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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2019-02246 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| URCC18110CD_ | |||
| URCC18110CD | Other Identifier | University of Rochester NCORP Research Base | |
| URCC-18110CD | Other Identifier | DCP | |
| URCC-18110CD | Other Identifier | CTEP | |
| R01CA229197 | U.S. NIH Grant/Contract | View source | |
| UG1CA189961 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral, Psychological or Informational Intervention | Other | Receive ENABLE palliative care information |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Preliminary effectiveness of VLC or TA on patient quality of life and mood outcomes | Will examine and quantify study group differences. A primary analysis, including all patients (either deceased or surviving by the scheduled 24-week follow-up) will be conducted using joint-modeling for longitudinal and time-to-event data to obtain inferences on the longitudinal outcome corrected for non-ignorable missing data due to death. In this approach, submodels for both the longitudinal process and the time-to-event process are estimated simultaneously, with a Cox model for the survival submodel, and a linear mixed-effects model for the longitudinal submodel. The two submodels share random effects for each individual, and these random effects account for both the association between the longitudinal outcome and the risk of death. A sensitivity analysis will also be performed. |
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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.
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:
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| Name | Affiliation | Role |
|---|---|---|
| Lisa Zubkoff, PhD | University of Rochester NCORP Research Base | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mercy Hospital Fort Smith | Fort Smith | Arkansas | 72903 | United States | ||
| MedStar Washington Hospital Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41761561 | Derived | Zubkoff L, Carpenter-Song E, Lyons KD, Odom JN, Khalidi S, Azuero A, Flannery M, Taylor R, Richards J, Mustian K, Wells M, Hancock J, Wojtowicz M, Weiss M, Mohile S, Bakitas MA. A process evaluation of early palliative care implementation in the National Cancer Institute Community Oncology Research Program. JNCI Cancer Spectr. 2026 Mar 3;10(2):pkag018. doi: 10.1093/jncics/pkag018. | |
| 33706770 | Derived | 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. |
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| Educational Intervention | Other | Participate in VLC group-based learning sessions |
|
|
| Educational Intervention | Other | Participate in consultation with ENABLE/TA expert |
|
|
| Medical Examination Assessment | Procedure | Undergo palliative care assessment |
|
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| Quality-of-Life Assessment | Other | Ancillary studies |
|
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| Survey Administration | Other | Complete surveys |
|
| Telephone-Based Intervention | Behavioral | Receive monthly phone calls |
|
| At 24 weeks |
| Relationship between ENABLE program uptake and patient outcomes | Will estimate the relationship between change in patient outcomes (quality of life and mood) using the number of ENABLE sessions completed (ENABLE program uptake) as the main predictor. The crude association between ENABLE sessions and change in patient outcomes will be examined graphically with profile plots, and with linear mixed models to determine whether the relationship is better fitted by a linear, a more complex trend, or as ordinal categorical data. Since the number of ENABLE sessions completed might be dependent on patient characteristics (e.g., sex, illness acuity, age), a covariate adjustment (via an adjusting score) will be conducted on the crude association estimate to determine the change in outcomes attributable to the number of ENABLE sessions completed, above and beyond patient characteristics. The adjusting score will be estimated with a random forest ensemble, based on patient characteristics. | Up to 24 weeks |
| Washington D.C. |
| District of Columbia |
| 20010 |
| United States |
| Holy Cross Hospital | Fort Lauderdale | Florida | 33308 | United States |
| Island Urology-Hilo | Hilo | Hawaii | 96720 | United States |
| Hawaii Cancer Care Inc - Waterfront Plaza | Honolulu | Hawaii | 96813 | United States |
| Island Urology | Honolulu | Hawaii | 96813 | United States |
| Queen's Cancer Cenrer - POB I | Honolulu | Hawaii | 96813 | United States |
| Queen's Medical Center | Honolulu | Hawaii | 96813 | United States |
| Straub Clinic and Hospital | Honolulu | Hawaii | 96813 | United States |
| University of Hawaii Cancer Center | Honolulu | Hawaii | 96813 | United States |
| Hawaii Cancer Care Inc-Liliha | Honolulu | Hawaii | 96817 | United States |
| Kuakini Medical Center | Honolulu | Hawaii | 96817 | United States |
| Queen's Cancer Center - Kuakini | Honolulu | Hawaii | 96817 | United States |
| The Cancer Center of Hawaii-Liliha | Honolulu | Hawaii | 96817 | United States |
| Kapiolani Medical Center for Women and Children | Honolulu | Hawaii | 96826 | United States |
| Wilcox Memorial Hospital and Kauai Medical Clinic | Lihue | Hawaii | 96766 | United States |
| Hawaii Cancer Care - Westridge | ‘Aiea | Hawaii | 96701 | United States |
| Pali Momi Medical Center | ‘Aiea | Hawaii | 96701 | United States |
| Queen's Cancer Center - Pearlridge | ‘Aiea | Hawaii | 96701 | United States |
| The Cancer Center of Hawaii-Pali Momi | ‘Aiea | Hawaii | 96701 | United States |
| Saint Mary's Hospital | Centralia | Illinois | 62801 | United States |
| SSM Health Good Samaritan | Mount Vernon | Illinois | 62864 | United States |
| Mercy Medical Center - Des Moines | Des Moines | Iowa | 50314 | United States |
| Mercy Medical Center | Springfield | Massachusetts | 01104 | United States |
| Trinity Health Saint Joseph Mercy Hospital Ann Arbor | Ann Arbor | Michigan | 48106 | United States |
| Trinity Health IHA Medical Group Hematology Oncology - Brighton | Brighton | Michigan | 48114 | United States |
| Trinity Health Medical Center - Brighton | Brighton | Michigan | 48114 | United States |
| Trinity Health IHA Medical Group Hematology Oncology - Canton | Canton | Michigan | 48188 | United States |
| Trinity Health Medical Center - Canton | Canton | Michigan | 48188 | United States |
| Caro Cancer Center | Caro | Michigan | 48723 | United States |
| Chelsea Hospital | Chelsea | Michigan | 48118 | United States |
| Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital | Chelsea | Michigan | 48118 | United States |
| Hematology Oncology Consultants-Clarkston | Clarkston | Michigan | 48346 | United States |
| Newland Medical Associates-Clarkston | Clarkston | Michigan | 48346 | United States |
| Henry Ford Health Saint John Hospital | Detroit | Michigan | 48236 | United States |
| Henry Ford River District Hospital | East China | Michigan | 48054 | United States |
| Cancer Hematology Centers - Flint | Flint | Michigan | 48503 | United States |
| Genesee Hematology Oncology PC | Flint | Michigan | 48503 | United States |
| Genesys Hurley Cancer Institute | Flint | Michigan | 48503 | United States |
| Hurley Medical Center | Flint | Michigan | 48503 | United States |
| Henry Ford Saint John Hospital - Academic | Grosse Pointe Woods | Michigan | 48236 | United States |
| Henry Ford Saint John Hospital - Breast | Grosse Pointe Woods | Michigan | 48236 | United States |
| Henry Ford Saint John Hospital - Van Elslander | Grosse Pointe Woods | Michigan | 48236 | United States |
| University of Michigan Health - Sparrow Lansing | Lansing | Michigan | 48912 | United States |
| Hope Cancer Clinic | Livonia | Michigan | 48154 | United States |
| Trinity Health Saint Mary Mercy Livonia Hospital | Livonia | Michigan | 48154 | United States |
| Henry Ford Saint John Hospital - Macomb Medical | Macomb | Michigan | 48044 | United States |
| Henry Ford Warren Hospital - Breast Macomb | Macomb | Michigan | 48044 | United States |
| Saint Mary's Oncology/Hematology Associates of Marlette | Marlette | Michigan | 48453 | United States |
| Hope Cancer Center | Pontiac | Michigan | 48341 | United States |
| Michigan Healthcare Professionals Pontiac | Pontiac | Michigan | 48341 | United States |
| Newland Medical Associates-Pontiac | Pontiac | Michigan | 48341 | United States |
| Trinity Health Saint Joseph Mercy Oakland Hospital | Pontiac | Michigan | 48341 | United States |
| Henry Ford Rochester Hospital | Rochester Hills | Michigan | 48309 | United States |
| MyMichigan Medical Center Saginaw | Saginaw | Michigan | 48601 | United States |
| Oncology Hematology Associates of Saginaw Valley PC | Saginaw | Michigan | 48604 | United States |
| Bhadresh Nayak MD PC-Sterling Heights | Sterling Heights | Michigan | 48312 | United States |
| MyMichigan Medical Center Tawas | Tawas City | Michigan | 48764 | United States |
| Advanced Breast Care Center PLLC | Warren | Michigan | 48088 | United States |
| Henry Ford Health Warren Hospital | Warren | Michigan | 48093 | United States |
| Henry Ford Madison Heights Hospital - Breast | Warren | Michigan | 48093 | United States |
| Henry Ford Warren Hospital - GLCMS | Warren | Michigan | 48093 | United States |
| Macomb Hematology Oncology PC | Warren | Michigan | 48093 | United States |
| Saint Mary's Oncology/Hematology Associates of West Branch | West Branch | Michigan | 48661 | United States |
| Huron Gastroenterology PC | Ypsilanti | Michigan | 48106 | United States |
| Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus | Ypsilanti | Michigan | 48197 | United States |
| Mercy Clinic-Rolla-Cancer and Hematology | Rolla | Missouri | 65401 | United States |
| Mercy Hospital Springfield | Springfield | Missouri | 65804 | United States |
| Mercy Hospital South | St Louis | Missouri | 63128 | United States |
| Mercy Hospital Saint Louis | St Louis | Missouri | 63141 | United States |
| Northwell Health/Center for Advanced Medicine | Lake Success | New York | 11042 | United States |
| Strecker Cancer Center-Belpre | Belpre | Ohio | 45714 | United States |
| Adena Regional Medical Center | Chillicothe | Ohio | 45601 | United States |
| Mount Carmel East Hospital | Columbus | Ohio | 43213 | United States |
| Columbus Oncology and Hematology Associates Inc | Columbus | Ohio | 43214 | United States |
| Riverside Methodist Hospital | Columbus | Ohio | 43214 | United States |
| Grant Medical Center | Columbus | Ohio | 43215 | United States |
| The Mark H Zangmeister Center | Columbus | Ohio | 43219 | United States |
| Mount Carmel Health Center West | Columbus | Ohio | 43222 | United States |
| Doctors Hospital | Columbus | Ohio | 43228 | United States |
| Delaware Health Center-Grady Cancer Center | Delaware | Ohio | 43015 | United States |
| Grady Memorial Hospital | Delaware | Ohio | 43015 | United States |
| Dublin Methodist Hospital | Dublin | Ohio | 43016 | United States |
| Central Ohio Breast and Endocrine Surgery | Gahanna | Ohio | 43230 | United States |
| Mount Carmel Grove City Hospital | Grove City | Ohio | 43123 | United States |
| Fairfield Medical Center | Lancaster | Ohio | 43130 | United States |
| OhioHealth Mansfield Hospital | Mansfield | Ohio | 44903 | United States |
| Marietta Memorial Hospital | Marietta | Ohio | 45750 | United States |
| OhioHealth Marion General Hospital | Marion | Ohio | 43302 | United States |
| Knox Community Hospital | Mount Vernon | Ohio | 43050 | United States |
| Licking Memorial Hospital | Newark | Ohio | 43055 | United States |
| Newark Radiation Oncology | Newark | Ohio | 43055 | United States |
| Southern Ohio Medical Center | Portsmouth | Ohio | 45662 | United States |
| Saint Ann's Hospital | Westerville | Ohio | 43081 | United States |
| Genesis Healthcare System Cancer Care Center | Zanesville | Ohio | 43701 | United States |
| Lehigh Valley Hospital-Cedar Crest | Allentown | Pennsylvania | 18103 | United States |
| Lehigh Valley Hospital - Muhlenberg | Bethlehem | Pennsylvania | 18017 | United States |
| Geisinger Medical Center | Danville | Pennsylvania | 17822 | United States |
| Pocono Medical Center | East Stroudsburg | Pennsylvania | 18301 | United States |
| Lehigh Valley Hospital-Hazleton | Hazleton | Pennsylvania | 18201 | United States |
| Roper Hospital | Charleston | South Carolina | 29401 | United States |
| Bon Secours Saint Francis Hospital | Charleston | South Carolina | 29414 | United States |
| McLeod Regional Medical Center | Florence | South Carolina | 29506 | United States |
| Gibbs Cancer Center-Gaffney | Gaffney | South Carolina | 29341 | United States |
| Prisma Health Greenville Memorial Hospital | Greenville | South Carolina | 29605 | United States |
| Prisma Health Cancer Institute - Eastside | Greenville | South Carolina | 29615 | United States |
| Gibbs Cancer Center-Pelham | Greer | South Carolina | 29651 | United States |
| Spartanburg Medical Center | Spartanburg | South Carolina | 29303 | United States |
| SMC Center for Hematology Oncology Union | Union | South Carolina | 29379 | United States |
| ThedaCare Regional Cancer Center | Appleton | Wisconsin | 54911 | United States |
| ThedaCare Regional Medical Center - Neenah | Neenah | Wisconsin | 54956 | United States |
| ThedaCare Cancer Care - Shawano | Shawano | Wisconsin | 54166 | United States |
| Aspirus Regional Cancer Center | Wausau | Wisconsin | 54401 | United States |
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D018479 | Early Intervention, Educational |
| D004522 | Educational Status |
| D008722 | Methods |
| D012149 | Restraint, Physical |
| D009749 | Nutrition Surveys |
| D000070536 | Independent Medical Evaluation |
| ID | Term |
|---|---|
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D011314 | Preventive Health Services |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
| D008919 | Investigative Techniques |
| D032763 | Behavior Control |
| D013812 | Therapeutics |
| D007103 | Immobilization |
| D011795 | Surveys and Questionnaires |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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