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

Pain Clinical Trial

Official title:

A Standardized Nursing Intervention Protocol for Pancreatic Cancer as a Chronic Illness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00902733
• Other study ID #: 08033
• Secondary ID: P30CA033572CHNMC
• Status: Completed
• Phase: N/A
• First received: May 14, 2009
• Last updated: September 29, 2010
• Start date: July 2008
• Est. completion date: February 2010

Study information

• Verified date: September 2010
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• 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

Study Design

Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Fatigue
• Nausea and Vomiting
• Pain
• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Other:
• medical chart review

• questionnaire administration

Procedure:
• fatigue assessment and management

• psychosocial assessment and care

• quality-of-life assessment

Locations

Country	Name	City	State
United States	City of Hope Comprehensive Cancer Center	Duarte	California

Sponsors (2)

Lead Sponsor	Collaborator
City of Hope Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life, psychological distress, symptom relief, geriatric assessment outcome, and resource use at 3 months			No
Secondary	Long-term impact at 6 months			No