Breast CancerNCT00964522
Trial of the Effectiveness of a Nurse Education and Care Program for Breast Cancer Patients Treated With Chemotherapy
A study testing Nurse education and care program in people with Breast Cancer, run by Instituto de Salud Carlos III at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Nurse education and care program
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 266 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2007to Mar 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Contraindication for chemotherapy
- Inpatients
- Simultaneously radiotherapy and endocrine therapy.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Oncology Unit, Hospital Universitario Puerta del Mar
Cadiz, Andalusia, 11009
About this study
Official title: Randomized Trial of the Effectiveness of a Nurse Education and Care Program for Breast Cancer Patients Treated With Chemotherapy
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Nurse education and care program
- Keywords
- Quality of life, Breast Cancer, Nursing Care, Education, Chemotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse education and care programOther
Also called Oncology nurse practitioner
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Nurse education and care program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of health resources (not programmed attendance in Primary, Specialist and Emergency care or hospitalisation).
Measured: one year
Secondary outcomes (3)
Toxicity.
Measured: one year
Quality of life.
Measured: one year
Satisfaction
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2009 (estimated)
- Study startJan 2007
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 266 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Salud Carlos III
- Sponsor type
- Other government
- Collaborators
- Andalusian Health Service
- Investigators
- José M. Baena-Cañada, MD; PhD, Study director, Oncology Unit, Hospital Universitario Puerta del Mar, Cádiz, SpainMacarena González-Muñoz, Nurse, Principal investigator, Oncology Unit, Hospital Universitario Puerta del Mar, Cádiz, SpainLourdes Solana-Grimaldi, Nurse, Principal investigator, Oncology Unit, Hospital Universitario Puerta del Mar, Cádiz, SpainMaría D. González Piney, Nurse, Principal investigator, Oncology Unit, Hospital Universitario Puerta del Mar, Cádiz, SpainEsperanza Arriola-Arellano, MD, Principal investigator, Oncology Unit, Hospital Universitario Puerta del Mar, Cádiz, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00964522
- Sponsor's protocol ID
- PI070141
- Status last verified
- Apr 2010
- First submitted
- 17 Aug 2009
- Last updated
- 22 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21925913
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of the Effectiveness of a Nurse Education and Care Program for Breast Cancer Patients Treated With Chemotherapy
- ClinicalTrials.gov ID
- NCT00964522
- Acronym / sponsor ID
- PI070141
- Conditions
- Breast Cancer
- Keywords
- Quality of life, Breast Cancer, Nursing Care, Education, Chemotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 266 participants (actual)
- Lead sponsor
- Instituto de Salud Carlos IIIOther government
- Collaborators
- Andalusian Health Service
- Study start
- Jan 2007
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 25 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard care | No intervention | –The arm A is the one of standard education and care. |
| Nurse education and care program | Active comparator | Other: Nurse education and care programThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Contraindication for chemotherapy
- Inpatients
- Simultaneously radiotherapy and endocrine therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nurse education and care programAlso: Oncology nurse practitionerRandom 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. | Other | Nurse education and care program |
Primary outcome
Use of health resources (not programmed attendance in Primary, Specialist and Emergency care or hospitalisation).
Time frame: one year
3 secondary outcomes
Toxicity.
Time frame: one year
Quality of life.
Time frame: one year
Satisfaction
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2011.
- Derived from this study: PubMed 21925913Baena-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
José M. Baena-Cañada, MD; PhD study director
Oncology Unit, Hospital Universitario Puerta del Mar, Cádiz, Spain
Macarena González-Muñoz, Nurse principal investigator
Oncology Unit, Hospital Universitario Puerta del Mar, Cádiz, Spain
Lourdes Solana-Grimaldi, Nurse principal investigator
Oncology Unit, Hospital Universitario Puerta del Mar, Cádiz, Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse education and care program in people with Breast Cancer, run by Instituto de Salud Carlos III at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Use of health resources (not programmed attendance in Primary, Specialist and Emergency care or hospitalisation). (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00964522, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2011.