Trials / Withdrawn
WithdrawnNCT00903305
Nurse-Provided Care or Standard Care in Treating Patients With Stage I, Stage II, or Stage III Breast Cancer
A Standard Nursing Intervention Protocol for Breast Cancer as a Chronic Illness
- Status
- Withdrawn
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- City of Hope Medical Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | medical chart review | |
| OTHER | questionnaire administration | |
| PROCEDURE | fatigue assessment and management | |
| PROCEDURE | psychosocial assessment and care | |
| PROCEDURE | quality-of-life assessment |
Timeline
- Start date
- 2008-07-01
- Primary completion
- 2009-04-01
- Completion
- 2009-04-01
- First posted
- 2009-05-18
- Last updated
- 2013-02-01
Source: ClinicalTrials.gov record NCT00903305. Inclusion in this directory is not an endorsement.