Clinical trial NCT04062552: Learning Collaborative Versus Technical Assistance in Delivering a Palliative Care Program to Patients With Advanced Cancer and Their Caregivers
Official title: Implementing Palliative Care: Learning Collaborative vs. Technical Assistance
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Advanced Malignant Solid Neoplasm
Metastatic Malignant Solid Neoplasm
Recurrent Malignant Solid Neoplasm
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-08-20
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

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

Primary outcomes:
measure: Patient completion of the Educate, Nurture, Advise, Before Life Ends (ENABLE) program
timeFrame: Up to 24 weeks
Secondary outcomes:
measure: Preliminary effectiveness of VLC or TA on patient quality of life and mood outcomes
timeFrame: At 24 weeks
measure: Relationship between ENABLE program uptake and patient outcomes
timeFrame: Up to 24 weeks
Other outcomes:
Locations:
city: Ft. Smith
country: United States
facility: Mercy Hospital Fort Smith
state: Arkansas
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
city: Fort Lauderdale
country: United States
facility: Holy Cross Hospital
state: Florida
city: Aiea
country: United States
facility: Hawaii Cancer Care - Westridge
state: Hawaii
city: Aiea
country: United States
facility: Pali Momi Medical Center
state: Hawaii
city: Aiea
country: United States
facility: Queen's Cancer Center - Pearlridge
state: Hawaii
city: Aiea
country: United States
facility: The Cancer Center of Hawaii-Pali Momi
state: Hawaii
city: Hilo
country: United States
facility: Island Urology-Hilo
state: Hawaii
city: Honolulu
country: United States
facility: Hawaii Cancer Care Inc - Waterfront Plaza
state: Hawaii
city: Honolulu
country: United States
facility: Island Urology
state: Hawaii
city: Honolulu
country: United States
facility: Queen's Cancer Cenrer - POB I
state: Hawaii
city: Honolulu
country: United States
facility: Queen's Medical Center
state: Hawaii
city: Honolulu
country: United States
facility: Straub Clinic and Hospital
state: Hawaii
city: Honolulu
country: United States
facility: University of Hawaii Cancer Center
state: Hawaii
city: Honolulu
country: United States
facility: Hawaii Cancer Care Inc-Liliha
state: Hawaii
city: Honolulu
country: United States
facility: Kuakini Medical Center
state: Hawaii
city: Honolulu
country: United States
facility: Queen's Cancer Center - Kuakini
state: Hawaii
city: Honolulu
country: United States
facility: The Cancer Center of Hawaii-Liliha
state: Hawaii
city: Honolulu
country: United States
facility: Kapiolani Medical Center for Women and Children
state: Hawaii
city: Lihue
country: United States
facility: Wilcox Memorial Hospital and Kauai Medical Clinic
state: Hawaii
city: Centralia
country: United States
facility: Saint Mary's Hospital
state: Illinois
city: Mount Vernon
country: United States
facility: SSM Health Good Samaritan
state: Illinois
city: Des Moines
country: United States
facility: Mercy Medical Center - Des Moines
state: Iowa
city: Springfield
country: United States
facility: Mercy Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: Trinity Health Saint Joseph Mercy Hospital Ann Arbor
state: Michigan
city: Brighton
country: United States
facility: Trinity Health IHA Medical Group Hematology Oncology - Brighton
state: Michigan
city: Brighton
country: United States
facility: Trinity Health Medical Center - Brighton
state: Michigan
city: Canton
country: United States
facility: Trinity Health IHA Medical Group Hematology Oncology - Canton
state: Michigan
city: Canton
country: United States
facility: Trinity Health Medical Center - Canton
state: Michigan
city: Caro
country: United States
facility: Caro Cancer Center
state: Michigan
city: Chelsea
country: United States
facility: Chelsea Hospital
state: Michigan
city: Chelsea
country: United States
facility: Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
state: Michigan
city: Clarkston
country: United States
facility: Hematology Oncology Consultants-Clarkston
state: Michigan
city: Clarkston
country: United States
facility: Newland Medical Associates-Clarkston
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health Saint John Hospital
state: Michigan
city: East China
country: United States
facility: Henry Ford River District Hospital
state: Michigan
city: Flint
country: United States
facility: Cancer Hematology Centers - Flint
state: Michigan
city: Flint
country: United States
facility: Genesee Hematology Oncology PC
state: Michigan
city: Flint
country: United States
facility: Genesys Hurley Cancer Institute
state: Michigan
city: Flint
country: United States
facility: Hurley Medical Center
state: Michigan
city: Grosse Pointe Woods
country: United States
facility: Henry Ford Saint John Hospital - Academic
state: Michigan
city: Grosse Pointe Woods
country: United States
facility: Henry Ford Saint John Hospital - Breast
state: Michigan
city: Grosse Pointe Woods
country: United States
facility: Henry Ford Saint John Hospital - Van Elslander
state: Michigan
city: Lansing
country: United States
facility: University of Michigan Health - Sparrow Lansing
state: Michigan
city: Livonia
country: United States
facility: Hope Cancer Clinic
state: Michigan
city: Livonia
country: United States
facility: Trinity Health Saint Mary Mercy Livonia Hospital
state: Michigan
city: Macomb Township
country: United States
facility: Henry Ford Saint John Hospital - Macomb Medical
state: Michigan
city: Macomb Township
country: United States
facility: Henry Ford Warren Hospital - Breast Macomb
state: Michigan
city: Marlette
country: United States
facility: Saint Mary's Oncology/Hematology Associates of Marlette
state: Michigan
city: Pontiac
country: United States
facility: Hope Cancer Center
state: Michigan
city: Pontiac
country: United States
facility: Michigan Healthcare Professionals Pontiac
state: Michigan
city: Pontiac
country: United States
facility: Newland Medical Associates-Pontiac
state: Michigan
city: Pontiac
country: United States
facility: Trinity Health Saint Joseph Mercy Oakland Hospital
state: Michigan
city: Rochester Hills
country: United States
facility: Henry Ford Rochester Hospital
state: Michigan
city: Saginaw
country: United States
facility: MyMichigan Medical Center Saginaw
state: Michigan
city: Saginaw
country: United States
facility: Oncology Hematology Associates of Saginaw Valley PC
state: Michigan
city: Sterling Heights
country: United States
facility: Bhadresh Nayak MD PC-Sterling Heights
state: Michigan
city: Tawas City
country: United States
facility: MyMichigan Medical Center Tawas
state: Michigan
city: Warren
country: United States
facility: Advanced Breast Care Center PLLC
state: Michigan
city: Warren
country: United States
facility: Henry Ford Health Warren Hospital
state: Michigan
city: Warren
country: United States
facility: Henry Ford Madison Heights Hospital - Breast
state: Michigan
city: Warren
country: United States
facility: Henry Ford Warren Hospital - GLCMS
state: Michigan
city: Warren
country: United States
facility: Macomb Hematology Oncology PC
state: Michigan
city: West Branch
country: United States
facility: Saint Mary's Oncology/Hematology Associates of West Branch
state: Michigan
city: Ypsilanti
country: United States
facility: Huron Gastroenterology PC
state: Michigan
city: Ypsilanti
country: United States
facility: Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
state: Michigan
city: Rolla
country: United States
facility: Mercy Clinic-Rolla-Cancer and Hematology
state: Missouri
city: Saint Louis
country: United States
facility: Mercy Hospital South
state: Missouri
city: Saint Louis
country: United States
facility: Mercy Hospital Saint Louis
state: Missouri
city: Springfield
country: United States
facility: Mercy Hospital Springfield
state: Missouri
city: Lake Success
country: United States
facility: Northwell Health/Center for Advanced Medicine
state: New York
city: Belpre
country: United States
facility: Strecker Cancer Center-Belpre
state: Ohio
city: Chillicothe
country: United States
facility: Adena Regional Medical Center
state: Ohio
city: Columbus
country: United States
facility: Mount Carmel East Hospital
state: Ohio
city: Columbus
country: United States
facility: Columbus Oncology and Hematology Associates Inc
state: Ohio
city: Columbus
country: United States
facility: Riverside Methodist Hospital
state: Ohio
city: Columbus
country: United States
facility: Grant Medical Center
state: Ohio
city: Columbus
country: United States
facility: The Mark H Zangmeister Center
state: Ohio
city: Columbus
country: United States
facility: Mount Carmel Health Center West
state: Ohio
city: Columbus
country: United States
facility: Doctors Hospital
state: Ohio
city: Delaware
country: United States
facility: Delaware Health Center-Grady Cancer Center
state: Ohio
city: Delaware
country: United States
facility: Grady Memorial Hospital
state: Ohio
city: Dublin
country: United States
facility: Dublin Methodist Hospital
state: Ohio
city: Gahanna
country: United States
facility: Central Ohio Breast and Endocrine Surgery
state: Ohio
city: Grove City
country: United States
facility: Mount Carmel Grove City Hospital
state: Ohio
city: Lancaster
country: United States
facility: Fairfield Medical Center
state: Ohio
city: Mansfield
country: United States
facility: OhioHealth Mansfield Hospital
state: Ohio
city: Marietta
country: United States
facility: Marietta Memorial Hospital
state: Ohio
city: Marion
country: United States
facility: OhioHealth Marion General Hospital
state: Ohio
city: Mount Vernon
country: United States
facility: Knox Community Hospital
state: Ohio
city: Newark
country: United States
facility: Licking Memorial Hospital
state: Ohio
city: Newark
country: United States
facility: Newark Radiation Oncology
state: Ohio
city: Portsmouth
country: United States
facility: Southern Ohio Medical Center
state: Ohio
city: Westerville
country: United States
facility: Saint Ann's Hospital
state: Ohio
city: Zanesville
country: United States
facility: Genesis Healthcare System Cancer Care Center
state: Ohio
city: Allentown
country: United States
facility: Lehigh Valley Hospital-Cedar Crest
state: Pennsylvania
city: Bethlehem
country: United States
facility: Lehigh Valley Hospital - Muhlenberg
state: Pennsylvania
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: East Stroudsburg
country: United States
facility: Pocono Medical Center
state: Pennsylvania
city: Hazleton
country: United States
facility: Lehigh Valley Hospital-Hazleton
state: Pennsylvania
city: Charleston
country: United States
facility: Roper Hospital
state: South Carolina
city: Charleston
country: United States
facility: Bon Secours Saint Francis Hospital
state: South Carolina
city: Florence
country: United States
facility: McLeod Regional Medical Center
state: South Carolina
city: Gaffney
country: United States
facility: Gibbs Cancer Center-Gaffney
state: South Carolina
city: Greenville
country: United States
facility: Prisma Health Greenville Memorial Hospital
state: South Carolina
city: Greenville
country: United States
facility: Prisma Health Cancer Institute - Eastside
state: South Carolina
city: Greer
country: United States
facility: Gibbs Cancer Center-Pelham
state: South Carolina
city: Spartanburg
country: United States
facility: Spartanburg Medical Center
state: South Carolina
city: Union
country: United States
facility: SMC Center for Hematology Oncology Union
state: South Carolina
city: Appleton
country: United States
facility: ThedaCare Regional Cancer Center
state: Wisconsin
city: Neenah
country: United States
facility: ThedaCare Regional Medical Center - Neenah
state: Wisconsin
city: Shawano
country: United States
facility: ThedaCare Cancer Care - Shawano
state: Wisconsin
city: Wausau
country: United States
facility: Aspirus Regional Cancer Center
state: Wisconsin
Study officials:
affiliation: University of Rochester NCORP Research Base
name: Lisa Zubkoff, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zubkoff L, Lyons KD, Dionne-Odom JN, Hagley G, Pisu M, Azuero A, Flannery M, Taylor R, Carpenter-Song E, Mohile S, Bakitas MA. A cluster randomized controlled trial comparing Virtual Learning Collaborative and Technical Assistance strategies to implement an early palliative care program for patients with advanced cancer and their caregivers: a study protocol. Implement Sci. 2021 Mar 11;16(1):25. doi: 10.1186/s13012-021-01086-3.