E-Mindfulness Approaches for Living After Breast Cancer

Recruiting now · Phase 3

Conditions studied: Breast Cancer, Depression

In brief

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 facts

Study ID

NCT06748222

Run by

NRG Oncology

People needed

402

Starts

2025-06-27

Expected to finish

2030-02-28

Last updated by the study team

2026-08-04

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• The 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).
• Participants 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.)
• Participant must be able to understand, speak, read, and write in English or Spanish.
• Participant must be willing to participate in a 6-week program to receive training in mindfulness.
• Participant must be able to use a smartphone, tablet, or other digital device.
• Sex assigned at birth must be female.

You may not qualify if…

• 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.
• Currently pregnant or planning to become pregnant in the near future.
• Participants who are enrolled in other cancer control or behavioral intervention trials that require frequent assessments or training activities.

Where it is running

• Mercy Hospital Fort Smith — Fort Smith, Arkansas, United States (enrolling)
• NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro — Jonesboro, Arkansas, United States (enrolling)
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States (enrolling)
• Kaiser Permanente-Anaheim — Anaheim, California, United States (enrolling)
• Kaiser Permanente-Deer Valley Medical Center — Antioch, California, United States (enrolling)
• AIS Cancer Center at San Joaquin Community Hospital — Bakersfield, California, United States (enrolling)
• Kaiser Permanente-Baldwin Park — Baldwin Park, California, United States (enrolling)
• Kaiser Permanente-Bellflower — Bellflower, California, United States (enrolling)
• Marshall Cancer Center — Cameron Park, California, United States (enrolling)
• Enloe Medical Center — Chico, California, United States (enrolling)
• UC Irvine Health Cancer Center-Newport — Costa Mesa, California, United States (enrolling)
• Kaiser Permanente Dublin — Dublin, California, United States (enrolling)
• Kaiser Permanente-Fontana — Fontana, California, United States (enrolling)
• Kaiser Permanente-Fremont — Fremont, California, United States (enrolling)
• Washington Health — Fremont, California, United States (enrolling)
• Kaiser Permanente Fresno Orchard Plaza — Fresno, California, United States (enrolling)
• Kaiser Permanente-Fresno — Fresno, California, United States (enrolling)
• Kaiser Permanente South Bay — Harbor City, California, United States (enrolling)
• UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care — Irvine, California, United States (enrolling)
• Kaiser Permanente-Irvine — Irvine, California, United States (enrolling)
• Kaiser Permanente Los Angeles Medical Center — Los Angeles, California, United States (enrolling)
• Los Angeles General Medical Center — Los Angeles, California, United States (enrolling)
• USC / Norris Comprehensive Cancer Center — Los Angeles, California, United States (enrolling)
• Kaiser Permanente West Los Angeles — Los Angeles, California, United States (enrolling)
• Mayo Clinic Hospital in Arizona — Phoenix, Arizona, United States (enrolling)

Full record on ClinicalTrials.gov

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