Clinical trial NCT02836392: CRQ Survey Study: Clinical Research Questionnaire of Oncology Patients - A Nationwide Survey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Lead sponsor: Cancer Trials Ireland
Sponsor class: NETWORK
First posted: 2016-07-19
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This is a translational, multicentre questionnaire study.

Brief summary: This is a translational, multicentre questionnaire study. The study design follows that of a cross sectional, quantitative research approach. Data collection will involve self-administered, paper-based questionnaires. The method of data collection allows for a large sample size without major expense. The questionnaires are comprised of several questions examining areas such as demographic details, cancer diagnosis, understanding of the term 'clinical trials', attitudes to personal participation in cancer clinical research and the experience of patients who previously participated in a cancer clinical trial. The study will be opened in all interested hospitals in Ireland following initiation of the study at each site. Questionnaire completion will be seen as implied informed consent and no formal consent will need to be signed by the patient. The paper-based questionnaire responses will be electronically and anonymously recorded in a computer database to facilitate analysis.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of malignancy
* Aged 18 years or older
* Ability to complete the questionnaire or independently or with the help of a friend, relative, or staff member of the oncology department

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Oncology patients' understanding of the term 'clinical trials' and their attitudes towards personal participation in cancer clinical research will be evaluated by questionnaire.
timeFrame: 1 year
Secondary outcomes:
measure: The patient related factors, including level of education and socioeconomic status that influence their decision regarding participation in a cancer clinical trial (CCT) will be explored by questionnaire.
timeFrame: 1 year
measure: The patients' experience surrounding the discussion regarding CCT participation and their actual experience when enrolled in a CCT will be investigated by questionnaire.
timeFrame: 1 year
Other outcomes:
Locations:
city: Waterford
country: Ireland
facility: University Hospital Waterford
state: Co Waterford
city: Tallaght
country: Ireland
facility: AMNCH
state: Dublin 24
city: Elm Park
country: Ireland
facility: St Vincent's University Hospital
state: Dublin 4
city: Beaumont Road
country: Ireland
facility: Beaumont Hospital
state: Dublin
city: Cork
country: Ireland
facility: Bon Secours Hospital
city: Cork
country: Ireland
facility: Cork University Hospital
city: Dublin
country: Ireland
facility: Saint Luke's Hospital Rathgar
city: Dublin
country: Ireland
facility: Beacon Hospital
city: Dublin
country: Ireland
facility: Mater Misericordiae University Hospital
city: Dublin
country: Ireland
facility: St James Hospital
city: Galway
country: Ireland
facility: University Hospital Galway
city: Letterkenny
country: Ireland
facility: Letterkenny General Hospital
city: Limerick
country: Ireland
facility: University Hospital Limerick
city: Sligo
country: Ireland
facility: Sligo University Hospital
Study officials:
References: