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

This study has been completed.
National Cancer Institute (NCI)
Information provided by:
City of Hope Medical Center Identifier:
First received: May 14, 2009
Last updated: September 29, 2010
Last verified: September 2010

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.

Condition Intervention
Fatigue Nausea and Vomiting Pain Pancreatic Cancer Other: medical chart review Other: questionnaire administration Procedure: fatigue assessment and management Procedure: psychosocial assessment and care Procedure: quality-of-life assessment

Study Type: Interventional
Study Design: Primary Purpose: Health Services Research
Official Title: A Standardized Nursing Intervention Protocol for Pancreatic Cancer as a Chronic Illness

Resource links provided by NLM:

Further study details as provided by City of Hope Medical Center:

Primary Outcome Measures:
  • Quality of life, psychological distress, symptom relief, geriatric assessment outcome, and resource use at 3 months

Secondary Outcome Measures:
  • Long-term impact at 6 months

Estimated Enrollment: 125
Study Start Date: July 2008
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Detailed Description:


  • 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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Diagnosis of pancreatic cancer (all stages)


  • Admitted to City of Hope National Medical Center

    • Resides within a 30-mile radius of the medical center
  • No prior cancer


  • No prior therapy
  Contacts and Locations
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Please refer to this study by its identifier: NCT00902733

United States, California
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
Sponsors and Collaborators
City of Hope Medical Center
National Cancer Institute (NCI)
Principal Investigator: Marcia Grant, RN, DNSc, FAAN City of Hope Comprehensive Cancer Center
  More Information

Responsible Party: Marcia Grant, City of Hope Comprehensive Cancer Center Identifier: NCT00902733     History of Changes
Other Study ID Numbers: 08033
P30CA033572 ( U.S. NIH Grant/Contract )
CDR0000629414 ( Registry Identifier: NCI PDQ )
Study First Received: May 14, 2009
Last Updated: September 29, 2010

Keywords provided by City of Hope Medical Center:
nausea and vomiting
recurrent pancreatic cancer
stage I pancreatic cancer
stage II pancreatic cancer
stage III pancreatic cancer
stage IV pancreatic cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Signs and Symptoms
Signs and Symptoms, Digestive processed this record on August 16, 2017