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

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

Sponsors

Lead Sponsor: Instituto de Salud Carlos III

Collaborator: Health Service of Andalucia

Source Instituto de Salud Carlos III
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.

Overall Status Completed
Start Date January 2007
Completion Date March 2011
Primary Completion Date March 2011
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Use of health resources (not programmed attendance in Primary, Specialist and Emergency care or hospitalisation). one year
Secondary Outcome
Measure Time Frame
Toxicity. one year
Quality of life. one year
Satisfaction one year
Enrollment 266
Condition
Intervention

Intervention Type: Other

Intervention Name: Nurse education and care program

Description: 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.

Arm Group Label: Nurse education and care program

Other Name: Oncology nurse practitioner

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.

Gender: Female

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Location
Facility: Oncology Unit, Hospital Universitario Puerta del Mar
Location Countries

Spain

Verification Date

April 2010

Responsible Party

Name Title: Dr. José Manuel Baena Cañada

Organization: Hospital Universitario Puerta del Mar

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Standard care

Type: No Intervention

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

Label: Nurse education and care program

Type: Active Comparator

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.

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Supportive Care

Masking: None (Open Label)

Source: ClinicalTrials.gov