Learning Collaborative Vs Technical Assistance in Delivering a Palliative Care Program to Patients With Advanced Cancer

Advanced Solid Tumor Clinical Trial

Official title: Implementing Palliative Care: Learning Collaborative vs. Technical Assistance

Status Enrolling by invitation

Clinical Trial Summary

This trial studies the delivery of the ENABLE palliative care program for patients with advanced cancer. The study compares two methods for delivering ENABLE: Virtual Learning Collaborative (VLC) and Technical Assistance (TA). The focus of the ENABLE palliative care program is on living well, managing stress, patient communication of their personal values and hopes for care, social support, and symptom management. This study may help practices to incorporate ENABLE palliative care services and improve overall mood and quality of life for patients with advanced cancer.

Clinical Trial Description

This cluster-randomized controlled study evaluates two strategies to implement the ENABLE (Educate, Nurture, Advise, Before Life Ends) early palliative care (EPC) program, while gathering additional information on the ENABLE clinical program and related outcomes. The primary aim is to gather preliminary data on the effectiveness of VLC or TA on ENABLE program uptake, defined as the proportion of patients that complete a Palliative Care Assessment and at least 4 ENABLE sessions. Secondary aims evaluate the preliminary effectiveness of VLC or TA on patient-level outcomes and the relationship between ENABLE program uptake and patient outcomes. Exploratory aims evaluate the preliminary effectiveness of VLC or TA on overall ENABLE program implementation, as measured by the General Organizational Index (GOI) and the relationship between overall ENABLE program implementation and patient outcomes.

To achieve the study aims, at least 16 participating sites will be randomized to the Virtual Learning Collaborative study arm (VLC, n = 8 practices) or the Technical Assistance study arm (TA, n = 8 practices). Participating sites randomized to the VLC will have access to monthly group calls with an ENABLE expert and a quality improvement expert for up to 65 weeks. Participating sites randomized to TA will have access to monthly technical assistance support for their practice for up to 65 weeks. Each practice cluster will have a recruitment goal of 13 patients (target n=208 patients total; 104 patients per arm; allowable range per practice cluster 8-25). To account for practice clusters that may be unable to recruit at least 13 patients, we will include an option to recruit 4 additional practices per study arm. Patients who agree to participate in this study will consent to a clinician-led clinical Palliative Care Assessment and up to 6 semi-structured ENABLE telehealth 20-45 minute sessions, and up to 6 monthly follow-up calls over 26 weeks with an ENABLE Coach. Patients will complete assessments of mood and quality of life at baseline (within 14 days of study enrollment), 12 weeks (±2 weeks) and 24 weeks (±2 weeks). ;

Related Conditions & MeSH terms

• Advanced Solid Tumor

• NCT number: NCT04062552
• Study type: Interventional
• Source: University of Rochester
• Status: Enrolling by invitation
• Phase: N/A
• Start date: July 6, 2021
• Completion date: September 30, 2025