Nurse-Provided Care or Standard Care in Treating Patients With Stage I, Stage II, or Stage III Breast Cancer
|ClinicalTrials.gov Identifier: NCT00903305|
Recruitment Status : Withdrawn
First Posted : May 18, 2009
Last Update Posted : February 1, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Fatigue Nausea and Vomiting Pain||Other: medical chart review Other: questionnaire administration Procedure: fatigue assessment and management Procedure: psychosocial assessment and care Procedure: quality-of-life assessment||Not Applicable|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||A Standard Nursing Intervention Protocol for Breast Cancer as a Chronic Illness|
|Study Start Date :||July 2008|
|Actual Primary Completion Date :||April 2009|
|Actual Study Completion Date :||April 2009|
Experimental: Group II (SNIP)
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.
|Other: medical chart review Other: questionnaire administration Procedure: fatigue assessment and management Procedure: psychosocial assessment and care Procedure: quality-of-life assessment|
Active Comparator: Group I (usual care intervention)
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.
|Other: medical chart review Other: questionnaire administration Procedure: fatigue assessment and management Procedure: quality-of-life assessment|
- Quality of life, psychological distress, symptom relief, geriatric assessment outcome, and resource use at 3 months
- Long-term impact at 6 months
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00903305
|Principal Investigator:||Marcia Grant, RN, DNSc, FAAN||City of Hope Comprehensive Cancer Center|