
| 36130057 | Derived | 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. |
| 34406839 | Derived | 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. |
| Jul 6, 2022 |
| Prot_SAP_000.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 18, 2023 | Jun 13, 2023 |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D000071960 | Breast Carcinoma In Situ |
| D003863 | Depression |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D002278 | Carcinoma in Situ |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D018479 | Early Intervention, Educational |
| D004522 | Educational Status |
| D008722 | Methods |
| D019122 | Meditation |
| ID | Term |
|---|---|
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D011314 | Preventive Health Services |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
| D008919 | Investigative Techniques |
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026443 | Spiritual Therapies |
| D012064 | Relaxation Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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