NCT04062552|Active Not RecruitingDMC

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

University of Rochester NCORP Research Base ClinicalTrials.gov

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6 other identifiers

URCC18110CDNCI-2019-02246URCC18110CD_URCC-18110CDR01CA229197UG1CA189961

Study Type

interventional

Target

208

Locations

1 country

Sites

113

Timeline

RegisteredAug 2019

StartedMar 2021

CompletionAug 2026

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 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

208

participants targeted

Target at P75+ for not_applicable

Timeline

3mo left

Started Mar 2021

Longer than P75 for not_applicable

Geographic Reach

1 country

113 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

5.5 years study duration

Study Progress95%

Mar 2021Aug 2026

First Submitted

Initial submission to the registry

August 12, 2019

Completed

8 days until next milestone

First Posted

Study publicly available on registry

August 20, 2019

Completed

1.6 years until next milestone

Study Start

First participant enrolled

March 9, 2021

Completed

4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 16, 2025

Completed

11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 23, 2026

Expected

Last Updated

January 13, 2026

Status Verified

January 1, 2026

Enrollment Period

4.5 years

First QC Date

August 12, 2019

Last Update Submit

January 10, 2026

Conditions

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

Outcome Measures

Primary Outcomes (1)

Patient completion of the Educate, Nurture, Advise, Before Life Ends (ENABLE) program
Defined as having a palliative care assessment and completing at least 4 ENABLE sessions. A logit generalized estimating equation model with exchangeable correlation structure (to account for clustering within practice) will be fitted to a binary patient uptake indicator ("yes" if the patient completed a palliative care assessment and at least 4 ENABLE program sessions and "no" if the patient does not), with the group assignment as the main predictor. Model-predicted uptake proportions, odds ratios, relative risks, and confidence intervals for these measures will be used for interpretation. An additional analysis with sex, group assignment, and an interaction between the two as predictors will be conducted to examine whether this biological variable is a possible moderator of ENABLE program uptake.
Up to 24 weeks

Secondary Outcomes (2)

Preliminary effectiveness of VLC or TA on patient quality of life and mood outcomes
At 24 weeks
Relationship between ENABLE program uptake and patient outcomes
Up to 24 weeks

Study Arms (2)

Group I (ENABLE palliative care program, phone calls, VLC)

EXPERIMENTAL

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 VLC consisting of group-based learning sessions, coaching, and applied quality improvement data collection, analysis and feedback opportunities monthly for 15 months.

Other: Behavioral, Psychological or Informational InterventionOther: Educational InterventionProcedure: Medical Examination AssessmentOther: Quality-of-Life AssessmentOther: Survey AdministrationBehavioral: Telephone-Based Intervention

Group II (ENABLE palliative care program, phone calls, TA)

EXPERIMENTAL

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/TA expert monthly for 15 months.

Interventions

Behavioral, Psychological or Informational InterventionOTHER

Receive ENABLE palliative care information

Group I (ENABLE palliative care program, phone calls, VLC)Group II (ENABLE palliative care program, phone calls, TA)

Medical Examination AssessmentPROCEDURE

Undergo palliative care assessment

Also known as: Exam, Examination, Health Assessment, Health Examination, Health Status Assessment, Medical Assessment, Medical Exam, Medical Inspection

Group I (ENABLE palliative care program, phone calls, VLC)Group II (ENABLE palliative care program, phone calls, TA)

Telephone-Based InterventionBEHAVIORAL

Receive monthly phone calls

Group I (ENABLE palliative care program, phone calls, VLC)Group II (ENABLE palliative care program, phone calls, TA)

Educational InterventionOTHER

Participate in VLC group-based learning sessions

Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Group I (ENABLE palliative care program, phone calls, VLC)

Quality-of-Life AssessmentOTHER

Ancillary studies

Also known as: Quality of Life Assessment

Group I (ENABLE palliative care program, phone calls, VLC)Group II (ENABLE palliative care program, phone calls, TA)

Survey AdministrationOTHER

Complete surveys

Group I (ENABLE palliative care program, phone calls, VLC)Group II (ENABLE palliative care program, phone calls, TA)

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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
+6 more criteria

You may not qualify if:

PATIENTS: Received previous palliative care services. (Concurrent palliative care is allowed.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

National Cancer Institute (NCI)collaborator
University of Rochester NCORP Research Baselead

Study Sites (113)

Mercy Hospital Fort Smith

Fort Smith, Arkansas, 72903, United States

Location

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Holy Cross Hospital

Fort Lauderdale, Florida, 33308, United States

Location

Island Urology-Hilo

Hilo, Hawaii, 96720, United States

Location

Hawaii Cancer Care Inc - Waterfront Plaza