Stage IIIA Breast Cancer Clinical Trial
— PTWOfficial title:
Improving Outcomes for Younger Breast Cancer Survivors: A Phase III Randomized Trial Targeting Behavioral Symptoms in Younger Breast Cancer Survivors
Verified date | July 2022 |
Source | Jonsson Comprehensive Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 96 |
Est. completion date | February 1, 2024 |
Est. primary completion date | February 1, 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A to 49 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins University/Sidney Kimmel Cancer Center | Baltimore | Maryland |
United States | Dana-Farber Cancer Institute | Boston | Massachusetts |
United States | UCLA / Jonsson Comprehensive Cancer Center | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
Jonsson Comprehensive Cancer Center | National Cancer Institute (NCI), National Institutes of Health (NIH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | Change in hot flashes measured by the vasomotor symptom severity subscale of the BCPT symptom scales questionnaire. | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Mediators of intervention efficacy assessed by questionnaire | Mediators assessed will include self-efficacy, mindfulness, self-kindness, and rumination. | Up to 6 months | |
Secondary | 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 |
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