NCT06748222 E-Mindfulness Approaches for Living After Breast Cancer
| NCT ID | NCT06748222 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | NRG Oncology |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 402 participants |
| Start Date | 2025-06-27 |
| Primary Completion | 2029-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 402 participants in total. It began in 2025-06-27 with a primary completion date of 2029-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06748222 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 50 Years, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06748222 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 402 participants.
Is NCT06748222 currently recruiting?
Yes, NCT06748222 is actively recruiting participants. Contact the research team at langerj@nrgoncology.org for enrollment information.
Where is the NCT06748222 trial being conducted?
This trial is being conducted at Phoenix, United States, Fort Smith, United States, Jonesboro, United States, Little Rock, United States and 11 additional locations.
Who is sponsoring the NCT06748222 clinical trial?
NCT06748222 is sponsored by NRG Oncology. The trial plans to enroll 402 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.