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

This study has been completed.
Sponsor:
Collaborator:
Health Service of Andalucia
Information provided by:
Instituto de Salud Carlos III
ClinicalTrials.gov Identifier:
NCT00964522
First received: August 17, 2009
Last updated: June 21, 2011
Last verified: April 2010
  Purpose

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.


Condition Intervention
Breast Cancer
Other: Nurse education and care program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Randomized Trial of the Effectiveness of a Nurse Education and Care Program for Breast Cancer Patients Treated With Chemotherapy

Resource links provided by NLM:


Further study details as provided by Instituto de Salud Carlos III:

Primary Outcome Measures:
  • Use of health resources (not programmed attendance in Primary, Specialist and Emergency care or hospitalisation). [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Toxicity. [ Time Frame: one year ] [ Designated as safety issue: Yes ]
  • Quality of life. [ Time Frame: one year ] [ Designated as safety issue: Yes ]
  • Satisfaction [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Enrollment: 266
Study Start Date: January 2007
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Oncology nurse practitioner

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00964522

Locations
Spain
Oncology Unit, Hospital Universitario Puerta del Mar
Cádiz, Andalucía, Spain, 11009
Sponsors and Collaborators
Instituto de Salud Carlos III
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
  More Information

No publications provided

Responsible Party: Dr. José Manuel Baena Cañada, Hospital Universitario Puerta del Mar
ClinicalTrials.gov Identifier: NCT00964522     History of Changes
Other Study ID Numbers: PI070141
Study First Received: August 17, 2009
Last Updated: June 21, 2011
Health Authority: Spain: Ethics Committee

Keywords provided by Instituto de Salud Carlos III:
Quality of life
Breast Cancer
Nursing Care
Education
Chemotherapy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on July 23, 2014