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

Primary Purpose

Breast Cancer, Fatigue, Nausea and Vomiting

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
medical chart review
questionnaire administration
fatigue assessment and management
psychosocial assessment and care
quality-of-life assessment
Sponsored by
City of Hope Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Breast Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Group II (SNIP)

    Group I (usual care intervention)

    Arm 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.

    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.

    Outcomes

    Primary Outcome Measures

    Quality of life, psychological distress, symptom relief, geriatric assessment outcome, and resource use at 3 months
    Long-term impact at 6 months

    Secondary Outcome Measures

    Full Information

    First Posted
    May 15, 2009
    Last Updated
    January 30, 2013
    Sponsor
    City of Hope Medical Center
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00903305
    Brief Title
    Nurse-Provided Care or Standard Care in Treating Patients With Stage I, Stage II, or Stage III Breast Cancer
    Official Title
    A Standard Nursing Intervention Protocol for Breast Cancer as a Chronic Illness
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2013
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    July 2008 (undefined)
    Primary Completion Date
    April 2009 (Actual)
    Study Completion Date
    April 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    City of Hope Medical Center
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Cancer, Fatigue, Nausea and Vomiting, Pain
    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

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group II (SNIP)
    Arm Type
    Experimental
    Arm 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.
    Arm Title
    Group I (usual care intervention)
    Arm Type
    Active Comparator
    Arm 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.
    Intervention Type
    Other
    Intervention Name(s)
    medical chart review
    Intervention Type
    Other
    Intervention Name(s)
    questionnaire administration
    Intervention Type
    Procedure
    Intervention Name(s)
    fatigue assessment and management
    Intervention Type
    Procedure
    Intervention Name(s)
    psychosocial assessment and care
    Intervention Type
    Procedure
    Intervention Name(s)
    quality-of-life assessment
    Primary Outcome Measure Information:
    Title
    Quality of life, psychological distress, symptom relief, geriatric assessment outcome, and resource use at 3 months
    Title
    Long-term impact at 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Marcia Grant, RN, DNSc, FAAN
    Organizational Affiliation
    City of Hope Comprehensive Cancer Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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