A Study to Examine Mindfulness Training to Improve Mental Health and Well-being in Younger Breast Cancer Survivors, HEAL-ABC Trial

PRIMARY OBJECTIVES:

I. 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 Center for Epidemiologic Studies – Depression (CES-D) change score from baseline to post-intervention between the intervention and control groups.

II. 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:

I. 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.

II. 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.

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

EXPLORATORY OBJECTIVE:

I. 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).

OUTLINE: English speaking patients are randomized to 1 of 3 arms. Spanish speaking patients are randomized to arm 1 or 3.

ARM 1 (MAPs LO): Patients attend online zoom group sessions over 2 hours once weekly (QW) for 6 weeks. Patients practice mindfulness techniques using guided meditations over 5-20 minutes once daily (QD).

ARM 2 (MAPS DIGITAL APP): Patients access MAPs App over up to 3 hours QW for 6 weeks.

ARM 3 (MO CONTROL GROUP): Patients receive access to guided audio mindfulness meditations on study.

After completion of study intervention, patients are followed for up to 6 months.