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

January 10, 2026 updated by: Supriya Mohile, University of Rochester NCORP Research Base

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

208

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Fort Smith, Arkansas, United States, 72903
        • Mercy Hospital Fort Smith
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
        • Medstar Washington Hospital Center
    • Florida
      • Fort Lauderdale, Florida, United States, 33308
        • Holy Cross Hospital
    • Hawaii
      • Hilo, Hawaii, United States, 96720
        • Island Urology-Hilo
      • Honolulu, Hawaii, United States, 96813
        • Queen's Medical Center
      • Honolulu, Hawaii, United States, 96817
        • The Cancer Center of Hawaii-Liliha
      • Honolulu, Hawaii, United States, 96813
        • Hawaii Cancer Care Inc - Waterfront Plaza
      • Honolulu, Hawaii, United States, 96813
        • Queen's Cancer Cenrer - POB I
      • Honolulu, Hawaii, United States, 96813
        • Straub Clinic and Hospital
      • Honolulu, Hawaii, United States, 96813
        • University of Hawaii Cancer Center
      • Honolulu, Hawaii, United States, 96817
        • Hawaii Cancer Care Inc-Liliha
      • Honolulu, Hawaii, United States, 96817
        • Kuakini Medical Center
      • Honolulu, Hawaii, United States, 96817
        • Queen's Cancer Center - Kuakini
      • Honolulu, Hawaii, United States, 96826
        • Kapiolani Medical Center for Women and Children
      • Honolulu, Hawaii, United States, 96813
        • Island Urology
      • Lihue, Hawaii, United States, 96766
        • Wilcox Memorial Hospital and Kauai Medical Clinic
      • ‘Aiea, Hawaii, United States, 96701
        • Hawaii Cancer Care - Westridge
      • ‘Aiea, Hawaii, United States, 96701
        • Pali Momi Medical Center
      • ‘Aiea, Hawaii, United States, 96701
        • Queen's Cancer Center - Pearlridge
      • ‘Aiea, Hawaii, United States, 96701
        • The Cancer Center of Hawaii-Pali Momi
    • Illinois
      • Centralia, Illinois, United States, 62801
        • Saint Mary's Hospital
      • Mount Vernon, Illinois, United States, 62864
        • SSM Health Good Samaritan
    • Iowa
      • Des Moines, Iowa, United States, 50314
        • Mercy Medical Center - Des Moines
    • Massachusetts
      • Springfield, Massachusetts, United States, 01104
        • Mercy Medical Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48106
        • Trinity Health Saint Joseph Mercy Hospital Ann Arbor
      • Brighton, Michigan, United States, 48114
        • Trinity Health IHA Medical Group Hematology Oncology - Brighton
      • Brighton, Michigan, United States, 48114
        • Trinity Health Medical Center - Brighton
      • Canton, Michigan, United States, 48188
        • Trinity Health IHA Medical Group Hematology Oncology - Canton
      • Canton, Michigan, United States, 48188
        • Trinity Health Medical Center - Canton
      • Caro, Michigan, United States, 48723
        • Caro Cancer Center
      • Chelsea, Michigan, United States, 48118
        • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
      • Chelsea, Michigan, United States, 48118
        • Chelsea Hospital
      • Clarkston, Michigan, United States, 48346
        • Hematology Oncology Consultants-Clarkston
      • Clarkston, Michigan, United States, 48346
        • Newland Medical Associates-Clarkston
      • Detroit, Michigan, United States, 48236
        • Henry Ford Health Saint John Hospital
      • East China, Michigan, United States, 48054
        • Henry Ford River District Hospital
      • Flint, Michigan, United States, 48503
        • Hurley Medical Center
      • Flint, Michigan, United States, 48503
        • Genesee Hematology Oncology PC
      • Flint, Michigan, United States, 48503
        • Genesys Hurley Cancer Institute
      • Flint, Michigan, United States, 48503
        • Cancer Hematology Centers - Flint
      • Grosse Pointe Woods, Michigan, United States, 48236
        • Henry Ford Saint John Hospital - Academic
      • Grosse Pointe Woods, Michigan, United States, 48236
        • Henry Ford Saint John Hospital - Breast
      • Grosse Pointe Woods, Michigan, United States, 48236
        • Henry Ford Saint John Hospital - Van Elslander
      • Lansing, Michigan, United States, 48912
        • University of Michigan Health - Sparrow Lansing
      • Livonia, Michigan, United States, 48154
        • Trinity Health Saint Mary Mercy Livonia Hospital
      • Livonia, Michigan, United States, 48154
        • Hope Cancer Clinic
      • Macomb, Michigan, United States, 48044
        • Henry Ford Warren Hospital - Breast Macomb
      • Macomb, Michigan, United States, 48044
        • Henry Ford Saint John Hospital - Macomb Medical
      • Marlette, Michigan, United States, 48453
        • Saint Mary's Oncology/Hematology Associates of Marlette
      • Pontiac, Michigan, United States, 48341
        • Hope Cancer Center
      • Pontiac, Michigan, United States, 48341
        • Newland Medical Associates-Pontiac
      • Pontiac, Michigan, United States, 48341
        • Trinity Health Saint Joseph Mercy Oakland Hospital
      • Pontiac, Michigan, United States, 48341
        • Michigan Healthcare Professionals Pontiac
      • Rochester Hills, Michigan, United States, 48309
        • Henry Ford Rochester Hospital
      • Saginaw, Michigan, United States, 48604
        • Oncology Hematology Associates of Saginaw Valley PC
      • Saginaw, Michigan, United States, 48601
        • MyMichigan Medical Center Saginaw
      • Sterling Heights, Michigan, United States, 48312
        • Bhadresh Nayak MD PC-Sterling Heights
      • Tawas City, Michigan, United States, 48764
        • MyMichigan Medical Center Tawas
      • Warren, Michigan, United States, 48088
        • Advanced Breast Care Center PLLC
      • Warren, Michigan, United States, 48093
        • Macomb Hematology Oncology PC
      • Warren, Michigan, United States, 48093
        • Henry Ford Madison Heights Hospital - Breast
      • Warren, Michigan, United States, 48093
        • Henry Ford Health Warren Hospital
      • Warren, Michigan, United States, 48093
        • Henry Ford Warren Hospital - GLCMS
      • West Branch, Michigan, United States, 48661
        • Saint Mary's Oncology/Hematology Associates of West Branch
      • Ypsilanti, Michigan, United States, 48197
        • Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
      • Ypsilanti, Michigan, United States, 48106
        • Huron Gastroenterology PC
    • Missouri
      • Rolla, Missouri, United States, 65401
        • Mercy Clinic-Rolla-Cancer and Hematology
      • Springfield, Missouri, United States, 65804
        • Mercy Hospital Springfield
      • St Louis, Missouri, United States, 63141
        • Mercy Hospital Saint Louis
      • St Louis, Missouri, United States, 63128
        • Mercy Hospital South
    • New York
      • Lake Success, New York, United States, 11042
        • Northwell Health/Center for Advanced Medicine
    • Ohio
      • Belpre, Ohio, United States, 45714
        • Strecker Cancer Center-Belpre
      • Chillicothe, Ohio, United States, 45601
        • Adena Regional Medical Center
      • Columbus, Ohio, United States, 43214
        • Riverside Methodist Hospital
      • Columbus, Ohio, United States, 43219
        • The Mark H Zangmeister Center
      • Columbus, Ohio, United States, 43214
        • Columbus Oncology and Hematology Associates Inc
      • Columbus, Ohio, United States, 43228
        • Doctors Hospital
      • Columbus, Ohio, United States, 43213
        • Mount Carmel East Hospital
      • Columbus, Ohio, United States, 43215
        • Grant Medical Center
      • Columbus, Ohio, United States, 43222
        • Mount Carmel Health Center West
      • Delaware, Ohio, United States, 43015
        • Delaware Health Center-Grady Cancer Center
      • Delaware, Ohio, United States, 43015
        • Grady Memorial Hospital
      • Dublin, Ohio, United States, 43016
        • Dublin Methodist Hospital
      • Gahanna, Ohio, United States, 43230
        • Central Ohio Breast and Endocrine Surgery
      • Grove City, Ohio, United States, 43123
        • Mount Carmel Grove City Hospital
      • Lancaster, Ohio, United States, 43130
        • Fairfield Medical Center
      • Mansfield, Ohio, United States, 44903
        • OhioHealth Mansfield Hospital
      • Marietta, Ohio, United States, 45750
        • Marietta Memorial Hospital
      • Marion, Ohio, United States, 43302
        • OhioHealth Marion General Hospital
      • Mount Vernon, Ohio, United States, 43050
        • Knox Community Hospital
      • Newark, Ohio, United States, 43055
        • Licking Memorial Hospital
      • Newark, Ohio, United States, 43055
        • Newark Radiation Oncology
      • Portsmouth, Ohio, United States, 45662
        • Southern Ohio Medical Center
      • Westerville, Ohio, United States, 43081
        • Saint Ann's Hospital
      • Zanesville, Ohio, United States, 43701
        • Genesis Healthcare System Cancer Care Center
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Lehigh Valley Hospital-Cedar Crest
      • Bethlehem, Pennsylvania, United States, 18017
        • Lehigh Valley Hospital - Muhlenberg
      • Danville, Pennsylvania, United States, 17822
        • Geisinger Medical Center
      • East Stroudsburg, Pennsylvania, United States, 18301
        • Pocono Medical Center
      • Hazleton, Pennsylvania, United States, 18201
        • Lehigh Valley Hospital-Hazleton
    • South Carolina
      • Charleston, South Carolina, United States, 29401
        • Roper Hospital
      • Charleston, South Carolina, United States, 29414
        • Bon Secours Saint Francis Hospital
      • Florence, South Carolina, United States, 29506
        • McLeod Regional Medical Center
      • Gaffney, South Carolina, United States, 29341
        • Gibbs Cancer Center-Gaffney
      • Greenville, South Carolina, United States, 29615
        • Prisma Health Cancer Institute - Eastside
      • Greenville, South Carolina, United States, 29605
        • Prisma Health Greenville Memorial Hospital
      • Greer, South Carolina, United States, 29651
        • Gibbs Cancer Center-Pelham
      • Spartanburg, South Carolina, United States, 29303
        • Spartanburg Medical Center
      • Union, South Carolina, United States, 29379
        • SMC Center for Hematology Oncology Union
    • Wisconsin
      • Appleton, Wisconsin, United States, 54911
        • ThedaCare Regional Cancer Center
      • Neenah, Wisconsin, United States, 54956
        • ThedaCare Regional Medical Center - Neenah
      • Shawano, Wisconsin, United States, 54166
        • ThedaCare Cancer Care - Shawano
      • Wausau, Wisconsin, United States, 54401
        • Aspirus Regional Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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: Group I (ENABLE palliative care program, phone calls, VLC)
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: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Other: Survey Administration
Complete surveys
Other: Behavioral, Psychological or Informational Intervention
Receive ENABLE palliative care information
Other: Educational Intervention
Participate in VLC group-based learning sessions
Other Names:
  • Education for Intervention
  • Intervention by Education
  • Intervention through Education
  • Intervention, Educational
Other: Educational Intervention
Participate in consultation with ENABLE/TA expert
Other Names:
  • Education for Intervention
  • Intervention by Education
  • Intervention through Education
  • Intervention, Educational
Behavioral: Telephone-Based Intervention
Receive monthly phone calls
Procedure: Medical Examination Assessment
Undergo palliative care assessment
Other Names:
  • Exam
  • Examination
  • Medical Assessment
  • Medical Exam
  • Medical Inspection
  • Health Assessment
  • Health Status Assessment
  • Health Examination
Experimental: Group II (ENABLE palliative care program, phone calls, TA)
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.
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Other: Survey Administration
Complete surveys
Other: Behavioral, Psychological or Informational Intervention
Receive ENABLE palliative care information
Other: Educational Intervention
Participate in VLC group-based learning sessions
Other Names:
  • Education for Intervention
  • Intervention by Education
  • Intervention through Education
  • Intervention, Educational
Other: Educational Intervention
Participate in consultation with ENABLE/TA expert
Other Names:
  • Education for Intervention
  • Intervention by Education
  • Intervention through Education
  • Intervention, Educational
Behavioral: Telephone-Based Intervention
Receive monthly phone calls
Procedure: Medical Examination Assessment
Undergo palliative care assessment
Other Names:
  • Exam
  • Examination
  • Medical Assessment
  • Medical Exam
  • Medical Inspection
  • Health Assessment
  • Health Status Assessment
  • Health Examination

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient completion of the Educate, Nurture, Advise, Before Life Ends (ENABLE) program
Time Frame: Up to 24 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preliminary effectiveness of VLC or TA on patient quality of life and mood outcomes
Time Frame: At 24 weeks
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.
At 24 weeks
Relationship between ENABLE program uptake and patient outcomes
Time Frame: Up to 24 weeks
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

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
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.
At 24 weeks
Patient quality of life, assessed using the FACIT-Pal.
Time Frame: At 24 weeks
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.
At 24 weeks
Caregiver mood, using the Hospital Anxiety and Depression Scale (HADS).
Time Frame: At 24 weeks
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.
At 24 weeks
Caregiver quality of life, Measured by the Patient Reported Outcomes Measurement Information System (PROMIS) Global Health
Time Frame: At 24 weeks
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).
At 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rochester NCORP Research Base

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Lisa Zubkoff, PhD, University of Rochester NCORP Research Base

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 9, 2021

Primary Completion (Actual)

September 16, 2025

Study Completion (Estimated)

August 23, 2026

Study Registration Dates

First Submitted

August 12, 2019

First Submitted That Met QC Criteria

August 19, 2019

First Posted (Actual)

August 20, 2019

Study Record Updates

Last Update Posted (Estimated)

January 13, 2026

Last Update Submitted That Met QC Criteria

January 10, 2026

Last Verified

January 1, 2026

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)
  • URCC18110CD_

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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