Nurse-Provided Care or Standard Care in Treating Patients With Pancreatic Cancer

Not Applicable

Completed

• Conditions: Pain; Pancreatic Cancer; Nausea and Vomiting; Fatigue

• Registration Number: NCT00902733
• Lead Sponsor: City of Hope Medical Center

Brief 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.

Detailed 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 Timeline

• Study Start: 2008-07
• Study First Submitted: 2009-05-14
• Study First Submitted QC: 2009-05-14
• Study First Posted: 2009-05-15
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Status Verified: 2010-09
• Last Update Submitted: 2010-09-29
• Last Update Posted: 2010-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quality of life, psychological distress, symptom relief, geriatric assessment outcome, and resource use at 3 months

Secondary Outcome Measures

Name	Time	Method
Long-term impact at 6 months

Trial Locations

Locations (1)

City of Hope Comprehensive Cancer Center; 🇺🇸 Duarte, California, United States