Trial of the Effectiveness of a Nurse Education and Care Program for Breast Cancer Patients Treated With Chemotherapy
June 21, 2011 updated by: Instituto de Salud Carlos III
Randomized Trial of the Effectiveness of a Nurse Education and Care Program for Breast Cancer Patients Treated With Chemotherapy
The purpose of this study is to evaluate the effects of a nurse education and care program for patients with breast cancer, in terms of use of the health services, quality of life, satisfaction and security.
Hypothesis:
Nurse education and care program will reduce the use of health resources and will improve the toxicity, quality of life and satisfaction of the patients with breast cancer who initiate chemotherapy.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Design: randomized controlled clinical trial with non-pharmacologic intervention.
Subjects and setting of study: patients with breast cancer who initiate adjuvant, neoadjuvant or palliative chemotherapy, in the Day Unit of a University Hospital.
Interventions: random allocation of the patients in two arms according to the nursing cares.
The arm A is the one of standard education and care.
They consist of receiving programmed oral and written information by the specialist in Medical Oncology before initiating the chemotherapy treatment and before each cycle of treatment.
Also, the patients will be able to ask for information to the nurses when they need it.
Arm B is the one of experimental education and care.
They consist of receiving oral and written information by the specialist before initiating the chemotherapy treatment and before each cycle.
In addition, the patients assigned to arm B will receive programmed education and care about the chemotherapy by a nurse of the Medical Oncology service before the beginning of the treatment and in each cycle, in a specific nurse consultation.
Determinations: use of health resources (not programmed attendance in Primary, Specialist and Emergency care or hospitalisation).
Toxicity caused by the chemotherapy.
Patients who leave the chemotherapy by serious toxicity.
Quality of life measured by means of the EORTC QOL-C30 questionnaire.
Satisfaction with the received medical assistance.
Study Type
Interventional
Enrollment (Actual)
266
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Andalucía
-
Cádiz, Andalucía, Spain, 11009
- Oncology Unit, Hospital Universitario Puerta del Mar
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Patients with breast cancer who initiate adjuvant, neoadjuvant or palliative chemotherapy.
- Performance status 0-2 (ECOG).
- Outpatients.
- Normal hematopoietic, hepatic, renal, cardiac and lung functions.
- Must be able to sign the informed consent
Exclusion Criteria:
- Contraindication for chemotherapy
- Inpatients
- Simultaneously radiotherapy and endocrine therapy.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Standard care
The arm A is the one of standard education and care.
|
|
|
Active Comparator: Nurse education and care program
The arm B will receive programmed education and care about the chemotherapy by a nurse of the Medical Oncology service before the beginning of the treatment and in each cycle, in a specific nurse consultation.
|
Random allocation of the patients in two arms according to the nursing cares.
The arm A is the one of standard education and care.
They consist of receiving programmed oral and written information by the specialist before initiating the chemotherapy treatment and before each cycle of treatment.
Also, the patients will be able to ask for information to the nurses when they need it.
Arm B is the one of experimental education and care.
They consist of receiving oral and written information by the specialist before initiating the chemotherapy treatment and before each cycle.
In addition, the patients assigned to arm B will receive programmed education and care about the chemotherapy by a Oncology nurse before the beginning of the treatment and in each cycle, in a specific nurse consultation.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Use of health resources (not programmed attendance in Primary, Specialist and Emergency care or hospitalisation).
Time Frame: one year
|
one year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Toxicity.
Time Frame: one year
|
one year
|
|
Quality of life.
Time Frame: one year
|
one year
|
|
Satisfaction
Time Frame: one year
|
one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: José M. Baena-Cañada, MD; PhD, Oncology Unit, Hospital Universitario Puerta del Mar, Cádiz, Spain
- Principal Investigator: Macarena González-Muñoz, Nurse, Oncology Unit, Hospital Universitario Puerta del Mar, Cádiz, Spain
- Principal Investigator: Lourdes Solana-Grimaldi, Nurse, Oncology Unit, Hospital Universitario Puerta del Mar, Cádiz, Spain
- Principal Investigator: María D. González Piney, Nurse, Oncology Unit, Hospital Universitario Puerta del Mar, Cádiz, Spain
- Principal Investigator: Esperanza Arriola-Arellano, MD, Oncology Unit, Hospital Universitario Puerta del Mar, Cádiz, Spain
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2007
Primary Completion (Actual)
March 1, 2011
Study Completion (Actual)
March 1, 2011
Study Registration Dates
First Submitted
August 17, 2009
First Submitted That Met QC Criteria
August 24, 2009
First Posted (Estimate)
August 25, 2009
Study Record Updates
Last Update Posted (Estimate)
June 22, 2011
Last Update Submitted That Met QC Criteria
June 21, 2011
Last Verified
April 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PI070141
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