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

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Nurse education and care program
Sponsored by
Instituto de Salud Carlos III
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring Quality of life, Breast Cancer, Nursing Care, Education, Chemotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Oncology Unit, Hospital Universitario Puerta del Mar

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Standard care

Nurse education and care program

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Use of health resources (not programmed attendance in Primary, Specialist and Emergency care or hospitalisation).

Secondary Outcome Measures

Toxicity.
Quality of life.
Satisfaction

Full Information

First Posted
August 17, 2009
Last Updated
June 21, 2011
Sponsor
Instituto de Salud Carlos III
Collaborators
Health Service of Andalucia
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1. Study Identification

Unique Protocol Identification Number
NCT00964522
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 Type
Interventional

2. Study Status

Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Instituto de Salud Carlos III
Collaborators
Health Service of Andalucia

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Quality of life, Breast Cancer, Nursing Care, Education, Chemotherapy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
266 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard care
Arm Type
No Intervention
Arm Description
The arm A is the one of standard education and care.
Arm Title
Nurse education and care program
Arm Type
Active Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
Nurse education and care program
Other Intervention Name(s)
Oncology nurse practitioner
Intervention 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.
Primary Outcome Measure Information:
Title
Use of health resources (not programmed attendance in Primary, Specialist and Emergency care or hospitalisation).
Time Frame
one year
Secondary Outcome Measure Information:
Title
Toxicity.
Time Frame
one year
Title
Quality of life.
Time Frame
one year
Title
Satisfaction
Time Frame
one year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
José M. Baena-Cañada, MD; PhD
Organizational Affiliation
Oncology Unit, Hospital Universitario Puerta del Mar, Cádiz, Spain
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Macarena González-Muñoz, Nurse
Organizational Affiliation
Oncology Unit, Hospital Universitario Puerta del Mar, Cádiz, Spain
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lourdes Solana-Grimaldi, Nurse
Organizational Affiliation
Oncology Unit, Hospital Universitario Puerta del Mar, Cádiz, Spain
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
María D. González Piney, Nurse
Organizational Affiliation
Oncology Unit, Hospital Universitario Puerta del Mar, Cádiz, Spain
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Esperanza Arriola-Arellano, MD
Organizational Affiliation
Oncology Unit, Hospital Universitario Puerta del Mar, Cádiz, Spain
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oncology Unit, Hospital Universitario Puerta del Mar
City
Cádiz
State/Province
Andalucía
ZIP/Postal Code
11009
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
21925913
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.
Results Reference
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Trial of the Effectiveness of a Nurse Education and Care Program for Breast Cancer Patients Treated With Chemotherapy

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