Spots Global Cancer Trial Database for Trial of the Effectiveness of a Nurse Education and Care Program for Breast Cancer Patients Treated With Chemotherapy
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Trial Identification
Brief Title: 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 ID: NCT00964522
Conditions
Interventions
Study Description
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
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Oncology Unit, Hospital Universitario Puerta del Mar, Cádiz, Andalucía, Spain
Contact Details
Name: José M. Baena-Cañada, MD; PhD
Affiliation: Oncology Unit, Hospital Universitario Puerta del Mar, Cádiz, Spain
Role: STUDY_DIRECTOR
Name: Macarena González-Muñoz, Nurse
Affiliation: Oncology Unit, Hospital Universitario Puerta del Mar, Cádiz, Spain
Role: PRINCIPAL_INVESTIGATOR
Name: Lourdes Solana-Grimaldi, Nurse
Affiliation: Oncology Unit, Hospital Universitario Puerta del Mar, Cádiz, Spain
Role: PRINCIPAL_INVESTIGATOR
Name: María D. González Piney, Nurse
Affiliation: Oncology Unit, Hospital Universitario Puerta del Mar, Cádiz, Spain
Role: PRINCIPAL_INVESTIGATOR
Name: Esperanza Arriola-Arellano, MD
Affiliation: Oncology Unit, Hospital Universitario Puerta del Mar, Cádiz, Spain
Role: PRINCIPAL_INVESTIGATOR
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