Harnessing E-Mindfulness Approaches for Living After Breast Cancer-HEAL-ABC
NRG Oncology
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.
Description
The goal of this trial is to determine if a digital mindfulness meditation-based intervention program can improve the mental health and well-being among younger breast cancer survivors with elevated symptoms of depression. Mindfulness meditation programs provided in person have been shown to be helpful for younger breast cancer survivors. This study will compare different digital approaches for mindfulness training to see which is the most effective. This study will also explore mediators and moderators of intervention effects, which is key for efficiently targeting psychological resources in…
Eligibility
- Age range
- 18–50 years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- BehavioralMindfulness (MAPs) Live Online
Exercises include breath, body, and sound meditations; eating and walking meditations; managing pain; working with difficult thoughts and emotions; and cultivating loving kindness. Home practice is a key component of MAPs, and participants will be instructed to practice mindfulness techniques daily, beginning with 5 minutes daily and increasing to 20 minutes daily using guided meditations. Attendance in the group sessions and home practice will be tracked to determine "dose" of the intervention received.
- BehavioralMindfulness (MAPs) Digital App
The digital program is sequential with new content and exercises building on previous sessions. Lessons and other materials are gradually unlocked as participants progress through the program. Engagement with the MAPs App will be tracked to determine "dose" of the intervention received.
- BehavioralMeditation Only Control Group
Use of the meditations will be tracked to determine "dose" of the intervention received.
Locations (299)
- Mayo Clinic Hospital in ArizonaPhoenix, Arizona
- Mercy Hospital Fort SmithFort Smith, Arkansas
- Kaiser Permanente-Deer Valley Medical CenterAntioch, California
- AIS Cancer Center at San Joaquin Community HospitalBakersfield, California
- Marshall Cancer CenterCameron Park, California
- Enloe Medical CenterChico, California