Status:
ACTIVE_NOT_RECRUITING
Learning Collaborative Versus Technical Assistance in Delivering a Palliative Care Program to Patients With Advanced Cancer and Their Caregivers
Lead Sponsor:
University of Rochester NCORP Research Base
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Advanced Malignant Solid Neoplasm
Metastatic Malignant Solid Neoplasm
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 the...
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)...
Eligibility Criteria
Inclusion
- PRACTICE SITE: All participating practice clusters will be asked to identify one (or more) ENABLE coach as part of study eligibility to deliver the ENABLE program.
- PRACTICE SITE: Commitment of the ENABLE coach(es) to be trained to conduct the palliative care assessment (and ENABLE sessions if the practice plans to implement them).
- PRACTICE SITE: Desire to implement ENABLE, including presence of an investigator (e.g., primary affiliate principal investigator \[PI\], oncology physician, Cancer Care Delivery Research \[CCDR\] Lead) and/or program administrator/supervisor who are willing to be key contacts.
- PRACTICE SITE: Demonstrated support/buy-in from oncology physicians who are willing to enroll patients.
- PRACTICE SITE: Agreement of practice leadership and other individuals at the practice cluster to support/participate in the study activities.
- PRACTICE SITE: If necessary, willingness to participate in a phone interview to determine capacity to implement the ENABLE program.
- INDIVIDUALS AT THE PARTICIPATING PRACTICE: The ENABLE implementation team at each participating practice will include at minimum one ENABLE coach and a coordinator. Other members of the team can include the primary affiliate PI, an oncology physician or investigator, CCDR lead (if different than the coordinator, and/or the program administrator/supervisor) and other professional individuals.
- ONCOLOGY PHYSICIAN: Eligible providers at practices sites are oncology physicians (i.e., medical oncologists or radiation oncologists including trainees) caring for oncology patients. If no oncology physicians are available at the practice, other providers (e.g., advanced practice providers \[APPs\]) may take on the responsibilities of the oncology physician as laid out in this protocol. We do not require that all physicians at a practice setting agree to participate. Oncology physicians must work at a participating practice cluster with no plans to leave that practice site or retire at the time of enrollment into the study. Physicians (oncologists) may serve in the ENABLE coach role and perform the palliative care assessment, ENABLE sessions and/or monthly follow-up calls per practice discretion if they have completed appropriate training.
- ENABLE COACH: All participating practice clusters will be required to identify one (or more) ENABLE coaches as part of study eligibility to deliver the ENABLE program. The ENABLE coach is responsible for ensuring the ENABLE sessions and follow-up calls are completed per protocol specifications.
- ENABLE COACH: A registered nurse or advanced practice provider (including a nurse practitioner or physician assistant), a physician (e.g., medical and radiation oncologists, including oncology trainees), or other professionals (e.g., social workers, chaplains) with appropriate credentials and experience to deliver ENABLE
- ENABLE COACH: Individuals with an appropriate clinical license (i.e., a registered nurse, advanced practice provider, or physician, as defined above) may perform the palliative care assessment and any ENABLE sessions and follow-up calls the practice chooses to deliver
- ENABLE COACH: Other professionals (e.g., social workers, chaplains) may deliver ENABLE sessions and monthly follow-up calls for which their credentials and experience are appropriate
- ENABLE COACH: ENABLE coaches complete appropriate study training for any content delivered.
- PATIENTS: English-speaking as not all patient measures have been validated in other languages.
- PATIENTS: Age \>= 18
- PATIENTS: Willing to complete palliative care assessment and ENABLE sessions.
- PATIENTS: Diagnosed within the last 90 days with an advanced cancer (defined as a newly diagnosed stage III/IV, recurrence, or progressive solid tumor cancer). Patients can receive any cancer treatment for their advanced cancer while participating in this study.
- The 90-day interval refers to when the patient was made aware of their diagnosis.
- PATIENTS: Expected survival of at least 6 months.
- PATIENTS: Have access to telephone that can receive incoming calls.
- PATIENTS: Able to provide informed consent.
Exclusion
- PATIENTS: Received previous palliative care services. (Concurrent palliative care is allowed.)
Key Trial Info
Start Date :
July 6 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 23 2026
Estimated Enrollment :
208 Patients enrolled
Trial Details
Trial ID
NCT04062552
Start Date
July 6 2021
End Date
June 23 2026
Last Update
October 14 2025
Active Locations (113)
Enter a location and click search to find clinical trials sorted by distance.
1
Mercy Hospital Fort Smith
Fort Smith, Arkansas, United States, 72903
2
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010
3
Holy Cross Hospital
Fort Lauderdale, Florida, United States, 33308
4
Island Urology-Hilo
Hilo, Hawaii, United States, 96720