Mindfulness Meditation or Survivorship Education in Improving Behavioral Symptoms in Younger Stage 0-III Breast Cancer Survivors (Pathways to Wellness)
PTW
Improving Outcomes for Younger Breast Cancer Survivors: A Phase III Randomized Trial Targeting Behavioral Symptoms in Younger Breast Cancer Survivors
3 other identifiers
interventional
96
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2017
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 17, 2017
CompletedFirst Posted
Study publicly available on registry
January 19, 2017
CompletedStudy Start
First participant enrolled
February 20, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2024
CompletedJuly 21, 2022
July 1, 2022
6 years
January 17, 2017
July 18, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (6)
Change in fatigue assessed by Fatigue Symptom Inventory
2 weeks post-intervention to 6 months
Change in hot flashes measured by the vasomotor symptom severity subscale of the BCPT symptom scales questionnaire.
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)
2 weeks post-intervention to 6 months
Change in sleep disturbance assessed by Insomnia Severity Index
2 weeks post-intervention to 6 months
Mediators of intervention efficacy assessed by questionnaire
Up to 6 months
- +1 more secondary outcomes
Study Arms (3)
Arm A (MAPs)
ACTIVE COMPARATORPatients 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.
Arm B (SE)
ACTIVE COMPARATORPatients 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)
ACTIVE COMPARATORPatients receive usual care for 9 months. Patients are then offered a choice of participating in Arm A or Arm B.
Interventions
Attend survivorship education
Correlative studies
Attend mindfulness meditation
Ancillary studies
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jonsson Comprehensive Cancer Centerlead
- National Cancer Institute (NCI)collaborator
- National Institutes of Health (NIH)collaborator
Study Sites (3)
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095, United States
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Related Publications (4)
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.
PMID: 39132946DERIVEDTyrus 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.
PMID: 38917400DERIVEDBower 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.
PMID: 36130057DERIVEDBower 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.
PMID: 34406839DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Patricia Ganz
UCLA / Jonsson Comprehensive Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 17, 2017
First Posted
January 19, 2017
Study Start
February 20, 2017
Primary Completion
February 1, 2023
Study Completion
February 1, 2024
Last Updated
July 21, 2022
Record last verified: 2022-07