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

City of Hope

Status: Withdrawn

Conditions: Breast Cancer; Nausea and Vomiting; Fatigue; Pain

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00903305

CHNMC-08031

P30CA033572 (U.S. NIH Grant/Contract)

CDR0000629408

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 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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

0 participants in 2 patient groups

Group II (SNIP)

Experimental group

Description:

Patients undergo SNIP comprising four visits over 2 months and four monthly telephone calls from the APN. The APN will provide 24 hour access during the study. Patients complete questionnaires about satisfaction with care, perceived preparedness with self-care, and helpfulness of patient teaching at baseline, 3 months and 6 months.

Treatment:

Procedure: fatigue assessment and management

Other: questionnaire administration

Other: medical chart review

Procedure: quality-of-life assessment

Procedure: psychosocial assessment and care

Group I (usual care intervention)

Active Comparator group

Description:

Patients undergo usual care and complete questionnaires about satisfaction with care, perceived preparedness with self-care, and helpfulness of patient teaching at baseline, 3 months and 6 months.

Treatment:

Procedure: fatigue assessment and management

Other: questionnaire administration

Other: medical chart review

Procedure: quality-of-life assessment