Primary Palliative Care for Patients With Advanced Hematologic Malignancies
NCT ID: NCT02992171
Last Updated: 2020-04-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2017-05-02
2020-03-19
Brief Summary
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Detailed Description
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Aim 1 is a case series to develop and refine the intervention. During this time, we will develop initial interventionist training materials, study protocols, and a web-based outcomes database; train 2 hematology-oncology nurses; enroll 10 patients with advanced hematologic malignancies and their informal caregivers to receive intervention visits; conduct debriefing interviews; iteratively refine the intervention based on nurse, oncologist, patient, and caregiver feedback; and prepare the protocol for Aim 2. Aim 2 is a pilot study to assess the feasibility and acceptability of administering the intervention and assessing outcomes. We will recruit 30 patients and their informal caregivers to receive the intervention developed in Aim 1 and collect measures of quality of life, symptom burden, anxiety and depressive symptoms, caregiver burden, and healthcare utilization at baseline and monthly for up to three months. Trial outcomes will include: rates of enrollment, study completion, and outcome completion; intervention fidelity; and self-reported measures of study burdensomeness and effectiveness among patients, caregivers, and clinicians.
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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care management by oncology nurses
The intervention employs a care management approach to facilitate provision of primary palliative care within existing oncology clinic structures. The intervention is deployed through a series of nurse-led encounters occurring before or after regularly-scheduled oncology clinic visits.
care management by oncology nurses
The intervention employs a care management approach to facilitate provision of primary palliative care within existing oncology clinic structures. The intervention is deployed through a series of nurse-led encounters occurring before or after regularly-scheduled oncology clinic visits.
Interventions
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care management by oncology nurses
The intervention employs a care management approach to facilitate provision of primary palliative care within existing oncology clinic structures. The intervention is deployed through a series of nurse-led encounters occurring before or after regularly-scheduled oncology clinic visits.
Eligibility Criteria
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Inclusion Criteria
* Refractory or Recurrent hematologic cancer: lymphoma, leukemia, myeloma, amyloidosis (secondary manifestation myeloma \& AL Amyloidosis), and CML (CML can only be accelerated or blast phase)
* planning to receive ongoing care from a participating oncologist and willing to be seen at least monthly.
* adults (≥ 21 years old)
* family member or friend of an eligible patient
Exclusion Criteria
* unable to read and respond to questions in English
* lacks decision-making capacity, as determined by the patient's oncologist
* unable to complete baseline interview
Caregiver
* unable to read and respond to questions in English
* unable to complete the baseline interview (patients will be asked to select as caregiver the person who is most likely to accompany them to visits or help with their care should they need it)
Eligible clinicians will be oncology nurses and oncologists practicing at participating clinics.
21 Years
ALL
No
Sponsors
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American Cancer Society, Inc.
OTHER
University of Pittsburgh
OTHER
Responsible Party
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Yael Schenker, MD, MAS
Assistant Professor Director, Palliative Care Research
Principal Investigators
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Yael Schenker, MD, MAS
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
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UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Countries
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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130225-PEP-16-205-01-PCSM
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
PRO16100199
Identifier Type: -
Identifier Source: org_study_id
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