Digital mindfulness programs for life after breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

NRG-CC015 is a randomized phase III trial comparing two digital delivery methods of a mindfulness-based program (MAPs): a live instructor-led course delivered over Zoom and a self-paced app version, with a meditation-only control group. Participants are younger breast cancer survivors diagnosed at or before age 50 who completed primary treatment 6 months to 5 years earlier and have elevated depressive symptoms (PHQ-8 scores 5–14). The trial will measure changes in depressive symptoms and related mental-health and well‑being outcomes and will explore mediators (e.g., emotion regulation, rumination, self-kindness) and moderators (e.g., baseline distress, race, ethnicity, education, rurality). Findings aim to show which digital approach works best overall and for specific subgroups to guide personalized delivery of psychological support in oncology.

Why it matters

Who can join: the full rules

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.

Where it's running

• Mayo Clinic Hospital in Arizona
  Phoenix, Arizona, United States Recruiting
• Mercy Hospital Fort Smith
  Fort Smith, Arkansas, United States Recruiting
• NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
  Jonesboro, Arkansas, United States Recruiting
• University of Arkansas for Medical Sciences
  Little Rock, Arkansas, United States Recruiting
• Kaiser Permanente-Anaheim
  Anaheim, California, United States Recruiting
• Kaiser Permanente-Deer Valley Medical Center
  Antioch, California, United States Recruiting

+406 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Director Regulatory Affairs
• Email: langerj@nrgoncology.org
• Phone: 412-339-5300

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.