Efficacy of Mindfulness-Based Intervention on Spiritual Outcomes in Women with Advanced Cancer: Study Protocol of a Randomized Controlled Trial

Objective: Few randomized controlled trials (RCTs) have examined the impact of mindfulness-based interventions on spirituality. In the proposed study, we aim to assess the efficacy of a second-generation mindfulness intervention (SG-MBI) on spiritual distress, spiritual decline, and spiritual growth in women with advanced cancer. A secondary aim is to examine the impact of the intervention on psychological distress, including anxiety and depressive symptoms, loneliness, nonattachment to self, and self-transcendent states. A third aim is to explore any benefit of nature immersion on intervention outcomes. Method: This study will utilize a three-arm RCT with wait-list control design. A total of 198 women will be randomly assigned to one of two intervention groups (treatment indoors/outdoors) or wait-list control group. Participants in the 8-week intervention groups will be introduced to Buddhist-derived wisdom practices that draw upon the sublime attitudes or abodes (Sanskrit: brahmavihārā): compassion (Sanskrit: karuṇā), loving kindness (Sanskrit: maitrī), appreciative joy (muditā), and equanimity (Sanskrit: upekṣā). Assessments will be conducted at three time points: before random allocation and post-intervention at 8 weeks and 20 weeks. Proposed Analytic Plan: Linear mixed models will be used for intention-to-treat (ITT) primary analyses. Per-protocol (PP), subgroup, and secondary outcome analyses will also be conducted. Results will provide critical information about the utility of SG-MBIs for meeting the spiritual and psychological needs of women with advanced cancer.