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E-Mindfulness Approaches for Living After Breast Cancer

NCT06748222 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 402

Last updated 2026-04-23

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • NRG Oncology

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-27
Primary Completion
2029-02-28
Completion
2030-02-28

Countries

  • United States
  • Puerto Rico

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06748222 on ClinicalTrials.gov