Clinical trial NCT00964522: Trial of the Effectiveness of a Nurse Education and Care Program for Breast Cancer Patients Treated With Chemotherapy
Official title: Randomized Trial of the Effectiveness of a Nurse Education and Care Program for Breast Cancer Patients Treated With Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Quality of life
Breast Cancer
Nursing Care
Education
Chemotherapy
Lead sponsor: Instituto de Salud Carlos III
Sponsor class: OTHER_GOV
Collaborators: name: Health Service of Andalucia
First posted: 2009-08-25
Enrollment: 266
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Use of health resources (not programmed attendance in Primary, Specialist and Emergency care or hospitalisation).
timeFrame: one year
Secondary outcomes:
measure: Toxicity.
timeFrame: one year
measure: Quality of life.
timeFrame: one year
measure: Satisfaction
timeFrame: one year
Other outcomes:
Locations:
city: Cádiz
country: Spain
facility: Oncology Unit, Hospital Universitario Puerta del Mar
state: Andalucía
Study officials:
affiliation: Oncology Unit, Hospital Universitario Puerta del Mar, Cádiz, Spain
name: José M. Baena-Cañada, MD; PhD
role: STUDY_DIRECTOR
affiliation: Oncology Unit, Hospital Universitario Puerta del Mar, Cádiz, Spain
name: Macarena González-Muñoz, Nurse
role: PRINCIPAL_INVESTIGATOR
affiliation: Oncology Unit, Hospital Universitario Puerta del Mar, Cádiz, Spain
name: Lourdes Solana-Grimaldi, Nurse
role: PRINCIPAL_INVESTIGATOR
affiliation: Oncology Unit, Hospital Universitario Puerta del Mar, Cádiz, Spain
name: María D. González Piney, Nurse
role: PRINCIPAL_INVESTIGATOR
affiliation: Oncology Unit, Hospital Universitario Puerta del Mar, Cádiz, Spain
name: Esperanza Arriola-Arellano, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Baena-Canada JM, Estalella-Mendoza S, Gonzalez-Guerrero M, Exposito-Alvarez I, Rosado-Varela P, Benitez-Rodriguez E. [Influence of clinical and biographical factors on the quality of life of women with breast cancer receiving adjuvant chemotherapy]. Rev Calid Asist. 2011 Sep-Oct;26(5):299-305. doi: 10.1016/j.cali.2011.04.005. Epub 2011 Sep 16. Spanish.