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Clinical Trial Summary

RATIONALE: Meeting with a nurse to assess symptoms and quality of life may be more effective than standard care in treating patients with pancreatic cancer.

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.


Clinical Trial Description

OBJECTIVES:

- 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. ;


Study Design

Primary Purpose: Health Services Research


Related Conditions & MeSH terms


NCT number NCT00902733
Study type Interventional
Source City of Hope Medical Center
Contact
Status Completed
Phase N/A
Start date July 2008
Completion date February 2010

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