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Advanced Malignant Solid NeoplasmNCT04062552

Learning Collaborative Versus Technical Assistance in Delivering a Palliative Care Program to Patients With Advanced Cancer and Their Caregivers

A study testing Behavioral, Psychological or Informational Intervention, Educational Intervention and Medical Examination Assessment in people with Advanced Malignant Solid Neoplasm and Metastatic Malignant Solid Neoplasm, run by University of Rochester NCORP Research Base at 113 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Behavioral, Psychological or Informational Intervention, Educational Intervention and Medical Examination Assessment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
208 participants
Where
113 sitesUnited States
Study dates
9 Mar 2021to 23 Aug 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 21Show fewer
  • 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.

Who cannot join

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

Trial locations and contacts

113 sites in 1 country.

113 sites in 1 country

United States113 sites

  • Hawaii Cancer Care - Westridge

    ‘Aiea, Hawaii, 96701

  • Pali Momi Medical Center

    ‘Aiea, Hawaii, 96701

  • Queen's Cancer Center - Pearlridge

    ‘Aiea, Hawaii, 96701

  • The Cancer Center of Hawaii-Pali Momi

    ‘Aiea, Hawaii, 96701

  • Lehigh Valley Hospital-Cedar Crest

    Allentown, Pennsylvania, 18103

  • Trinity Health Saint Joseph Mercy Hospital Ann Arbor

    Ann Arbor, Michigan, 48106

  • ThedaCare Regional Cancer Center

    Appleton, Wisconsin, 54911

  • Strecker Cancer Center-Belpre

    Belpre, Ohio, 45714

  • Lehigh Valley Hospital - Muhlenberg

    Bethlehem, Pennsylvania, 18017

  • Trinity Health IHA Medical Group Hematology Oncology - Brighton

    Brighton, Michigan, 48114

  • Trinity Health Medical Center - Brighton

    Brighton, Michigan, 48114

  • Trinity Health IHA Medical Group Hematology Oncology - Canton

    Canton, Michigan, 48188

  • Trinity Health Medical Center - Canton

    Canton, Michigan, 48188

  • Caro Cancer Center

    Caro, Michigan, 48723

  • Saint Mary's Hospital

    Centralia, Illinois, 62801

  • Roper Hospital

    Charleston, South Carolina, 29401

  • Bon Secours Saint Francis Hospital

    Charleston, South Carolina, 29414

  • Chelsea Hospital

    Chelsea, Michigan, 48118

  • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

    Chelsea, Michigan, 48118

  • Adena Regional Medical Center

    Chillicothe, Ohio, 45601

  • Hematology Oncology Consultants-Clarkston

    Clarkston, Michigan, 48346

  • Newland Medical Associates-Clarkston

    Clarkston, Michigan, 48346

  • Mount Carmel East Hospital

    Columbus, Ohio, 43213

  • Columbus Oncology and Hematology Associates Inc

    Columbus, Ohio, 43214

  • Riverside Methodist Hospital

    Columbus, Ohio, 43214

  • Grant Medical Center

    Columbus, Ohio, 43215

  • The Mark H Zangmeister Center

    Columbus, Ohio, 43219

  • Mount Carmel Health Center West

    Columbus, Ohio, 43222

  • Doctors Hospital

    Columbus, Ohio, 43228

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

  • Delaware Health Center-Grady Cancer Center

    Delaware, Ohio, 43015

  • Grady Memorial Hospital

    Delaware, Ohio, 43015

  • Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

  • Henry Ford Health Saint John Hospital

    Detroit, Michigan, 48236

  • Dublin Methodist Hospital

    Dublin, Ohio, 43016

  • Henry Ford River District Hospital

    East China, Michigan, 48054

  • Pocono Medical Center

    East Stroudsburg, Pennsylvania, 18301

  • Cancer Hematology Centers - Flint

    Flint, Michigan, 48503

  • Genesee Hematology Oncology PC

    Flint, Michigan, 48503

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

  • Hurley Medical Center

    Flint, Michigan, 48503

  • McLeod Regional Medical Center

    Florence, South Carolina, 29506

  • Holy Cross Hospital

    Fort Lauderdale, Florida, 33308

  • Mercy Hospital Fort Smith

    Fort Smith, Arkansas, 72903

  • Gibbs Cancer Center-Gaffney

    Gaffney, South Carolina, 29341

  • Central Ohio Breast and Endocrine Surgery

    Gahanna, Ohio, 43230

  • Prisma Health Greenville Memorial Hospital

    Greenville, South Carolina, 29605

  • Prisma Health Cancer Institute - Eastside

    Greenville, South Carolina, 29615

  • Gibbs Cancer Center-Pelham

    Greer, South Carolina, 29651

  • Henry Ford Saint John Hospital - Academic

    Grosse Pointe Woods, Michigan, 48236

  • Henry Ford Saint John Hospital - Breast

    Grosse Pointe Woods, Michigan, 48236

  • Henry Ford Saint John Hospital - Van Elslander

    Grosse Pointe Woods, Michigan, 48236

  • Mount Carmel Grove City Hospital

    Grove City, Ohio, 43123

  • Lehigh Valley Hospital-Hazleton

    Hazleton, Pennsylvania, 18201

  • Island Urology-Hilo

    Hilo, Hawaii, 96720

  • Hawaii Cancer Care Inc - Waterfront Plaza

    Honolulu, Hawaii, 96813

  • Island Urology

    Honolulu, Hawaii, 96813

  • Queen's Cancer Cenrer - POB I

    Honolulu, Hawaii, 96813

  • Queen's Medical Center

    Honolulu, Hawaii, 96813

  • Straub Clinic and Hospital

    Honolulu, Hawaii, 96813

  • University of Hawaii Cancer Center

    Honolulu, Hawaii, 96813

  • Hawaii Cancer Care Inc-Liliha

    Honolulu, Hawaii, 96817

  • Kuakini Medical Center

    Honolulu, Hawaii, 96817

  • Queen's Cancer Center - Kuakini

    Honolulu, Hawaii, 96817

  • The Cancer Center of Hawaii-Liliha

    Honolulu, Hawaii, 96817

  • Kapiolani Medical Center for Women and Children

    Honolulu, Hawaii, 96826

  • Northwell Health/Center for Advanced Medicine

    Lake Success, New York, 11042

  • Fairfield Medical Center

    Lancaster, Ohio, 43130

  • University of Michigan Health - Sparrow Lansing

    Lansing, Michigan, 48912

  • Wilcox Memorial Hospital and Kauai Medical Clinic

    Lihue, Hawaii, 96766

  • Hope Cancer Clinic

    Livonia, Michigan, 48154

  • Trinity Health Saint Mary Mercy Livonia Hospital

    Livonia, Michigan, 48154

  • Henry Ford Saint John Hospital - Macomb Medical

    Macomb, Michigan, 48044

  • Henry Ford Warren Hospital - Breast Macomb

    Macomb, Michigan, 48044

  • OhioHealth Mansfield Hospital

    Mansfield, Ohio, 44903

  • Marietta Memorial Hospital

    Marietta, Ohio, 45750

  • OhioHealth Marion General Hospital

    Marion, Ohio, 43302

  • Saint Mary's Oncology/Hematology Associates of Marlette

    Marlette, Michigan, 48453

  • SSM Health Good Samaritan

    Mount Vernon, Illinois, 62864

  • Knox Community Hospital

    Mount Vernon, Ohio, 43050

  • ThedaCare Regional Medical Center - Neenah

    Neenah, Wisconsin, 54956

  • Licking Memorial Hospital

    Newark, Ohio, 43055

  • Newark Radiation Oncology

    Newark, Ohio, 43055

  • Hope Cancer Center

    Pontiac, Michigan, 48341

  • Michigan Healthcare Professionals Pontiac

    Pontiac, Michigan, 48341

  • Newland Medical Associates-Pontiac

    Pontiac, Michigan, 48341

  • Trinity Health Saint Joseph Mercy Oakland Hospital

    Pontiac, Michigan, 48341

  • Southern Ohio Medical Center

    Portsmouth, Ohio, 45662

  • Henry Ford Rochester Hospital

    Rochester Hills, Michigan, 48309

  • Mercy Clinic-Rolla-Cancer and Hematology

    Rolla, Missouri, 65401

  • MyMichigan Medical Center Saginaw

    Saginaw, Michigan, 48601

  • Oncology Hematology Associates of Saginaw Valley PC

    Saginaw, Michigan, 48604

  • ThedaCare Cancer Care - Shawano

    Shawano, Wisconsin, 54166

  • Spartanburg Medical Center

    Spartanburg, South Carolina, 29303

  • Mercy Medical Center

    Springfield, Massachusetts, 01104

  • Mercy Hospital Springfield

    Springfield, Missouri, 65804

  • Mercy Hospital South

    St Louis, Missouri, 63128

  • Mercy Hospital Saint Louis

    St Louis, Missouri, 63141

  • Bhadresh Nayak MD PC-Sterling Heights

    Sterling Heights, Michigan, 48312

  • MyMichigan Medical Center Tawas

    Tawas City, Michigan, 48764

  • SMC Center for Hematology Oncology Union

    Union, South Carolina, 29379

  • Advanced Breast Care Center PLLC

    Warren, Michigan, 48088

  • Henry Ford Health Warren Hospital

    Warren, Michigan, 48093

  • Henry Ford Madison Heights Hospital - Breast

    Warren, Michigan, 48093

  • Henry Ford Warren Hospital - GLCMS

    Warren, Michigan, 48093

  • Macomb Hematology Oncology PC

    Warren, Michigan, 48093

  • MedStar Washington Hospital Center

    Washington D.C., District of Columbia, 20010

  • Aspirus Regional Cancer Center

    Wausau, Wisconsin, 54401

  • Saint Mary's Oncology/Hematology Associates of West Branch

    West Branch, Michigan, 48661

  • Saint Ann's Hospital

    Westerville, Ohio, 43081

  • Huron Gastroenterology PC

    Ypsilanti, Michigan, 48106

  • Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

    Ypsilanti, Michigan, 48197

  • Genesis Healthcare System Cancer Care Center

    Zanesville, Ohio, 43701

Other trials in United States

About this study

Official title: Implementing Palliative Care: Learning Collaborative vs. Technical Assistance

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. 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:

  1. 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:

  1. 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.

Being tested
Behavioral, Psychological or Informational Intervention, Educational Intervention, Medical Examination Assessment, Quality-of-Life Assessment, Survey Administration
Medical subject headings
Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Behavioral, Psychological or Informational InterventionOther

    Receive ENABLE palliative care information

  • Educational InterventionOther

    Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

    Participate in VLC group-based learning sessions

  • Educational InterventionOther

    Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

    Participate in consultation with ENABLE/TA expert

  • Medical Examination AssessmentProcedure or surgery

    Also called Exam, Examination, Health Assessment, Health Examination

    Undergo palliative care assessment

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

  • Survey AdministrationOther

    Complete surveys

  • Telephone-Based InterventionBehavioural

    Receive monthly phone calls

Study groups in NCT04062552
Study groupRoleWhat they receive
Group I (ENABLE palliative care program, phone calls, VLC)ExperimentalPatients 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.
Receives: Other: Behavioral, Psychological or Informational Intervention; Other: Educational Intervention; Procedure: Medical Examination Assessment; Other: Quality-of-Life Assessment; Other: Survey Administration; Behavioral: Telephone-Based Intervention
Group II (ENABLE palliative care program, phone calls, TA)ExperimentalPatients 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.
Receives: Other: Behavioral, Psychological or Informational Intervention; Other: Educational Intervention; Procedure: Medical Examination Assessment; Other: Quality-of-Life Assessment; Other: Survey Administration; Behavioral: Telephone-Based Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 24 weeks

Secondary outcomes (2)

  1. 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.

    Measured: At 24 weeks

  2. 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.

    Measured: Up to 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Aug 2019
  2. Study start9 Mar 2021
  3. Primary completion16 Sep 2025
  4. Study completion23 Aug 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
208 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04062552
Sponsor's protocol ID
URCC18110CD
Other IDs
NCI-2019-02246, URCC18110CD_, URCC18110CD, URCC-18110CD, URCC-18110CD, R01CA229197, UG1CA189961
Status last verified
Jan 2026
First submitted
12 Aug 2019
Last updated
13 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 41761561

  • 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.

    PubMed 33706770

Questions about this trial

What is this clinical trial studying?

A study testing Behavioral, Psychological or Informational Intervention, Educational Intervention and Medical Examination Assessment in people with Advanced Malignant Solid Neoplasm and Metastatic Malignant Solid Neoplasm, run by University of Rochester NCORP Research Base at 113 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 113 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient completion of the Educate, Nurture, Advise, Before Life Ends (ENABLE) program (time frame: Up to 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04062552, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.

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