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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04062552
• Other study ID #: URCC18110CD
• Secondary ID: NCI-2019-02246UR
• Status: Enrolling by invitation
• Phase: N/A
• Start date: July 6, 2021
• Est. completion date: September 30, 2025

Study information

• Verified date: December 2023
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 208
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

PATIENTS

Inclusion Criteria:

• Age = 18
• English-speaking
• Willing to complete palliative care assessment and ENABLE sessions.
• 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.
• Expected survival of at least 6 months
• Have access to telephone that can receive incoming calls.
• Able to provide informed consent.

Exclusion Criteria:

• Received previous palliative care services (Concurrent palliative care is allowed). PRACTICE SITES

Inclusion Criteria:

• All participating practice clusters will be asked to identify one (or more) ENABLE Coaches as part of study eligibility to deliver the ENABLE program.
• 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).
• Desire to implement ENABLE, including presence of an investigator (e.g., Primary Affiliate PI, oncology physician, CCDR Lead) and/or program administrator/supervisor who are willing to be key contacts.
• Demonstrated support/buy-in from oncology physicians who are willing to enroll patients.
• Agreement of practice leadership and other individuals at the practice cluster to support/participate in the study activities
• If necessary, willingness to participate in a phone interview to determine capacity to implement the ENABLE program. ONCOLOGY PHYSICIAN

Inclusion Criteria:

• Oncology Physician (i.e., medical oncologist or radiation oncologist including trainees) caring for oncology patients.
• 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. ENABLE COACH

Inclusion Criteria:

• 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.
• 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.
• 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 Coaches are required to complete appropriate study training for any content delivered.

Related Conditions & MeSH terms

• Advanced Solid Tumor

Intervention

Behavioral:
• Virtual Learning Collaborative
Patients undergo a palliative care assessment, participate in up to 6 ENABLE telehealth sessions with an ENABLE coach (20-45 minutes each), and complete up to 6 monthly follow-up calls over a 26-week period. The practice sites participate in a VLC consisting of group-based learning sessions, coaching, and applied quality improvement data collection, analysis and feedback opportunities monthly for up to 15 months.
• Technical Assistance
Patients undergo a palliative care assessment, participate in up to 6 ENABLE telehealth sessions with an ENABLE coach (20-45 minutes each), and complete up to 6 monthly follow-up calls over a 26-week period. The practice sites undergo practice-based consultation calls with an ENABLE/TA expert monthly for up to 15 months.

Locations

Country	Name	City	State
United States	Michigan Cancer Research Consortium	Ann Arbor	Michigan
United States	ThedaCare	Appleton	Wisconsin
United States	Bon Secours Saint Francis Hospital	Charleston	South Carolina
United States	Columbus NCORP	Columbus	Ohio
United States	Geisinger Cancer Institute	Danville	Pennsylvania
United States	Geisinger Medical Center	Danville	Pennsylvania
United States	Iowa-Wide Oncology Research Coalition	Des Moines	Iowa
United States	Aspirus Regional Cancer Center	Green Bay	Wisconsin
United States	Prisma Health System	Greenville	South Carolina
United States	Hawaii Minority Underserved NCORP	Honolulu	Hawaii
United States	Hawaii MU NCORP	Honolulu	Hawaii
United States	Northwell Health/Center for Advanced Medicine	Lake Success	New York
United States	University of Rochester	Rochester	New York
United States	Upstate Carolina NCORP	Spartanburg	South Carolina
United States	Cancer Research for the Ozarks NCORP (CTEP ID: AR012)	Springfield	Missouri
United States	Cancer Research for the Ozarks NCORP (CTEP ID: IL127)	Springfield	Missouri
United States	Cancer Research for the Ozarks NCORP (CTEP ID: IL148)	Springfield	Missouri
United States	Cancer Research for the Ozarks NCORP (CTEP ID: MO043)	Springfield	Missouri
United States	Cancer Research for the Ozarks NCORP (CTEP ID: MO097)	Springfield	Missouri
United States	Cancer Research for the Ozarks NCORP(CTEP ID: MO021)	Springfield	Missouri
United States	MedStar Washington Hospital Center	Washington	District of Columbia
United States	Roper Hospital	Winston-Salem	North Carolina
United States	Southeast Clinical Oncology Research Consortium	Winston-Salem	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
University of Rochester NCORP Research Base	National Cancer Institute (NCI), University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ENABLE Program Uptake	ENABLE program uptake is defined as the proportion of enrolled patients at participating NCORP practices that complete a Palliative Care Assessment and at least 4 ENABLE sessions. To capture ENABLE program uptake, participating practices will use standardized logs to capture individuals offered the program, enrollment, and completion of the essential ENABLE elements (i.e., palliative care assessment, ENABLE telehealth sessions, follow-up calls).	65 weeks
Secondary	Hospital Anxiety and Depression Scale (HADS)	Survey to measure patient mood.	Baseline, 12 weeks, 24 weeks
Secondary	Functional Assessment of Chronic Illness-Palliative Care (FACIT-PAL)	Survey to measure patient quality of life.	Baseline, 12 weeks, 24 weeks