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

Carlos III Health Institute (ISCIII)

Status: Completed

Conditions: Breast Cancer

Treatments: Other: Nurse education and care program

Study type: Interventional

Funder types: Other

Identifiers

NCT00964522

PI070141

Details and patient eligibility

About

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.

Full 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.

Enrollment: 266 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

266 participants in 2 patient groups

Standard care

No Intervention group

Description:

The arm A is the one of standard education and care.

Nurse education and care program

Active Comparator group

Description:

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.

Treatment:

Other: Nurse education and care program