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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT00902733
First received: May 14, 2009
Last updated: September 29, 2010
Last verified: September 2010
  Purpose

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 [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Long-term impact at 6 months [ Designated as safety issue: No ]

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:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00902733

Locations
United States, California
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
Sponsors and Collaborators
City of Hope Medical Center
Investigators
Principal Investigator: Marcia Grant, RN, DNSc, FAAN Beckman Research Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Marcia Grant, City of Hope Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00902733     History of Changes
Other Study ID Numbers: 08033, P30CA033572, CHNMC-08033, CDR0000629414
Study First Received: May 14, 2009
Last Updated: September 29, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by City of Hope Medical Center:
pain
fatigue
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:
Fatigue
Nausea
Vomiting
Pancreatic Neoplasms
Signs and Symptoms
Signs and Symptoms, Digestive
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 28, 2014