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

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Other: Nurse education and care program

• Registration Number: NCT00964522
• Lead Sponsor: Instituto de Salud Carlos III

Brief 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.

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 Timeline

• Study Start: 2007-01
• Study First Submitted: 2009-08-17
• Study First Submitted QC: 2009-08-24
• Study First Posted: 2009-08-25
• Status Verified: 2010-04
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Last Update Submitted: 2011-06-21
• Last Update Posted: 2011-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 266

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nurse education and care program	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.

Primary Outcome Measures

Name	Time	Method
Use of health resources (not programmed attendance in Primary, Specialist and Emergency care or hospitalisation).	one year

Secondary Outcome Measures

Name	Time	Method
Toxicity.	one year
Quality of life.	one year
Satisfaction	one year

Trial Locations

Locations (1)

Oncology Unit, Hospital Universitario Puerta del Mar; 🇪🇸 Cádiz, Andalucía, Spain