Back to resultsNurse-Provided Care or Standard Care in Treating Patients With Pancreatic Cancer
Primary Purpose
Fatigue, Nausea and Vomiting, Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
medical chart review
questionnaire administration
fatigue assessment and management
psychosocial assessment and care
quality-of-life assessment
Sponsored by
About this trial
This is an interventional health services research trial for Fatigue focused on measuring pain, fatigue, nausea and vomiting, recurrent pancreatic cancer, stage I pancreatic cancer, stage II pancreatic cancer, stage III pancreatic cancer, stage IV pancreatic cancer
Eligibility 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
Sites / Locations
- City of Hope Comprehensive Cancer Center
Outcomes
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
Full Information
NCT ID
NCT00902733
First Posted
May 14, 2009
Last Updated
September 29, 2010
Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00902733
Brief Title
Nurse-Provided Care or Standard Care in Treating Patients With Pancreatic Cancer
Official Title
A Standardized Nursing Intervention Protocol for Pancreatic Cancer as a Chronic Illness
Study Type
Interventional
2. Study Status
Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue, Nausea and Vomiting, Pain, Pancreatic Cancer
Keywords
pain, fatigue, nausea and vomiting, recurrent pancreatic cancer, stage I pancreatic cancer, stage II pancreatic cancer, stage III pancreatic cancer, stage IV pancreatic cancer
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Enrollment
125 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
medical chart review
Intervention Type
Other
Intervention Name(s)
questionnaire administration
Intervention Type
Procedure
Intervention Name(s)
fatigue assessment and management
Intervention Type
Procedure
Intervention Name(s)
psychosocial assessment and care
Intervention Type
Procedure
Intervention Name(s)
quality-of-life assessment
Primary Outcome Measure Information:
Title
Quality of life, psychological distress, symptom relief, geriatric assessment outcome, and resource use at 3 months
Secondary Outcome Measure Information:
Title
Long-term impact at 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcia Grant, RN, DNSc, FAAN
Organizational Affiliation
City of Hope Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope Comprehensive Cancer Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010-3000
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Nurse-Provided Care or Standard Care in Treating Patients With Pancreatic Cancer
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