Clinical Studies Search

Protocol Summary


Protocol No.
PSCI-25-079
Prinicipal Investigator
Polimera, Hyma
Phase
Phase III
Age Group
Adult
Scope
National
Secondary Protocol No.
NRG-CC015
Title
NRG-CC015: HARNESSING E-MINDFULNESS APPROACHES FOR LIVING-AFTER BREAST CANCER---HEAL-ABC A Randomized Phase III Trial Testing the Efficacy of Remote Delivery of Mindfulness Awareness Practices in the NCORP; funding to Dr. Julienne Bower, MPI (contact) and Dr. Patricia Ganz, MPI at the University of California, Los Angeles (UCLA).
Objective
Primary Objective
To determine the efficacy of Mindful Awareness Practices (MAPs) live online (LO) relative to the meditation only (MO) control group on depressive symptoms, as indicated by the difference in CES-D change score from baseline to post-intervention between the intervention and control groups.

To determine the efficacy of Mindful Awareness Practices (MAPs) App relative to the meditation only (MO) control group on depressive symptoms, as indicated by the difference in CES-D change score from baseline to post-intervention between the intervention and control groups.
Secondary Objectives
To determine the persistence of MAPs LO and MAPs App effects on depressive symptoms from baseline to 3-month and 6-month follow-up relative to the MO control group.

To determine the efficacy of MAPs LO and MAPs App relative to the MO control group on fatigue, sleep disturbance, vasomotor symptoms, fear of recurrence, well-being, and work productivity.

To assess the cost effectiveness of MAPs LO and MAPs App relative to the MO control group.

Exploratory Objectives
To explore potential mediators and moderators of intervention effects, including rumination and self-kindness (mediators), and baseline depressive symptoms, demographics, and social determinants of health (moderators).
Applicable Disease Sites
Breast
Status
Open
Participating Institutions
Hershey Medical Center