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Palliative Care Oncology in Relapsed, Refractory, and High-Risk Leukemia Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04482894
Recruitment Status : Recruiting
First Posted : July 23, 2020
Last Update Posted : August 24, 2020
Sponsor:
Information provided by (Responsible Party):
Karen Ballen, MD, University of Virginia

Brief Summary:
The purpose of this study is to estimate the potential benefit of early and continued palliative care (PC) consultation on end of life issues.

Condition or disease Intervention/treatment Phase
Leukemia, Acute AML, Adult ALL, Adult Other: Palliative Care Visits Phase 2

Detailed Description:

Participants in this study will be randomized to either an intervention group or a standard of care group. Participants in the intervention group will participate in regular visits with a palliative (or supportive) care specialist, while participants in the standard of care group will only see palliative care specialists if the clinician requests a referral. All participants will be asked to complete monthly questionnaires regarding their general well-being.

Participants have a greater chance of being assigned to the intervention group than to the standard of care group. On average, in every 5 people randomized, 3 will be randomized to the intervention and 2 will be randomized to standard of care.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Palliative Care Oncology in Relapsed, Refractory, and High-Risk Leukemia Patients: Randomized Phase 2 Study
Actual Study Start Date : August 19, 2020
Estimated Primary Completion Date : September 1, 2023
Estimated Study Completion Date : April 1, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Palliative Care Intervention
Participants on this arm will see a palliative care specialist twice a week while they are in the hospital and about every other week when they are out of the hospital. If participants see their oncologist less often than every other week while they're out of the hospital, then visits with the palliative care specialist would be timed to occur on the same day as the oncologist visit. Participants will complete a questionnaire about once a month.
Other: Palliative Care Visits
Regular visits with a palliative (supportive) care specialist

No Intervention: Standard Clinical Care
Participants will see a palliative care specialist only if they have a referral from their oncologist according to standard clinical care. Participants on this arm will not be discouraged from requesting a consult.



Primary Outcome Measures :
  1. Place of death [ Time Frame: At the time of death (for participants that die), assessed from enrollment through study completion, an average of 2 years ]
    Location of death (ICU, inpatient floor, hospice, home)


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: From enrollment through participant death or end of study from enrollment through participant death or study completion, an average of 2 years. ]
    Time from enrollment through death (for participants that die)

  2. Duration of hospitalizations [ Time Frame: From enrollment through participant death or study completion, an average of 2 years. ]
    Duration of hospitalizations

  3. Type(s) of hospitalizations [ Time Frame: From enrollment through participant death or study completion, an average of 2 years. ]
    Type(s) of hospitalizations

  4. Frequency of hospitalizations [ Time Frame: From enrollment through participant death or study completion, an average of 2 years. ]
    Frequency of hospitalizations

  5. Emergency department visits [ Time Frame: From enrollment through participant death or study completion, an average of 2 years. ]
    Frequency/Number of emergency department visits

  6. Hospice services use [ Time Frame: From enrollment through participant death or study completion, an average of 2 years. ]
    Dates of use of hospice services

  7. Transfusions [ Time Frame: From enrollment through participant death or study completion, an average of 2 years. ]
    Frequency/number and types of transfusions received

  8. Quality of life measure [ Time Frame: At time of enrollment, and then once a month during participation through participant death or study completion, an average of 2 years. ]
    Quality of life based on FACT-Leukemia questionnaire, scored from 0 to 176, with a higher score indicating better quality of life

  9. Code status change [ Time Frame: From enrollment through participant death or study completion, an average of 2 years. ]
    Dates and types of changes to code status (e.g. Do not rescuscitate (DNR) with details)

  10. Goals of Care (GOC) Discussions [ Time Frame: From enrollment through participant death or study completion, an average of 2 years. ]
    Whether a GOC discussion occurs while on study, and if so, date and location of discussion



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:   No
Criteria

Inclusion Criteria:

  1. Ability to provide informed consent
  2. Stated willingness to comply with all study procedures and availability for the duration of the study
  3. Either of the following:

    1. Patients with a new diagnosis of AML or ALL who are age 65 and older. OR
    2. Patients with relapsed AML and ALL, ages 18 and older. OR
    3. Patients with refractory AML and ALL, ages 18 and older.

Refractory AML/ALL will be defined as persistent leukemia despite two or more cycles of induction chemotherapy.

Exclusion Criteria:

1. Inability to speak, read and comprehend either English or Spanish.


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): NCT04482894


Contacts
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Contact: Emily Leytham (434) 924-7621 EL5MF@hscmail.mcc.virginia.edu
Contact: Emily Hoade (434) 243-3983 ESH5RQ@hscmail.mcc.virginia.edu

Locations
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United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22903
Contact: Emily Leytham    434-924-7621    EL5MF@hscmail.mcc.virginia.edu   
Contact: Emily Hoade    (434) 243-3983    ESH5RQ@hscmail.mcc.virginia.edu   
Sponsors and Collaborators
University of Virginia
Investigators
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Principal Investigator: Karen Ballen, MD University of Virginia
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Responsible Party: Karen Ballen, MD, Professor, University of Virginia
ClinicalTrials.gov Identifier: NCT04482894    
Other Study ID Numbers: HSR 200133
First Posted: July 23, 2020    Key Record Dates
Last Update Posted: August 24, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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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Leukemia
Neoplasms by Histologic Type
Neoplasms