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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

266 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2011-03-31

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.

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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.

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Standard care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Nurse education and care program

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.

Group Type ACTIVE_COMPARATOR

Nurse education and care program

Intervention Type OTHER

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.

Interventions

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Nurse 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.

Intervention Type OTHER

Other Intervention Names

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Oncology nurse practitioner

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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Hospital Universitario Puerta del Mar