BOLSTER: Strengthening Patient and Caregiver Supports in Advanced Gynecologic and Gastrointestinal Cancers - a Multi-Site Randomized Controlled Trial

PROJECT SUMMARY The goal of this proposal is to determine 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 one of the most vulnerable of all populations: patients with complex care needs from advanced gastrointestinal and gynecologic (GI/GYN) cancers. GI/GYN cancers account for over 30% of US cancer deaths and cause tremendous suffering. These cancers 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 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 cancer and their family caregivers. In a lead-in phase we will adapt all study materials into Spanish, given that Latinos are the largest minority population in the US. 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 serving richly diverse populations and a high proportion of Latino patients. 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 understand the RE-AIM model, c barriers and facilitators to implementation to the necessary components for optimal scalability and sustainability haracterize site-specific . 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.