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.
E-Mindfulness Approaches for Living After Breast Cancer
NRG-CC015: Harnessing E-Mindfulness Approaches for Living After Breast Cancer-HEAL-ABC
Breast cancer, Depression
All genders
18-50
Recruiting now
Overview
Principal Investigator: Don Dizon, MD
Contact Us
Latoya Marshall
Study details
Inclusion Criteria
- The 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.
- The 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.
- The participant must have a first-time diagnosis of non-metastatic breast cancer which is Stage 0, I, II, or III.
Exclusion Criteria
- Patient Health Questionnaire-8 item (PHQ-8) score of less than 5 or greater than 14.
- Any history or current evidence of recurrent or metastatic breast cancer.
- Current 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.
Study Requirements
Behavioral: Mindfulness (MAPs) Live Online
Exercises include breath, body, and sound meditations; eating and walking meditations; managing pain; working with difficult thoughts and emotions; and cultivating loving kindness. Home practice is a key component of MAPs, and participants will be instructed to practice mindfulness techniques daily, beginning with 5 minutes daily and increasing to 20 minutes daily using guided meditations. Attendance in the group sessions and home practice will be tracked to determine "dose" of the intervention received.
Behavioral: Mindfulness (MAPs) Digital App
The digital program is sequential with new content and exercises building on previous sessions. Lessons and other materials are gradually unlocked as participants progress through the program. Engagement with the MAPs App will be tracked to determine "dose" of the intervention received.
Behavioral: Meditation Only Control Group
Use of the meditations will be tracked to determine "dose" of the intervention received.