Breast Cancer
Conditions
Keywords
Quality of life, Breast Cancer, Nursing Care, Education, Chemotherapy
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.
Interventions
OTHERNurse 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
Health Service of Andalucia
Instituto de Salud Carlos III
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Use of health resources (not programmed attendance in Primary, Specialist and Emergency care or hospitalisation). | one year |
Secondary
| Measure | Time frame |
|---|---|
| Toxicity. | one year |
| Quality of life. | one year |
| Satisfaction | one year |
Countries
Spain
Outcome results
None listed