CRQ Survey Study: Clinical Research Questionnaire of Oncology Patients - A Nationwide Survey

• Sponsor: Cancer Trials Ireland (Other)
• Overall Status: Completed
• CT.gov ID: NCT02836392
• Collaborator: (none)
• Enrollment: 1,000
• Locations: 14
• Duration (Months): 8
• Patients Per Site: 71.4
• Patients Per Site Per Month: 8.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer	Behavioral: Questionnaire

Study Design

• Study Type: Observational
• Actual Enrollment: 1000 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Study Start Date: May 1, 2016
• Actual Primary Completion Date: Dec 1, 2016
• Actual Study Completion Date: Jan 1, 2017

Outcome Measures

Primary Outcome Measures

1. Oncology patients' understanding of the term 'clinical trials' and their attitudes towards personal participation in cancer clinical research will be evaluated by questionnaire. [1 year]

Secondary Outcome Measures

1. 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. [1 year]

2. The patients' experience surrounding the discussion regarding CCT participation and their actual experience when enrolled in a CCT will be investigated by questionnaire. [1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Waterford	Waterford	Co Waterford	Ireland
2	AMNCH	Tallaght	Dublin 24	Ireland
3	St Vincent's University Hospital	Elm Park	Dublin 4	Ireland
4	Beaumont Hospital	Beaumont Road	Dublin	Ireland	9
5	Bon Secours Hospital	Cork		Ireland
6	Cork University Hospital	Cork		Ireland
7	Saint Luke's Hospital Rathgar	Dublin		Ireland	6
8	Beacon Hospital	Dublin		Ireland
9	Mater Misericordiae University Hospital	Dublin		Ireland
10	St James Hospital	Dublin		Ireland
11	University Hospital Galway	Galway		Ireland
12	Letterkenny General Hospital	Letterkenny		Ireland
13	University Hospital Limerick	Limerick		Ireland
14	Sligo University Hospital	Sligo		Ireland

Sponsors and Collaborators

• Cancer Trials Ireland

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Cancer Trials Ireland
• ClinicalTrials.gov Identifier: NCT02836392
• Other Study ID Numbers: ICORG 15-43
• First Posted: Jul 19, 2016
• Last Update Posted: Aug 10, 2017
• Last Verified: Aug 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes

Study Results

No Results Posted as of Aug 10, 2017