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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Other: Nurse education and care program


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard care<br>The arm A is the one of standard education and care. | |
| Active Comparator: Nurse education and care program<br>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. | Other: Nurse education and care program<br>* 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.<br>* Other names: Oncology nurse practitioner;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of health resources (not programmed attendance in Primary, Specialist and Emergency care or hospitalisation). |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity. |  | one year | 
| Quality of life. |  | one year | 
| Satisfaction |  | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Quality of life, Breast Cancer, Nursing Care, Education, Chemotherapy