Palliative Care Intervention in Patients With Solid Tumors Participating in Phase I Clinical Trials
NCT ID: NCT01612598
Last Updated: 2014-01-31
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
16 participants
INTERVENTIONAL
2012-07-31
2014-01-31
Brief Summary
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Detailed Description
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I. Describe the feasibility of implementing a PCI for patients on phase I clinical trials (study accrual and retention).
II. Describe the initial impact of a PCI on key patient outcome measures (quality of life \[QOL\], psychological distress, satisfaction with communication, symptom intensity, symptom distress, and patient satisfaction) over time.
OUTLINE:
PCI PART I: Patients undergo comprehensive palliative care (PC) assessment based on baseline data and complete goals of care discussion.
PCI PART II: Following the first dose of phase I investigational treatment, patients meet with the interdisciplinary team (IDT), where PC recommendations are made. This is followed by two patient educational sessions that will cover QOL-related domains, including physical, social, emotional, and spiritual well-being. Supportive care referrals are made based on IDT recommendations.
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Supportive Care (PCI)
PCI PART I: Patients undergo comprehensive PC assessment based on baseline data and complete goals of care discussion.
PCI PART II: Following the first dose of phase I investigational treatment, patients meet with the IDT, where PC recommendations are made. This is followed by two patient educational sessions that will cover QOL-related domains, including physical, social, emotional, and spiritual well-being. Supportive care referrals are made based on IDT recommendations.
counseling intervention
Undergo PCI
quality-of-life assessment
Ancillary studies
questionnaire administration
Ancillary studies
educational intervention
Undergo PCI
Interventions
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counseling intervention
Undergo PCI
quality-of-life assessment
Ancillary studies
questionnaire administration
Ancillary studies
educational intervention
Undergo PCI
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Able to read or understand 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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References
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Ferrell B, Chung V, Hughes MT, Koczywas M, Azad NS, Ruel NH, Knight L, Cooper RS, Smith TJ. A Palliative Care Intervention for Patients on Phase 1 Studies. J Palliat Med. 2021 Jun;24(6):846-856. doi: 10.1089/jpm.2020.0597. Epub 2020 Oct 27.
Other Identifiers
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NCI-2012-00887
Identifier Type: REGISTRY
Identifier Source: secondary_id
12123
Identifier Type: -
Identifier Source: org_study_id