Nurse-Provided Care or Standard Care in Treating Patients With Stage I, Stage II, or Stage III Breast Cancer

Breast Cancer Clinical Trial

Official title:

A Standard Nursing Intervention Protocol for Breast Cancer as a Chronic Illness

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00903305
• Other study ID #: CDR0000629408
• Secondary ID: P30CA033572CHNMC
• Status: Withdrawn
• Phase: N/A
• First received: May 15, 2009
• Last updated: January 30, 2013
• Start date: July 2008
• Est. completion date: April 2009

Study information

• Verified date: January 2013
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Meeting with a nurse to assess symptoms and quality of life may be more effective than standard care in treating patients with breast cancer.

PURPOSE: This clinical trial is studying nurse-provided care to see how well it works compared with standard care in treating patients with stage I, stage II, or stage III breast cancer.

Description:

OBJECTIVES:

• To compare the effects of an advanced practice nurse, standardized nursing intervention protocol (SNIP) model vs usual care on overall quality of life and psychological distress of patients with stage I-III breast cancer, from initial treatment to 6 months post diagnosis.

• To compare symptom control in these two groups.

• To compare geriatric assessment outcomes in these two groups.

• 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 breast cancer patients.

OUTLINE: Patients are enrolled sequentially to 1 of 2 groups. Group 1 is enrolled during months 4-21 and group 2 is enrolled 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-Breast, 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Diagnosis of stage I, II, or III breast cancer

• Admitted to City of Hope National Medical Center

• Resides within a 30-mile radius of the medical center

• Hormone receptor status not specified

PATIENT CHARACTERISTICS:

• Menopausal status not specified

• No prior cancer

PRIOR CONCURRENT THERAPY:

• Not specified

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Fatigue
• Nausea and Vomiting
• Pain

Intervention

Other:
• medical chart review

• questionnaire administration

Procedure:
• fatigue assessment and management

• psychosocial assessment and care

• quality-of-life assessment

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
City of Hope Medical Center	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life, psychological distress, symptom relief, geriatric assessment outcome, and resource use at 3 months			No
Primary	Long-term impact at 6 months			No