CClinicalTrials.gg
CompletedNCT00902733Updated Oct 1, 2010

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

An interventional study of medical chart review and questionnaire administration in Fatigue, Nausea and Vomiting and Pain, sponsored by City of Hope Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-10-01.

Sponsored by City of Hope Medical Center · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
125
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • 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
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In context

Pancreatic Neoplasms

3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.

This study's planned enrollment of 125 is above the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.

Browse Pancreatic Neoplasms studies →

Lead sponsor

City of Hope Medical Center is the lead sponsor of 670 studies on the registry; 181 are open to participants now.

Of its 30 completed or terminated interventional studies of FDA-regulated products, 12 (40%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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
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Study design

Phase
Not applicable
Primary purpose
Health services research
Enrollment
125 participants (estimated)

Interventions

  • Othermedical chart review
  • Otherquestionnaire administration
  • Procedurefatigue assessment and management
  • Procedurepsychosocial assessment and care
  • Procedurequality-of-life assessment
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What researchers measure

Primary outcomes

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

Secondary outcomes

  1. Long-term impact at 6 months

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Study locations

1 site
  • City of Hope Comprehensive Cancer Center
    Duarte, California 91010-3000, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 1, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00902733
Lead sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
First posted
May 15, 2009
Start date
Jul 2008
Primary completion
Feb 2010
Completion
Feb 2010
Last update
Oct 1, 2010

Study contacts

Marcia Grant, RN, DNSc, FAAN
principal investigator · City of Hope Comprehensive Cancer Center
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2010. You cannot join it, but the record below documents what was studied.

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