NCT03025139

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: Female
• Age: 49 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• 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

Interventions

Type	Name	Description
OTHER	Educational Intervention	Attend survivorship education
OTHER	Laboratory Biomarker Analysis	Correlative studies
PROCEDURE	Meditation Therapy	Attend mindfulness meditation
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2017-02-20
• Primary completion: 2023-02-01
• Completion: 2024-02-01
• First posted: 2017-01-19
• Last updated: 2022-07-21

Locations

3 sites across 1 country: United States