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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02051010
Other study ID # ICORG 13-01
Secondary ID
Status Completed
Phase N/A
First received January 24, 2014
Last updated March 27, 2015
Start date May 2013

Study information

Verified date March 2015
Source ICORG- All Ireland Cooperative Oncology Research Group
Contact n/a
Is FDA regulated No
Health authority Ireland: Health Information and Quality Authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 500
Est. completion date
Est. primary completion date March 2015
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Signed written informed consent

- Clinical diagnosis of MBC

- Female aged 18 years or older

- Able to complete the questionnaires independently

Exclusion Criteria:

- Any patient who does not meet the above mentioned inclusion criteria.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Ireland Bon Secours Hospital Cork
Ireland Cork University Hospital Cork
Ireland South Infirmary - Victoria University Hospital Cork
Ireland Letterkenny General Hospital Donegal
Ireland Beaumont Hospital Dublin
Ireland Mater Misericordiae University Hospital and Mater Private Hospital Dublin
Ireland Saint James's Hospital Dublin
Ireland Saint Vincent Universtiy Hospital Dublin
Ireland Galway University Hospital Galway
Ireland Kerry General Hospital Kerry
Ireland Midwestern Regional Hospital Limerick
Ireland Sligo General Hospital Sligo
Ireland Waterford Regional Hospital Waterford

Sponsors (1)

Lead Sponsor Collaborator
ICORG- All Ireland Cooperative Oncology Research Group

Country where clinical trial is conducted

Ireland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Following analysis of the questionnaires completed by the patients, estimated 24 months No
Secondary Future service developments Evaluation of future service developments that will provide support to these patients Following analysis of the questionnaires completed by patients, estimated 24 months No
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