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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00902733
Recruitment Status : Completed
First Posted : May 15, 2009
Last Update Posted : October 1, 2010
National Cancer Institute (NCI)
Information provided by:
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.

Condition or disease Intervention/treatment Phase
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 Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 125 participants
Primary Purpose: Health Services Research
Official Title: A Standardized Nursing Intervention Protocol for Pancreatic Cancer as a Chronic Illness
Study Start Date : July 2008
Actual Primary Completion Date : February 2010
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Secondary Outcome Measures :
  1. Long-term impact at 6 months

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

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 )
First Posted: May 15, 2009    Key Record Dates
Last Update Posted: October 1, 2010
Last Verified: September 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