Nurse-Provided Care or Standard Care in Treating Patients With Pancreatic Cancer
|ClinicalTrials.gov Identifier: NCT00902733|
Recruitment Status : Completed
First Posted : May 15, 2009
Last Update Posted : October 1, 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 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|
- 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|
- Quality of life, psychological distress, symptom relief, geriatric assessment outcome, and resource use at 3 months
- Long-term impact at 6 months
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00902733
|United States, California|
|City of Hope Comprehensive Cancer Center|
|Duarte, California, United States, 91010-3000|
|Principal Investigator:||Marcia Grant, RN, DNSc, FAAN||City of Hope Comprehensive Cancer Center|