NCT04062552

Learning Collaborative Versus Technical Assistance in Delivering a Palliative Care Program to Patients With Advanced Cancer and Their Caregivers

Implementing Palliative Care: Learning Collaborative vs. Technical Assistance

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 208 (estimated)
• Sponsor: University of Rochester NCORP Research Base · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This trial studies the delivery of the ENABLE palliative care program by two different methods called a Virtual Learning Collaborative or Technical Assistance for patients with advanced cancer and their caregivers. Palliative care is specialized medical care for people with a serious illness that occurs at the same time as other medical treatment. The purpose of palliative care is to provide relief from symptoms and stress of serious illness, to help patients and their families clarify goals of care, and to focus on social support and spiritual well-being. 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 doctors find the best ways to include palliative care services into their practices and the impact of palliative care on cancer patients and their caregivers' quality of life.

Detailed description

PRIMARY OBJECTIVE: I. Gather preliminary data on the effectiveness of virtual learning collaborative (VLC) versus (vs.) technical assistance (TA) on educate, nurture, advise before life ends (ENABLE) program uptake, defined as the proportion of patients that complete a palliative care assessment and at least 4 ENABLE sessions. SECONDARY OBJECTIVE: I. Evaluate the preliminary effectiveness of VLC or TA on patient quality of life (QOL) and mood outcomes. II. Evaluate the relationship between ENABLE program uptake and patients' QOL and mood across the two strategies. EXPLORATORY OBJECTIVES: I. Evaluate the effectiveness of VLC vs. TA on participating institutions' overall ENABLE program implementation, as measured by the General Organizational Index (GOI). II. Evaluate the relationship between overall ENABLE program implementation and patients' QOL and mood across the two strategies. OUTLINE: Health care practice sites are randomized to 1 of 2 groups. GROUP I: Patients undergo a palliative care assessment, participate in 6 ENABLE phone-based sessions with an ENABLE coach over 20-40 minutes, and monthly follow-up calls for 6 months. Caregivers participate in 3 ENABLE sessions with an ENABLE coach and monthly follow-up calls for 6 months. The practice sites participate in a Virtual Learning Collaborative (VLC) consisting of group-based learning sessions, coaching, and applied quality improvement data collection, analysis and feedback opportunities monthly for 15 months. GROUP II: Patients undergo a palliative care assessment, participate in 6 ENABLE phone-based sessions with an ENABLE coach over 20-40 minutes, and monthly follow-up calls for 6 months. Caregivers participate in 3 ENABLE sessions with an ENABLE coach and monthly follow-up calls for 6 months. The practice sites undergo practice-based consultation calls with an ENABLE/Technical Assistance (TA) expert monthly for 15 months. After completion of the study, participants are followed up at 12 and 24 weeks.

Conditions

• Advanced Malignant Solid Neoplasm
• Metastatic Malignant Solid Neoplasm
• Recurrent Malignant Solid Neoplasm

Interventions

Type	Name	Description
OTHER	Behavioral, Psychological or Informational Intervention	Receive ENABLE palliative care information
OTHER	Educational Intervention	Participate in VLC group-based learning sessions
OTHER	Educational Intervention	Participate in consultation with ENABLE/TA expert
PROCEDURE	Medical Examination Assessment	Undergo palliative care assessment
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Survey Administration	Complete surveys
BEHAVIORAL	Telephone-Based Intervention	Receive monthly phone calls

Timeline

• Start date: 2021-03-09
• Primary completion: 2025-09-16
• Completion: 2026-08-23
• First posted: 2019-08-20
• Last updated: 2026-01-13

Locations

113 sites across 1 country: United States