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

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City of Hope

Status

Completed

Conditions

Nausea and Vomiting
Fatigue
Pain
Pancreatic Cancer

Treatments

Other: questionnaire administration
Procedure: quality-of-life assessment
Other: medical chart review
Procedure: psychosocial assessment and care
Procedure: fatigue assessment and management

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00902733
CHNMC-08033
08033
P30CA033572 (U.S. NIH Grant/Contract)
CDR0000629414 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

125 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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