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.
