Mindfulness Meditation or Survivorship Education in Improving Behavioral Symptoms in Younger Stage 0-III Breast Cancer Survivors (Pathways to Wellness)

Stage IIIA Breast Cancer Clinical Trial

— PTW  

Official title:

Improving Outcomes for Younger Breast Cancer Survivors: A Phase III Randomized Trial Targeting Behavioral Symptoms in Younger Breast Cancer Survivors

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03025139
• Other study ID #: 16-000817
• Secondary ID: NCI-2016-01396R0
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 20, 2017
• Est. completion date: February 1, 2024

Study information

• Verified date: July 2022
• Source: Jonsson Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Behavioral Symptoms
• Breast Carcinoma In Situ
• Breast Neoplasms
• 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

Intervention

Other:
• Educational Intervention
Attend survivorship education
• Laboratory Biomarker Analysis
Correlative studies

Procedure:
• Meditation Therapy
Attend mindfulness meditation

Other:
• Questionnaire Administration
Ancillary studies

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
Jonsson Comprehensive Cancer Center	National Cancer Institute (NCI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

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