Nurse-Provided Care or Standard Care in Treating Patients... | NCT00903305

NCT00903305

ID	Type	Description	Link
P30CA033572	U.S. NIH Grant/Contract		View source
CHNMC-08031

Status Module

Name	Class
National Cancer Institute (NCI)	NIH

Description Module

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.

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group II (SNIP)	Experimental	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
Group I (usual care intervention)	Active Comparator	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

Name	Type	Description	Arm Group Labels	Other Names
medical chart review	Other		Group I (usual care intervention) Group II (SNIP)
questionnaire administration

Outcomes Module

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Marcia Grant, RN, DNSc, FAAN	City of Hope Medical Center	Principal Investigator

ID	Term
D001943	Breast Neoplasms
D005221	Fatigue
D009325	Nausea
D014839	Vomiting
D010146	Pain

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D012817	Signs and Symptoms, Digestive
D009461	Neurologic Manifestations

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

ID	Term
D013812	Therapeutics
D000067250	Psychiatric Rehabilitation

ID	Term
D012046	Rehabilitation
D006296	Health Services
D005159	Health Care Facilities Workforce and Services