E-Mindfulness Approaches for Living After Breast Cancer

ID#: NCT06748222

Age: 18 - 50 years

Gender: All

Healthy Subjects: No

Study Phase: N/A

Recruitment Status: Recruiting

Start Date: June 12, 2025

End Date: February 28, 2030

Contact Information:
Director Regulatory Affairs
412-339-5300
Norman Wolmark, MD
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:

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.
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