Randomized Trial of the Effectiveness of a Nurse Education and Care Program for Breast Cancer Patients Treated With Chemotherapy
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.
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Use of health resources (not programmed attendance in Primary, Specialist and Emergency care or hospitalisation).
José M. Baena-Cañada, MD; PhD
Oncology Unit, Hospital Universitario Puerta del Mar, Cádiz, Spain
Spain: Ethics Committee