E-Mindfulness Approaches for Living After Breast Cancer

Conditions

• Breast Cancer
• Depression

Eligibility Criteria

Sex

ALL

Age

18 Years - 50 Years

Healthy Volunteers

Not accepted

Interventions

• Mindfulness (MAPs) Live Online — BEHAVIORAL
  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.
• Mindfulness (MAPs) Digital App — BEHAVIORAL
  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.
• Meditation Only Control Group — BEHAVIORAL
  Use of the meditations will be tracked to determine "dose" of the intervention received.

Study Details

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.

Key Dates

Start date

Jun 27, 2025

Status verified

Jun 2026

Primary completion

Feb 28, 2029

Completion

Feb 28, 2030

Study Design

Enrollment

402 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Experimental: Mindfulness (MAPs) Live Online
  Participants assigned to MAPs Live Online (MAPs LO) will be asked to attend 2-hour group sessions once a week for 6 weeks conducted live online over Zoom. Both English and Spanish language participants will be randomized to Arm 1. Sessions will be conducted on an encrypted internet connection and recorded for quality assurance and intervention fidelity. Participants who do not have a home computer, smartphone, tablet, or internet to access the Zoom sessions will have a tablet and hotspot provided by the UCLA research team. Each session provides structured lessons and guided exercises in mindfulness as well as opportunities for reflection and group discussion. 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
• Experimental: Mindfulness (MAPs) Digital App
  Participants assigned to this condition will be asked to access the MAPs App on their home computer, smartphone, or study supplied tablet over the 6-week intervention period. This will be provided by the UCLA research team. Only English language speakers will be assigned to Arm 2, as the app is currently available only in English at this time. Participants who do not have a home computer, smartphone, tablet, or internet to access the digital app will be provided with a tablet and hotspot by the UCLA research team. The MAPs App translates the content of the MAPs intervention into an app-based format, with lessons, exercises, and guided discussions from the six 2-hour sessions separated into shorter micro-sessions. 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 inte
• Active Comparator: Meditation Only Control Group
  The participants assigned to this condition will be provided with access to guided audio mindfulness meditations developed by the UCLA MARC (Mindfulness Awareness Research Center) and available on an app. Both English and Spanish speakers will be assigned to Arm 3, and the meditations will be available in both languages. Participants who do not have a home computer, smartphone, tablet, or internet to access the meditations will be provided with a tablet and hotspot by the UCLA research team. Use of the meditations will be tracked to determine "dose" of the intervention received. All three study groups will have access to the UCLA MARC mindfulness meditation app throughout the study duration out to 6 months of follow-up.

Primary Outcome Measure

Self-reported depressive symptoms measured-post intervention in the Mindful Awareness Practices (MAPs) live online (LO) and the meditation only (MO) groups [ Time Frame: 2 weeks post-intervention ]

Central Contacts

• Director Regulatory Affairs
  412-339-5300
  [email protected]
• Norman Wolmark, MD

Locations (332)

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