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Trial of the Effectiveness of a Nurse Education and Care Program for Breast Cancer Patients Treated With Chemotherapy

NCT00964522 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 266

Last updated 2011-06-22

No results posted yet for this study

Summary

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Health Service of Andalucia

    collaborator OTHER_GOV

  • Instituto de Salud Carlos III

    lead OTHER_GOV

Principal Investigators

  • José M. Baena-Cañada, MD; PhD · Oncology Unit, Hospital Universitario Puerta del Mar, Cádiz, Spain

  • Macarena González-Muñoz, Nurse · Oncology Unit, Hospital Universitario Puerta del Mar, Cádiz, Spain

  • Lourdes Solana-Grimaldi, Nurse · Oncology Unit, Hospital Universitario Puerta del Mar, Cádiz, Spain

  • María D. González Piney, Nurse · Oncology Unit, Hospital Universitario Puerta del Mar, Cádiz, Spain

  • Esperanza Arriola-Arellano, MD · Oncology Unit, Hospital Universitario Puerta del Mar, Cádiz, Spain

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2011-03-31
Completion
2011-03-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00964522 on ClinicalTrials.gov