Metastatic Breast CancerNCT02051010
ABC Survey - do we Meet the Needs of Patients With Advanced Breast Cancer?
An observational study of Metastatic Breast Cancer, run by Cancer Trials Ireland at 13 sites in Ireland.
Trial summary
The study will follow a descriptive design involving a survey. Data collection will involve paper based questionnaires. The questionnaires have been developed in conjunction with breast cancer support groups associated with the Irish Cancer Society and patients. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Metastatic Breast Cancer
- How many people
- 500 participants
- Where
- 13 sitesIreland
- Study dates
- May 2013to Mar 2015
- Phase
- Observational
- 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
Study population: All patients must have metastatic breast cancer
Who may be able to join
- Signed written informed consent
- Clinical diagnosis of MBC
- Female aged 18 years or older
- Able to complete the questionnaires independently
Who cannot join
- Any patient who does not meet the above mentioned inclusion criteria.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Ireland13 sites
Bon Secours Hospital
Cork
Cork University Hospital
Cork
South Infirmary - Victoria University Hospital
Cork
Letterkenny General Hospital
Donegal
Saint Vincent Universtiy Hospital
Dublin, 4
Mater Misericordiae University Hospital and Mater Private Hospital
Dublin, 7
Saint James's Hospital
Dublin, 8
Beaumont Hospital
Dublin
Galway University Hospital
Galway
Kerry General Hospital
Kerry
Midwestern Regional Hospital
Limerick
Sligo General Hospital
Sligo
Waterford Regional Hospital
Waterford
About this study
Official title: ABC Survey: Are we Meeting the Needs of Patients With Advanced Breast Cancer (ABC) in Ireland? A Nationwide Survey
The study will follow a descriptive design involving a survey. Data collection will involve paper based questionnaires. The questionnaires have been developed in conjunction with breast cancer support groups associated with the Irish Cancer Society and patients.
Read the detailed description
The purpose of the study is to identify and categorise the need of Metastatic Breast Cancer (MBC) patients in Ireland with particular focus on; quality of life, symptom burden and access to and value of support available.
The study also aims to evaluate future service developments that will provide support to these patients.
- Conditions
- Metastatic Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Metastatic Breast Cancer | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Needs of MBC patients in Ireland
The needs of MBC patients to be identified and categorised with particular focus on; quality of life, symptom burden and access to and value of available support
Measured: Following analysis of the questionnaires completed by the patients, estimated 24 months
Secondary outcomes (1)
Future service developments
Evaluation of future service developments that will provide support to these patients
Measured: Following analysis of the questionnaires completed by patients, estimated 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2014 (estimated)
- Study startMay 2013
- Primary completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cancer Trials Ireland
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02051010
- Sponsor's protocol ID
- ICORG 13-01
- Status last verified
- Mar 2015
- First submitted
- 24 Jan 2014
- Last updated
- 30 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ABC Survey: Are we Meeting the Needs of Patients With Advanced Breast Cancer (ABC) in Ireland? A Nationwide Survey
- ClinicalTrials.gov ID
- NCT02051010
- Acronym / sponsor ID
- ICORG 13-01
- Conditions
- Metastatic Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Cancer Trials IrelandResearch network
- Study start
- May 2013
- Primary completion
- Mar 2015 (actual)
- First posted
- 31 Jan 2014 (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 study will follow a descriptive design involving a survey. Data collection will involve paper based questionnaires. The questionnaires have been developed in conjunction with breast cancer support groups associated with the Irish Cancer Society and patients.
Detailed description
The purpose of the study is to identify and categorise the need of Metastatic Breast Cancer (MBC) patients in Ireland with particular focus on; quality of life, symptom burden and access to and value of support available.
The study also aims to evaluate future service developments that will provide support to these patients.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metastatic Breast Cancer | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients must have metastatic breast cancer
Key inclusion criteria (4 listed)
- Signed written informed consent
- Clinical diagnosis of MBC
- Female aged 18 years or older
- Able to complete the questionnaires independently
Key exclusion criteria (1 listed)
- Any patient who does not meet the above mentioned inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Needs of MBC patients in Ireland
Time frame: Following analysis of the questionnaires completed by the patients, estimated 24 months
The needs of MBC patients to be identified and categorised with particular focus on; quality of life, symptom burden and access to and value of available support
1 secondary outcome
Future service developments
Time frame: Following analysis of the questionnaires completed by patients, estimated 24 months
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 30 Mar 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Breast Cancer, run by Cancer Trials Ireland at 13 sites in Ireland.
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 4 inclusion and 1 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 30 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Ireland. 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?
Needs of MBC patients in Ireland (time frame: Following analysis of the questionnaires completed by the patients, estimated 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Mar 2015.