CancerNCT02836392
CRQ Survey Study: Clinical Research Questionnaire of Oncology Patients - A Nationwide Survey
An observational study of Cancer, run by Cancer Trials Ireland at 14 sites in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,000 participants
- Where
- 14 sitesIreland
- Study dates
- May 2016to Jan 2017
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This is a translational, multicentre questionnaire study.
Who may be able to join
- 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
Who cannot join
- N/A
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Ireland14 sites
Beaumont Hospital
Beaumont Road, Dublin, 9
Bon Secours Hospital
Cork
Cork University Hospital
Cork
Saint Luke's Hospital Rathgar
Dublin, 6
Beacon Hospital
Dublin
Mater Misericordiae University Hospital
Dublin
St James Hospital
Dublin
St Vincent's University Hospital
Elm Park, Dublin 4
University Hospital Galway
Galway
Letterkenny General Hospital
Letterkenny
University Hospital Limerick
Limerick
Sligo University Hospital
Sligo
AMNCH
Tallaght, Dublin 24
University Hospital Waterford
Waterford, Co Waterford
About this study
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.
- Conditions
- Cancer
- Being tested
- Questionnaire
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Oncology patients' understanding of the term 'clinical trials' and their attitudes towards personal participation in cancer clinical research will be evaluated by questionnaire.
Measured: 1 year
Secondary outcomes (2)
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.
Measured: 1 year
The patients' experience surrounding the discussion regarding CCT participation and their actual experience when enrolled in a CCT will be investigated by questionnaire.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2016 (estimated)
- Study startMay 2016
- Primary completionDec 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cancer Trials Ireland
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02836392
- Sponsor's protocol ID
- ICORG 15-43
- Status last verified
- Aug 2017
- First submitted
- 27 Jun 2016
- Last updated
- 10 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CRQ Survey Study: Clinical Research Questionnaire of Oncology Patients - A Nationwide Survey
- ClinicalTrials.gov ID
- NCT02836392
- Acronym / sponsor ID
- ICORG 15-43
- Conditions
- Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Cancer Trials IrelandResearch network
- Study start
- May 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 19 Jul 2016 (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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a translational, multicentre questionnaire study.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| Questionnaire | Behavioural | – |
Primary outcome
Oncology patients' understanding of the term 'clinical trials' and their attitudes towards personal participation in cancer clinical research will be evaluated by questionnaire.
Time frame: 1 year
2 secondary outcomes
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.
Time frame: 1 year
The patients' experience surrounding the discussion regarding CCT participation and their actual experience when enrolled in a CCT will be investigated by questionnaire.
Time frame: 1 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 10 Aug 2017.
- Individual participant dataSharing planned: Yes
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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.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Cancer Trials Ireland at 14 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 3 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 10 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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?
Oncology patients' understanding of the term 'clinical trials' and their attitudes towards personal participation in cancer clinical research will be evaluated by questionnaire. (time frame: 1 year). 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 10 Aug 2017.