Recruiting

E-Mindfulness Approaches for Living After Breast Cancer

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…

ClinicalTrials.gov IDNCT06748222

PhasePHASE3

Enrollment402

SponsorNRG Oncology

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Breast Cancer, Depression

About this study

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.

Primary outcomes

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

Eligibility information

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. * 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. 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. * 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.

Study locations

Mayo Clinic Hospital in Arizona, Phoenix, Arizona 85054 United States
Mercy Hospital Fort Smith, Fort Smith, Arkansas 72903 United States
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro, Jonesboro, Arkansas 72401 United States
University of Arkansas for Medical Sciences, Little Rock, Arkansas 72205 United States
Kaiser Permanente-Anaheim, Anaheim, California 92806 United States
Kaiser Permanente-Deer Valley Medical Center, Antioch, California 94531 United States
AIS Cancer Center at San Joaquin Community Hospital, Bakersfield, California 93301 United States
Kaiser Permanente-Baldwin Park, Baldwin Park, California 91706 United States
Kaiser Permanente-Bellflower, Bellflower, California 90706 United States
Marshall Cancer Center, Cameron Park, California 95682 United States

Showing 10 of 383 reported sites. See the official listing for all locations.

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.