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

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ClinicalTrials.gov Identifier: NCT04062552
Recruitment Status : Enrolling by invitation
First Posted : August 20, 2019
Last Update Posted : December 21, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Supriya Mohile, University of Rochester NCORP Research Base

Brief Summary:
This trial studies the delivery of the ENABLE palliative care program by two different methods called a Virtual Learning Collaborative or Technical Assistance for patients with advanced cancer and their caregivers. Palliative care is specialized medical care for people with a serious illness that occurs at the same time as other medical treatment. The purpose of palliative care is to provide relief from symptoms and stress of serious illness, to help patients and their families clarify goals of care, and to focus on social support and spiritual well-being. The focus of the ENABLE palliative care program is on living well, managing stress, patient communication of their personal values and hopes for care, social support, and symptom management. This study may help doctors find the best ways to include palliative care services into their practices and the impact of palliative care on cancer patients and their caregivers' quality of life.

Condition or disease Intervention/treatment Phase
Advanced Malignant Solid Neoplasm Caregiver Metastatic Malignant Solid Neoplasm Nurse Nurse Practitioner Oncologist Physician Assistant Progressive Neoplastic Disease Recurrent Malignant Solid Neoplasm Other: Behavioral, Psychological or Informational Intervention Other: Educational Intervention Procedure: Medical Examination Other: Quality-of-Life Assessment Other: Survey Administration Behavioral: Telephone-Based Intervention Not Applicable

Detailed Description:

PRIMARY OBJECTIVES:

I. Compare the effectiveness of Virtual Learning Collaborative (VLC) versus (vs.) Technical Assistance (TA) on Educate, Nurture, Advise, Before Life Ends (ENABLE) program uptake, as measured by the proportion of patients who complete the ENABLE program, defined as having a palliative care assessment and completing the 6 ENABLE sessions. (Implementation Outcome, Patient Level)

SECONDARY OBJECTIVES:

I. Compare the effectiveness of VLC vs. TA on National Cancer Institute Oncology Research Program (NCORP) practices' overall ENABLE program implementation, as measured by the General Organizational Index (GOI) (Service Outcome, Practice Level)

EXPLORATORY OBJECTIVES:

I. Compare NCORP practices randomized to VLC or TA on patient and caregiver quality of life (QOL) and mood outcomes. (Patient & Caregiver Outcomes) II. Determine the relationship among ENABLE program uptake, 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 a nurse coach over 20-40 minutes, and monthly follow-up calls for 6 months. Caregivers participate in 3 ENABLE sessions with a nurse 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 a nurse coach over 20-40 minutes, and monthly follow-up calls for 6 months. Caregivers participate in 3 ENABLE sessions with a nurse 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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1296 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Implementing Palliative Care: Learning Collaborative vs. Technical Assistance
Actual Study Start Date : August 13, 2019
Estimated Primary Completion Date : March 1, 2023
Estimated Study Completion Date : October 24, 2023

Resource links provided by the National Library of Medicine


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 a nurse coach over 20-40 minutes, and monthly follow-up calls for 6 months. Caregivers participate in 3 ENABLE sessions with a nurse 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: 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

Procedure: Medical Examination
Undergo palliative care assessment
Other Names:
  • Exam
  • Examination
  • Medical Assessment
  • Medical Exam
  • Medical Inspection

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Survey Administration
Complete surveys

Behavioral: Telephone-Based Intervention
Receive monthly phone calls

Experimental: Group II (ENABLE palliative care program, phone calls, TA)
Patients undergo a palliative care assessment, participate in 6 ENABLE phone-based sessions with a nurse coach over 20-40 minutes, and monthly follow-up calls for 6 months. Caregivers participate in 3 ENABLE sessions with a nurse 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: Behavioral, Psychological or Informational Intervention
Receive ENABLE palliative care information

Other: Educational Intervention
Participate in consultation with ENABLE/TA expert
Other Names:
  • Education for Intervention
  • Intervention by Education
  • Intervention through Education
  • Intervention, Educational

Procedure: Medical Examination
Undergo palliative care assessment
Other Names:
  • Exam
  • Examination
  • Medical Assessment
  • Medical Exam
  • Medical Inspection

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Survey Administration
Complete surveys

Behavioral: Telephone-Based Intervention
Receive monthly phone calls




Primary Outcome Measures :
  1. 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 all 6 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 all ENABLE program sessions prior to the 12 week assessments and "no" if the patient is still alive but has not completed a palliative care assessment and all six ENABLE program sessions prior to the 12 week assessments), 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.


Secondary Outcome Measures :
  1. Practice completion of the implementation strategy (either Virtual Learning Collaborative [VLC] or Technical Assistance [TA]) and all associated implementation measures [ Time Frame: Up to 24 weeks ]
    Due to the small sample size for specific practice-level outcomes (24 VLC versus 24 TA), rather than conducting formal inference, practice-service outcome (i.e., ENABLE program implementation) comparisons will be descriptive statistics and effect size measures. Will use ENABLE General Organizational Index scores to calculate descriptive statistics and effect sizes to describe ENABLE program implementation at each practice cluster.


Other Outcome Measures:
  1. 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.

  2. 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.

  3. 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.

  4. 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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • NCORP PRACTICE: All participating practice clusters will be required to identify two (or more) ENABLE nurse coaches as part of study eligibility to deliver the ENABLE program. For practices that only have 1 nurse available, we will allow only 1 ENABLE nurse coach.
  • NCORP PRACTICE: Commitment of the ENABLE nurse coach(es) to be trained to conduct the palliative care assessment and sessions.
  • NCORP PRACTICE: 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.
  • NCORP PRACTICE: Demonstrated support/buy-in from oncology physicians who are willing to enroll patients.
  • NCORP PRACTICE: Agreement of practice leadership and staff to support/participate in the study activities.
  • NCORP practice: If necessary, willingness to participate in a phone interview to determine capacity to implement the ENABLE program.
  • NCORP PRACTICE STAFF: The ENABLE implementation team at each participating practice will include at minimum the ENABLE nurse coach(es) 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).
  • ONCOLOGY PHYSICIAN: Eligible providers at NCORP practices are oncology physicians (i.e., medical oncologists or radiation oncologists) caring for oncology patients. We do not require that all physicians at a practice setting agree to participate. Oncology physicians must work at an NCORP practice cluster with no plans to leave that NCORP practice or retire at the time of enrollment into the study.
  • ENABLE NURSE COACH: NCORP practices will identify a nurse (registered nurse) or an advanced practice provider (including a nurse practitioner or physician assistant) with experience in oncology or palliative care to serve as the ENABLE nurse coach.
  • ENABLE NURSE COACH: All ENABLE nurse coaches will be licensed and have a minimum of two years of experience caring for patients with cancer in either an oncology or palliative care setting.
  • ENABLE NURSE COACH: All ENABLE nurse coaches are required to complete training by the study team in conducting the palliative care assessment and the ENABLE sessions.
  • PATIENTS: English-speaking as not all patient measures have been validated in other languages.
  • 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: Expected survival of at least 6 months.
  • PATIENTS: Have access to telephone that can receive calls.
  • PATIENTS: Able to provide informed consent.
  • CAREGIVERS: English-speaking as not all caregiver measures have been validated in other languages.
  • CAREGIVERS: Willing to complete the ENABLE sessions.
  • CAREGIVERS: Selected by the patient when asked if there is a ?unpaid relative or friend who knows them well and who provides regular support to their cancer.?
  • CAREGIVERS: Have access to telephone that can receive calls.
  • CAREGIVERS: Able to provide informed consent.

Exclusion Criteria:

  • PATIENTS: Received previous palliative care services.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04062552


Locations
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United States, New York
University of Rochester
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester NCORP Research Base
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Lisa Zubkoff, PhD Dartmouth College
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Responsible Party: Supriya Mohile, Professor, University of Rochester NCORP Research Base
ClinicalTrials.gov Identifier: NCT04062552    
Other Study ID Numbers: URCC18110CD
NCI-2019-02246 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
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 )
UG1CA189961 ( U.S. NIH Grant/Contract )
First Posted: August 20, 2019    Key Record Dates
Last Update Posted: December 21, 2020
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms