Nurse-Provided Care or Standard Care in Treating Patients With Pancreatic Cancer
NCT ID: NCT00902733
Last Updated: 2010-10-01
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
125 participants
INTERVENTIONAL
2008-07-31
2010-02-28
Brief Summary
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PURPOSE: This clinical trial is studying nurse-provided care to see how well it works compared with standard care in treating patients with pancreatic cancer.
Detailed Description
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* To test the effects of an advanced practice nurse (APN) standardized nursing-intervention protocol (SNIP) model vs usual care on overall quality of life (QOL) and psychological distress from initial treatment to 6 months post diagnosis for patients with pancreatic cancer.
* To compare symptom control in these patients.
* To compare geriatric assessment outcomes in these patients.
* To test the effects of the SNIP intervention as compared to the usual care group on resource use by these patients.
* To test the effects of SNIP on patients' and clinicians' satisfaction with care.
* To describe the effects of SNIP on patients' management of transitions from one phase of chronic illness to another.
* To identify subgroups of these patients who benefit most from the SNIP in relation to sociodemographic characteristics, disease/treatment factors, and geriatric assessment predictors.
* To obtain feedback from clinicians regarding interpretation of findings and application to the routine care of pancreatic cancer patients.
OUTLINE: Patients are sequentially enrolled to 1 of 2 groups. Group 1 is enrolled during months 4-21 and group 2 during months 25-54.
* Group 1 (usual care): Patient questionnaires are administered at baseline and at 3 and 6 months. The clinicians' satisfaction with care is also evaluated.
* Group 2 (advanced practice nurse \[APN\] intervention): Patients are accrued by an APN. Patients meet with the APN periodically to assess their physical well-being including ambulatory care needed, care of physical symptoms (i.e., pain, fatigue, nausea and vomiting), and psychological well-being. Questionnaires are administered at baseline and at 3 and 6 months.
In both groups, questionnaires include the FACT-Hep, Memorial Symptom Assessment Scale, Psychological Distress Thermometer, Comprehensive Geriatric Assessment, and Patient Satisfaction with Intervention. Clinicians also complete questionnaires. Patients' medical charts are also reviewed.
Conditions
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Study Design
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HEALTH_SERVICES_RESEARCH
Interventions
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medical chart review
questionnaire administration
fatigue assessment and management
psychosocial assessment and care
quality-of-life assessment
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of pancreatic cancer (all stages)
PATIENT CHARACTERISTICS:
* Admitted to City of Hope National Medical Center
* Resides within a 30-mile radius of the medical center
* No prior cancer
PRIOR CONCURRENT THERAPY:
* No prior therapy
18 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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City of Hope Comprehensive Cancer Center
Principal Investigators
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Marcia Grant, RN, DNSc, FAAN
Role: PRINCIPAL_INVESTIGATOR
City of Hope Comprehensive Cancer Center
Locations
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City of Hope Comprehensive Cancer Center
Duarte, California, United States
Countries
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Other Identifiers
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08033
Identifier Type: -
Identifier Source: org_study_id
CHNMC-08033
Identifier Type: -
Identifier Source: secondary_id
CDR0000629414
Identifier Type: REGISTRY
Identifier Source: secondary_id