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Completed

NCT Number: NCT00902733

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

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.

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Key information

Conditions

Fatigue Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Nausea Nausea and Vomiting Neoplasms Neoplasms by Site Neurologic Manifestations Pain Pancreatic Cancer Pancreatic Diseases Pancreatic Neoplasms Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-3000, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

medical chart review

Other

Questionnaire Administration

Other

fatigue assessment and management

Procedure

psychosocial assessment and care

Procedure

quality-of-life assessment

Procedure

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

Sponsors and collaborators

Lead sponsor

City of Hope Medical Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

A Standardized Nursing Intervention Protocol for Pancreatic Cancer as a Chronic Illness

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
May 15, 2009
Registry last updated
Oct 1, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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