E-Mindfulness Approaches for Living After Breast Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-50
SponsorNRG Oncology
About this trial
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
Qualifiers
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).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Mindfulness (MAPs) Live Online
- Mindfulness (MAPs) Digital App
- Meditation Only Control Group
Treatment groups
402 Participants
are divided into 3 treatment groupsSponsors and collaborators
NRG Oncology
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov