Nurse-Provided Care or Standard Care in Treating Patients... | NCT00902733

ID	Type	Description	Link
P30CA033572	U.S. NIH Grant/Contract		View source
CHNMC-08033
CDR0000629414	Registry Identifier	NCI PDQ

Status Module

Record Verification Date

Sep 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2008

Primary Completion Date

Feb 2010Actual

Completion Date

Feb 2010Actual

First Submitted Date

May 14, 2009

First Submission Date that Met QC Criteria

May 14, 2009

First Posted Date

May 15, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 29, 2010

Last Update Posted Date

Oct 1, 2010Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

City of Hope Medical CenterOTHER

Collaborators

Name	Class
National Cancer Institute (NCI)	NIH

Description Module

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.

Conditions Module

Conditions

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

125Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
medical chart review	Other
questionnaire administration	Other
fatigue assessment and management	Procedure
psychosocial assessment and care	Procedure
quality-of-life assessment	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Quality of life, psychological distress, symptom relief, geriatric assessment outcome, and resource use at 3 months

Secondary Outcomes

Measure	Description	Time Frame
Long-term impact at 6 months

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marcia Grant, RN, DNSc, FAAN	City of Hope Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
City of Hope Comprehensive Cancer Center		Duarte	California	91010-3000	United States

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

ID	Term
D005221	Fatigue
D009325	Nausea
D014839	Vomiting
D010146	Pain
D010190	Pancreatic Neoplasms

Ancestor Terms

ID	Term
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D012817	Signs and Symptoms, Digestive
D009461	Neurologic Manifestations
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004701	Endocrine Gland Neoplasms
D004066	Digestive System Diseases
D010182	Pancreatic Diseases
D004700	Endocrine System Diseases

ID	Term
D013812	Therapeutics
D000067250	Psychiatric Rehabilitation

ID	Term
D012046	Rehabilitation
D006296	Health Services
D005159	Health Care Facilities Workforce and Services