Recruitment

Recruitment Status
Enrolling by invitation
Estimated Enrollment
720

Summary

Conditions
  • Advanced Malignant Solid Neoplasm
  • Caregiver
  • Metastatic Malignant Solid Neoplasm
  • Nurse
  • Nurse Practitioner
  • Oncologist
  • Physician Assistant
  • Progressive Neoplastic Disease
  • Recurrent Malignant Solid Neoplasm
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Health Services Research

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

PRIMARY OBJECTIVES: I. Compare the effectiveness of Virtual Learning Collaborative (VLC) versus (vs.) Technical Assistance (TA) on Educate, Nurture, Advise, Before Life Ends (ENABLE) program uptake, as measured by the proportion of patients who complete the ENABLE program, defined as having a pallia...

PRIMARY OBJECTIVES: I. Compare the effectiveness of Virtual Learning Collaborative (VLC) versus (vs.) Technical Assistance (TA) on Educate, Nurture, Advise, Before Life Ends (ENABLE) program uptake, as measured by the proportion of patients who complete the ENABLE program, defined as having a palliative care assessment and completing the 6 ENABLE sessions. (Implementation Outcome, Patient Level) SECONDARY OBJECTIVES: I. Compare the effectiveness of VLC vs. TA on National Cancer Institute Oncology Research Program (NCORP) practices' overall ENABLE program implementation, as measured by the General Organizational Index (GOI) (Service Outcome, Practice Level) EXPLORATORY OBJECTIVES: I. Compare NCORP practices randomized to VLC or TA on patient and caregiver quality of life (QOL) and mood outcomes. (Patient & Caregiver Outcomes) II. Determine the relationship among ENABLE program uptake, 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 a nurse coach over 20-40 minutes, and monthly follow-up calls for 6 months. Caregivers participate in 3 ENABLE sessions with a nurse 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 a nurse coach over 20-40 minutes, and monthly follow-up calls for 6 months. Caregivers participate in 3 ENABLE sessions with a nurse 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.

Tracking Information

NCT #
NCT04062552
Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Lisa Zubkoff, PhD Dartmouth College