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Harnessing E-Mindfulness Approaches for Living After Breast Cancer-HEAL-ABC
NRG-CC015 is a prospective, randomized phase III clinical trial to evaluate the efficacy of two distinct digital approaches for delivering a mindfulness-based intervention: a live, instructor-led version delivered over Zoom (MAPs LO), and an app-based, self-paced version (MAPs App). Participants will include younger breast cancer survivors (BCS) who were diagnosed with breast cancer at or before age 50 years, have completed their primary cancer treatment (i.e., surgery, radiation, and/or chemotherapy) at least 6 months earlier, and report elevated depressive symptoms.
Eligibility Criteria
Inclusion Criteria
- 1The participant or a legally authorized representative must provide study-specific informed consent prior to pre-entry and, for participants treated in the U.S., authorization permitting release of personal health information.
- 2The participant must have been greater than or equal to 18 or less than or equal to 50 years of age at the time of breast cancer diagnosis.
- 3The participant must have a first-time diagnosis of non-metastatic breast cancer which is Stage 0, I, II, or III.
- 4The participant must have a score of greater than or equal to 5 and less than or equal to 14 on the Patient Health Questionnaire-8 item (PHQ-8).
- 5Participants must have completed all primary breast cancer treatments at least 6 months prior to and no more than 5 years prior to registration. Note: Primary treatments include surgery, radiation therapy, adjuvant chemotherapy, targeted therapies (e.g., PARP (poly-ADP ribose polymerase) inhibitors, CDK4/6 inhibitors, TDM-1, pertuzumab, or immunotherapy). (Participants may still be taking adjuvant therapy with trastuzumab or adjuvant endocrine therapy or completing minor reconstructive surgery.)
- 6Participant must be able to understand, speak, read, and write in English or Spanish.
- 7Participant must be willing to participate in a 6-week program to receive training in mindfulness.
- 8Participant must be able to use a smartphone, tablet, or other digital device.
- 9Sex assigned at birth must be female.
Exclusion Criteria
- 1Patient Health Questionnaire-8 item (PHQ-8) score of less than 5 or greater than 14 .
- 2Any history or current evidence of recurrent or metastatic breast cancer.
- 3Current or past history of another cancer. Participants with a history of only non-melanoma skin cancer or in situ cervical cancer without chemotherapy treatment would be eligible.
- 4Currently pregnant or planning to become pregnant in the near future.
- 5Participants who are enrolled in other cancer control or behavioral intervention trials that require frequent assessments or training activities.
Locations
199 sites participating in this study
Emory University Hospital Midtown
Atlanta, Georgia 30308
Mylin A. Torres
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia 30322
Mylin A. Torres
Emory Saint Joseph's Hospital
Atlanta, Georgia 30342
Mylin A. Torres