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

  • Spain
    • 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.
Other: Nurse education and care program
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:
  • Oncology nurse practitioner

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

Instituto de Salud Carlos III

Collaborators

Health Service of Andalucia

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.

General Publications

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

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI070141

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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