Breast Cancer, Fatigue, Nausea and Vomiting, Pain
Conditions
Keywords
pain, fatigue, nausea and vomiting, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer
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 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.
Detailed 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.
Interventions
OTHERmedical chart review
OTHERquestionnaire administration
PROCEDUREfatigue assessment and management
PROCEDUREpsychosocial assessment and care
PROCEDUREquality-of-life assessment
Sponsors
National Cancer Institute (NCI)
City of Hope Medical Center
Study design
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quality of life, psychological distress, symptom relief, geriatric assessment outcome, and resource use at 3 months | — |
| Long-term impact at 6 months | — |
Outcome results
None listed