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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00964522
• Other study ID #: PI070141
• Status: Completed
• Phase: N/A
• First received: August 17, 2009
• Last updated: June 21, 2011
• Start date: January 2007
• Est. completion date: March 2011

Study information

• Verified date: April 2010
• Source: Instituto de Salud Carlos III
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 266
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Spain	Oncology Unit, Hospital Universitario Puerta del Mar	Cádiz	Andalucía

Sponsors (2)

Lead Sponsor	Collaborator
Instituto de Salud Carlos III	Health Service of Andalucia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Use of health resources (not programmed attendance in Primary, Specialist and Emergency care or hospitalisation).		one year	Yes
Secondary	Toxicity.		one year	Yes
Secondary	Quality of life.		one year	Yes
Secondary	Satisfaction		one year	Yes