- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04062552
Learning Collaborative Vs Technical Assistance in Delivering a Palliative Care Program to Patients With Advanced Cancer
Implementing Palliative Care: Learning Collaborative vs. Technical Assistance
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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).
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Olivia Tauriello
- Phone Number: 585.275.8507
- Email: URCC_18110@URMC.Rochester.edu
Study Locations
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District of Columbia
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Washington, District of Columbia, United States, 20057
- MedStar Washington Hospital Center
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Hawaii
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Honolulu, Hawaii, United States, 96813
- Hawaii MU NCORP
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Honolulu, Hawaii, United States, 96822
- Hawaii Minority Underserved NCORP
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Iowa
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Des Moines, Iowa, United States, 50309
- Iowa-Wide Oncology Research Coalition
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Michigan
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Ann Arbor, Michigan, United States, 48106
- Michigan Cancer Research Consortium
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Missouri
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Springfield, Missouri, United States, 65804
- Cancer Research for the Ozarks NCORP (CTEP ID: AR012)
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Springfield, Missouri, United States, 65804
- Cancer Research for the Ozarks NCORP (CTEP ID: IL127)
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Springfield, Missouri, United States, 65804
- Cancer Research for the Ozarks NCORP (CTEP ID: IL148)
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Springfield, Missouri, United States, 65804
- Cancer Research for the Ozarks NCORP (CTEP ID: MO043)
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Springfield, Missouri, United States, 65804
- Cancer Research for the Ozarks NCORP (CTEP ID: MO097)
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Springfield, Missouri, United States, 65804
- Cancer Research for the Ozarks NCORP(CTEP ID: MO021)
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New York
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Lake Success, New York, United States, 11042
- Northwell Health/Center for Advanced Medicine
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Rochester, New York, United States, 14642
- University of Rochester
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North Carolina
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Winston-Salem, North Carolina, United States, 27104
- Southeast Clinical Oncology Research Consortium
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Winston-Salem, North Carolina, United States, 27104
- Roper Hospital
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Ohio
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Columbus, Ohio, United States, 43215
- Columbus NCORP
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Pennsylvania
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Danville, Pennsylvania, United States, 17822
- Geisinger Medical Center
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Danville, Pennsylvania, United States, 17822
- Geisinger Cancer Institute
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South Carolina
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Charleston, South Carolina, United States, 29401
- Bon Secours Saint Francis Hospital
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Greenville, South Carolina, United States, 29605
- Prisma Health System
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Spartanburg, South Carolina, United States, 29303
- Upstate Carolina NCORP
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Wisconsin
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Appleton, Wisconsin, United States, 54911
- ThedaCare
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Green Bay, Wisconsin, United States, 54301
- Aspirus Regional Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
Other Names:
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Experimental: Technical Assistance
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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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ENABLE Program Uptake
Time Frame: 65 weeks
|
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).
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65 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hospital Anxiety and Depression Scale (HADS)
Time Frame: Baseline, 12 weeks, 24 weeks
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Survey to measure patient mood.
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Baseline, 12 weeks, 24 weeks
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Functional Assessment of Chronic Illness-Palliative Care (FACIT-PAL)
Time Frame: Baseline, 12 weeks, 24 weeks
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Survey to measure patient quality of life.
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Baseline, 12 weeks, 24 weeks
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient mood, measured by the Hospital Anxiety and Depression Scale (HADS)
Time Frame: At 24 weeks
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This instrument assesses mood, including anxiety and depression.
Seven questions rate the depression subscale, and 7 questions rate the anxiety subscale.
Each item has a 4-point scale, ranging from 0 to 3 with possible scores ranging from 0-21 for each subscale.
Scoring for each sub-scale is as follows: 0-7 Normal, 8-10 Borderline abnormal, and 11-21 Abnormal.
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At 24 weeks
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Patient quality of life, assessed using the FACIT-Pal.
Time Frame: At 24 weeks
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The FACIT-Pal consists of the FACT-G (Functional Assessment of Cancer Therapy-General), a general measure of quality of life, and the palliative care subscale (Pal), which assesses issues specifically relevant to palliative care.
The FACT-G is a 27-item questionnaire that provides a total score as well as four subscale scores: physical, social/family, emotional, and functional wellbeing.
The FACIT-Pal includes 19 additional concerns relevant for persons at the end of life.
The total score is the sum of the FACT-G (the first 4 subscales) plus the FACIT-Pal subscale.
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At 24 weeks
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Caregiver mood, using the Hospital Anxiety and Depression Scale (HADS).
Time Frame: At 24 weeks
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This instrument assesses mood, including anxiety and depression.
Seven questions rate the depression subscale and 7 questions rate the anxiety subscale.
Each item has a 4-point scale, ranging from 0 to 3 with possible scores ranging from 0-21 for each subscale.
Scoring for each sub-scale is as follows: 0-7 Normal, 8-10 Borderline abnormal, and 11-21 Abnormal.
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At 24 weeks
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Caregiver quality of life, Measured by the Patient Reported Outcomes Measurement Information System (PROMIS) Global Health
Time Frame: At 24 weeks
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The 10-item PROMIS Global Health measure uses Likert-scale response options for each item, ranging from 1 (always) to 5 (never).
This instrument produces 2 scores: physical health and mental health score; we will use the the mental health score for MOOD and the total summary score for quality of life (QOL).
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At 24 weeks
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Collaborators and Investigators
Investigators
- Principal Investigator: Lisa Zubkoff, PhD, University of Alabama at Birmingham
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- URCC18110CD (Other Identifier: University of Rochester NCORP Research Base)
- UG1CA189961 (U.S. NIH Grant/Contract)
- NCI-2019-02246 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- URCC-18110CD (Other Identifier: CTEP)
- R01CA229197 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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