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NCT Number: NCT04482894

Palliative Care Oncology in Patients With Relapsed, Refractory, and High-Risk Leukemias or MDS

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Leukemia, Acute ALL, Adult AML, Adult Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Leukemia, Myeloid Leukemia, Myeloid, Acute Lymphatic Diseases Lymphoproliferative Disorders Myelodysplastic Syndromes Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Virginia

Charlottesville, Virginia, 22903, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ability to provide informed consent
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Any of the following:
  • Patients with a new diagnosis of AML, ALL, high risk myelodysplastic syndrome (MDS), or high risk chronic myelomonocytic leukemia (CMML) who are age 65 and older.

OR

  • Patients with relapsed AML, ALL, high risk MDS or high risk CMML, ages 18 and older.

OR

  • Patients with refractory AML, ALL, high risk MDS or high risk CMML, ages 18 and older.

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

Refractory MDS will be defined according to the 2006 IWG response criteria Refractory CMML will be based on the assessment of the treating investigator.

Exclusion criteria

  • Participants must not have a diagnosis of Acute Promyelocytic Leukemia (APL)

Treatment and study plan

Palliative Care Visits

Other

Regular visits with a palliative (supportive) care specialist

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Registry information

Official study title

Palliative Care Oncology in Patients With Relapsed, Refractory, and High-Risk Leukemias or High-Risk Myelodysplastic Syndrome: Randomized Phase II Study

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Jul 23, 2020
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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