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A Standard Nursing Intervention Protocol for Breast Cancer as a Chronic Illness

18 Years
Not Enrolling
Breast Cancer, Fatigue, Nausea and Vomiting, Pain

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Trial Information

A Standard Nursing Intervention Protocol for Breast Cancer as a Chronic Illness


- 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

- 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.

Inclusion Criteria


- 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


- Menopausal status not specified

- No prior cancer


- Not specified

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Outcome Measure:

Quality of life, psychological distress, symptom relief, geriatric assessment outcome, and resource use at 3 months

Safety Issue:


Principal Investigator

Marcia Grant, RN, DNSc, FAAN

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beckman Research Institute


United States: Federal Government

Study ID:




Start Date:

July 2008

Completion Date:

April 2009

Related Keywords:

  • Breast Cancer
  • Fatigue
  • Nausea and Vomiting
  • Pain
  • 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
  • Breast Neoplasms
  • Fatigue
  • Nausea
  • Vomiting