NCT06748222

E-Mindfulness Approaches for Living After Breast Cancer

Harnessing E-Mindfulness Approaches for Living After Breast Cancer-HEAL-ABC

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 402 (estimated)
• Sponsor: NRG Oncology · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The goal of this trial is to determine if a digital mindfulness meditation-based intervention program can improve the mental health and well-being among younger breast cancer survivors with elevated symptoms of depression. Mindfulness meditation programs provided in person have been shown to be helpful for younger breast cancer survivors. This study will compare different digital approaches for mindfulness training to see which is the most effective. This study will also explore mediators and moderators of intervention effects, which is key for efficiently targeting psychological resources in the oncology setting and may be particularly relevant for deciding between digital intervention approaches for individual patients. Research on moderators of in-person mindfulness-based interventions (MBIs) in cancer populations suggests that patients with worse psychological functioning at study entry tend to benefit more from these interventions, with mixed effects for other predictors. It is unclear whether more distressed patients will show similar benefits in digital interventions that lack in-person check-ins and monitoring by instructors. Thus, investigators will assess baseline distress along with key demographic characteristics and social determinants of health (e.g., race, ethnicity, education, rurality) as potential moderators. With respect to mediators, emotion regulation strategies including rumination and self-kindness have been shown to mediate effects of in-person MBIs on stress and depression in cancer populations, consistent with the broader theoretical and empirical literature on mindfulness. Determining whether these factors predict and explain effects of digital MBIs, and whether these effects differ by delivery mode, is necessary for achieving optimal outcomes of these interventions. Further, investigators will collect information on the cost-effectiveness of these programs, which is critical for payors to make coverage decisions, healthcare providers and employers to make adoption decisions, and patients to make participation decisions.

Conditions

• Breast Cancer
• Depression

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-06-12
• Primary completion: 2029-02-28
• Completion: 2030-02-28
• First posted: 2024-12-27
• Last updated: 2026-04-02

Locations

299 sites across 2 countries: United States, Puerto Rico