NCT00964522

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
266

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Jan 2007

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

August 17, 2009

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 25, 2009

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

June 22, 2011

Status Verified

April 1, 2010

Enrollment Period

4.2 years

First QC Date

August 17, 2009

Last Update Submit

June 21, 2011

Conditions

Breast Cancer

Keywords

Quality of lifeBreast CancerNursing CareEducationChemotherapy

Outcome Measures

Primary Outcomes (1)

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

    one year

Secondary Outcomes (3)

  • Toxicity.

    one year

  • Quality of life.

    one year

  • Satisfaction

    one year

Study Arms (2)

Standard care

NO INTERVENTION

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

Nurse education and care program

ACTIVE COMPARATOR

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

Interventions

Nurse education and care programOTHER

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.

Also known as: Oncology nurse practitioner
Nurse education and care program

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Contraindication for chemotherapy
  • Inpatients
  • Simultaneously radiotherapy and endocrine therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oncology Unit, Hospital Universitario Puerta del Mar

Cadiz, Andalusia, 11009, Spain

Location

Related Publications (1)

  • 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.

    PMID: 21925913DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • José M. Baena-Cañada, MD; PhD

    Oncology Unit, Hospital Universitario Puerta del Mar, Cádiz, Spain

    STUDY DIRECTOR

  • Macarena González-Muñoz, Nurse

    Oncology Unit, Hospital Universitario Puerta del Mar, Cádiz, Spain

    PRINCIPAL INVESTIGATOR

  • Lourdes Solana-Grimaldi, Nurse

    Oncology Unit, Hospital Universitario Puerta del Mar, Cádiz, Spain

    PRINCIPAL INVESTIGATOR

  • María D. González Piney, Nurse

    Oncology Unit, Hospital Universitario Puerta del Mar, Cádiz, Spain

    PRINCIPAL INVESTIGATOR

  • Esperanza Arriola-Arellano, MD

    Oncology Unit, Hospital Universitario Puerta del Mar, Cádiz, Spain

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

August 17, 2009

First Posted

August 25, 2009

Study Start

January 1, 2007

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

June 22, 2011

Record last verified: 2010-04

Locations

ES(1)