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Digital mindfulness programs for life after breast cancer

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

Phase 3 Interventional NRG Oncology · NCT06748222

This trial will test whether a live Zoom mindfulness class or a self‑paced app can help younger breast cancer survivors with mild-to-moderate depressive symptoms.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment402 (estimated)
Ages18 Years to 50 Years
SexAll
SponsorNRG Oncology Academic / other
Drugs / interventionspertuzumab, trastuzumab, chemotherapy, immunotherapy, radiation
Locations299 sites (Phoenix, Arizona and 298 other locations)
Trial IDNCT06748222 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are younger (diagnosed at ≤50) survivors of non‑metastatic breast cancer (stage 0–III) who finished primary treatment 6 months to 5 years ago and have mild-to-moderate depressive symptoms (PHQ‑8 5–14).

Not a fit: Patients with severe depression (PHQ‑8 >14), metastatic disease, those still undergoing primary cancer treatment, or those who prefer or require in‑person psychotherapy may not benefit from these digital-only interventions.

Why it matters

Potential benefit: If successful, the intervention could reduce depressive symptoms and improve well‑being while offering scalable, remote support for younger breast cancer survivors.

How similar studies have performed: In-person mindfulness-based programs have shown benefit for younger breast cancer survivors, while digital mindfulness interventions are promising but less well established and require phase III evidence.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Phoenix, Arizona and 298 other locations

+249 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Breast CancerDepressionMindfulnessMeditationDigital
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.