Palliative Care in Improving Quality of Life and Symptoms in Patients With Stage III-IV Pancreatic or Ovarian Cancer
NCT ID: NCT01927393
Last Updated: 2014-12-23
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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WITHDRAWN
NA
INTERVENTIONAL
2014-12-31
Brief Summary
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Detailed Description
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I. Test the effects of a concurrent palliative care planning intervention (PCPI) on overall quality of life (QOL) and symptom burden.
II. Test the effects of a concurrent PCPI on anxiety and depression. III. Test the effects of a concurrent PCPI on overall survival. IV. Test the effects of a concurrent PCPI on health care resource use.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo a comprehensive physical, psychological, social, and spiritual palliative care assessment. Patients also receive a workbook that covers physical and psychological well-being and social and spiritual well-being, delivered over 2 educational sessions.
ARM II: Patients receive standard care plus attention comprising two telephone contacts.
After completion of study, patients are followed up at 1, 3, and 6 months.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Arm I (PCPI)
Patients undergo a comprehensive physical, psychological, social, and spiritual palliative care assessment. Patients also receive a workbook that covers physical and psychological well-being and social and spiritual well-being, delivered over 2 educational sessions.
palliative care
Receive PCPI
educational intervention
Receive education sessions
quality-of-life assessment
Ancillary studies
questionnaire administration
Ancillary studies
Arm II (standard care plus attention control)
Patients receive standard care plus attention comprising two telephone contacts.
quality-of-life assessment
Ancillary studies
questionnaire administration
Ancillary studies
telephone-based intervention
Receive telephone contacts
Interventions
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palliative care
Receive PCPI
educational intervention
Receive education sessions
quality-of-life assessment
Ancillary studies
questionnaire administration
Ancillary studies
telephone-based intervention
Receive telephone contacts
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Confirmed stage III or IV disease
* Patients who are within one year from initial diagnosis
* Able to read or understand English-this is included because most of the patient-reported outcome measures are not validated in linguistically diverse populations; the intent is to adapt and test the intervention in a future study with linguistically diverse populations
* Ability to read and/or understand the study protocol requirements, and provide written informed consent
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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Virginia Sun
Role: PRINCIPAL_INVESTIGATOR
City of Hope Medical Center
Locations
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City of Hope Medical Center
Duarte, California, United States
Countries
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Other Identifiers
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NCI-2013-01629
Identifier Type: REGISTRY
Identifier Source: secondary_id
13270
Identifier Type: OTHER
Identifier Source: secondary_id
13270
Identifier Type: -
Identifier Source: org_study_id