Palliative Care Intervention in Improving Quality of Life, Psychological Distress, and Communication in Patients With Solid Tumors Receiving Treatment
NCT ID: NCT01828775
Last Updated: 2021-03-10
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
480 participants
INTERVENTIONAL
2014-09-08
2020-05-18
Brief Summary
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Detailed Description
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I. Test the effects of a palliative care intervention (PCI) on patients' quality of life (QOL), psychological distress and satisfaction with communication, comparing the experimental versus control groups.
II. Test the effects of a PCI on patients' symptom intensity and symptom interference with daily activities, comparing the experimental versus control groups.
III. Test the effects of a PCI on patients' hospital and palliative care resource utilization and clinical trial retention rates, comparing the experimental versus control groups.
IV. Test the effects of the timing of PCI initiation (early versus delayed) on patient outcomes, comparing the experimental versus control groups.
V. Describe patients' satisfaction with the PCI.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive part I of the PCI comprising quantitative surveys, comprehensive palliative care assessment by the Research Nurses, and goals of care discussions beginning prior to administration of the first dose of phase I treatment. Patients then receive part II of the PCI comprising recommendations from the interdisciplinary team, patient educational sessions, and supportive care referrals following the first dose of phase I treatment and is completed within one month of the first treatment.
ARM II: Patients receive usual care until 12 weeks post-treatment initiation. Patients then receive both part I and II of the PCI.
After completion of study, patients are followed up for 5 years.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Arm I (early PCI)
Patients receive part I of the PCI comprising quantitative surveys, comprehensive palliative care assessment by the Research Nurses, and goals of care discussions beginning prior to administration of the first dose of phase I treatment. Patients then receive part II of the PCI comprising recommendations from the interdisciplinary team, patient educational sessions, and supportive care referrals following the first dose of phase I treatment and is completed within one month of the first treatment.
palliative care
Receive early PCI
quality-of-life assessment
Ancillary studies
survey administration
Ancillary studies
Arm II (delayed PCI)
Patients receive usual care until 12 weeks post-treatment initiation. Patients then receive both part I and II of the PCI.
palliative care
Receive delayed PCI
quality-of-life assessment
Ancillary studies
survey administration
Ancillary studies
Interventions
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palliative care
Receive early PCI
palliative care
Receive delayed PCI
quality-of-life assessment
Ancillary studies
survey administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients who have signed an informed consent for participation in Phase I clinical trials
* Able to read or understand English-this is included because the intervention and study materials (including outcome measures) are only in English
* Ability to read and/or understand the study protocol requirements, and provide written informed consent
Exclusion Criteria
21 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
City of Hope Medical Center
OTHER
Responsible Party
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Principal Investigators
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Betty Ferrell
Role: PRINCIPAL_INVESTIGATOR
City of Hope Medical Center
Locations
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City of Hope Medical Center
Duarte, California, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Hospital
Baltimore, Maryland, United States
Countries
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Other Identifiers
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NCI-2013-00731
Identifier Type: REGISTRY
Identifier Source: secondary_id
13193
Identifier Type: -
Identifier Source: org_study_id
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