A Pilot RCT of a Digitally-Enhanced Community Health Worker-led Intervention for Early Stepped Palliative Care in Hepatobiliary Cancers

Abstract public domain (NIH RePORTER)

Hepatopancreatobiliary (HPB) cancers will become the primary cause of cancer mortality by 2030. These patients have substantial morbidity, including high symptom burden and poor quality of life. While early palliative care (PC) can improve symptoms and quality of life, there are low rates of PC utilization in HPB cancers, with PC primarily being used at the end of life, limiting the breadth of assistance PC can offer. Thus, innovative, equitable, and scalable, community-based PC interventions are needed to facilitate early PC in patients with HPB malignancies. Community health workers (CHWs) are frontline public health workers trusted by the communities they serve. In preliminary studies, we developed a digitally enhanced CHW-led intervention that delivers early-stage PC care, navigation, and clinical trial engagement, and provides resources to help alleviate the financial burden of cancer treatment (PAL-CHW-PDAC intervention). This intervention was feasible and acceptable and reduced symptom burden in a pilot study. However, hepatobiliary (HB) cancers have distinct differences from PDAC, including underlying liver dysfunction contributing to symptoms and limiting palliative procedures and medications, and improved prognosis in early-stage and intermediate-stage patients requiring a tailored intervention. The current proposal will adapt the prior PAL-CHW-PDAC intervention to patients/caregivers with HB cancers. We will first use key informant interviews to capture patient, caregiver, and CHW perspectives toward the disease course, treatments, and role of PC in HB cancers. We will then utilize these perspectives, along with input from healthcare professionals, to adapt the PAL-CHW-PDAC intervention for hepatobiliary cancers. We will subsequently conduct a pilot feasibility study with 24 patients to assess its feasibility and acceptability, followed by a pilot RCT enrolling 70 patients/caregivers to get a preliminary estimate of efficacy. The candidate's overall career goals are to design and lead clinical trials, comparative effectiveness, and implementation studies for PC interventions. The career development goals include developing expertise in implementation science, including advanced qualitative methodology, clinical trial design, and using frameworks to design and adapt interventions. This training plan includes strong mentorship, formal coursework, including completing a certificate in implementation science, seminars, and laboratory meetings to execute this career development plan. This proposal investigates a potentially transformative intervention that addresses the critical gap in early PC utilization in HPB malignancies for early detection and intervention for symptoms. This represents the blueprint for developing the applicant into an independent clinical investigator.

Public health relevance public domain (NIH RePORTER)

Despite early palliative care improving symptoms and quality of life in hepatopancreatobiliary cancers, palliative care utilization occurs late in the disease course, limiting the breadth of the assistance palliative care can offer these patients. We previously developed a novel community health worker-led intervention that delivers early stepped palliative care, care navigation, clinical trial engagement, and addresses financial toxicity in pancreatic cancer patients, but we are lacking such an intervention for hepatobiliary malignancies. The proposed studies will capture patient and caregiver perspectives towards treatment and palliative care, adapt the prior intervention to the unique needs of hepatobiliary malignancies, and then study its feasibility and preliminary efficacy in pilot studies.