Breast Cancer Clinical Trial
Official title:
A Standard Nursing Intervention Protocol for Breast Cancer as a Chronic Illness
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.
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.
;
Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
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