BOLSTER: Strengthening Patient and Caregiver Supports in Advanced Cancer - a Multi-Site Randomized Controlled Trial - PROJECT SUMMARY This proposal aims to test the efficacy of BOLSTER, a multi-component primary palliative care intervention designed to improve quality of life, mitigate symptoms, and reduce burdensome hospital-based care for patients with complex care needs from advanced solid tumors, including gastrointestinal, gynecologic, breast and lung cancers (GI/GYN/breast/lung). These cancers account for two-thirds of US cancer deaths and cause tremendous suffering. They often spread aggressively through the peritoneum and invade through pelvic organs, causing bowel obstructions, refractory ascites, ureteral and biliary obstructions, pelvic fistulas and non-healing wounds. Palliating these devastating complications requires interventions such as venting gastric tubes, ostomies, and peritoneal and pleural catheters—leaving patients and family caregivers to cope with extremely complex care needs, severe symptoms, frequent complications and rehospitalizations. In response to this great need, we developed BOLSTER, a multi-component primary palliative care intervention that combines 1) a longitudinal relationship among a nurse, patient, and family caregiver with structured telehealth contacts; 2) a mobile health platform with electronic patient-reported outcomes to assess symptoms and trigger clinical action between office visits; and 3) tailored patient and caregiver symptom management and skills training. BOLSTER has proven feasible and acceptable in pilot randomized trial, with most patients reporting it improved symptoms (70%), helped coping (80%), and recommending it highly (95%). Here we propose a multi-center randomized controlled trial of BOLSTER versus usual care (UC) among 400 patients with complex care needs from advanced GI/GYN/breast/lung cancers and their family caregivers. In a lead-in phase we will adapt all study materials into Spanish for those participants who are not native English speakers. Mirroring real-world care settings, the trial will enroll patient-caregiver dyads who receive their primary cancer care at two major cancer centers, eight affiliated community oncology practices, and a large safety-net hospital. Our Specific Aims are to 1) determine the effects of BOLSTER on patient QOL, as mediated by symptoms, self-efficacy for managing them, and health care utilization; 2) determine the effects of BOLSTER on caregiver burden, distress, and self-efficacy; and 3) using the RE-AIM model, characterize site-specific barriers and facilitators to implementation to understand the necessary components for optimal scalability and sustainability. Our project is innovative in using bilingual nurses to deliver a telehealth intervention that provides critical skills training, self-management support, and an mHealth platform to proactively manage symptoms. If efficacious, BOLSTER will be a highly scalable model, primed for a large, multisite implementation trial.
