CancerASKNCT02541266
Imaging in Clinical Trials - a Questionnaire Study to Assess Impact of Imaging Regimes on Patient Participation
An observational study of Cancer, run by Institute of Cancer Research, United Kingdom at 1 site in United Kingdom.
Trial summary
This research is aimed at finding out what may influence the decision of patients to participate in trials involving imaging so that the investigators may improve our future studies so they are more patient focused and acceptable in regards to scan schedules. 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
- How many people
- 207 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Apr 2015to 1 Aug 2018
- 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: Group 1: Patients recruited to studies with imaging Group 2: Patients who have previously participated in studies with imaging Group 3: Patients attending for scans as part of their clinical pathway
Who may be able to join
- Being treated at The Royal Marsden Hospital
- Over the age of 18
- Having imaging (MRI or PET/CT) as part of research or clinical care.
- Group 1
- Currently enrolled in a research project that involves imaging (either MRI or PET/CT)
- Group 2
Show all 9Show fewer
- Previously enrolled in a research project that involved imaging (either MRI or PET/CT), where the patients involvement in the research project has now ended.
- Group 3
- Patients attending the MRI or PET/CT departments for imaging as part of their standard clinical care.
Who cannot join
- Inability to complete the questionnaire.
- Previously completed questionnaire.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Royal Marsden NHS Foundation Trust
Sutton, Surrey, SM2 5PT
About this study
This research is aimed at finding out what may influence the decision of patients to participate in trials involving imaging so that the investigators may improve our future studies so they are more patient focused and acceptable in regards to scan schedules.
Read the detailed description
This is a questionnaire study aimed at gaining a greater understanding of the patient perspective on undertaking imaging procedures, MRI and PET/CT, for research purposes. The study is to evaluate the patient opinion and perceptions of the burden of imaging associated with research. We will look at different scanning procedures of varying duration, intensity, frequency and scheduling; this will enable us to have a better understand of the factors that influence participation in research and thus help us develop protocols that are more patient focused and acceptable.
- Conditions
- Cancer
- Being tested
- Questionnaire
- Keywords
- Imaging, Questionnaire
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
A short questionnaire (9 questions) will be given to the participants to complete.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Patients currently recruited to studies with imaging at The Marsden Receives: Other: Questionnaire | |
| Group 2 | Patients who have previously participated in studies with imaging at The Marsden Receives: Other: Questionnaire | |
| Group 3 | Patients attending for scans as part of their clinical pathway Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Factors that affect patient participation in imaging research
Factors about an imaging scan - type, length, frequency or scheduling (timing in relation to treatment) - that are perceived as a significant burden when considering participation in a research study involving imaging.
Measured: Duration of Study - 1 year
Secondary outcomes (3)
Factors affecting participation in the different patient categories
Measured: Duration of Study - 1 year
Effect of current participation in a study on the perceived acceptability of imaging burden
Measured: Duration of Study - 1 year
Do opinions change after undergoing imaging procedures
Measured: Duration of Study - 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2015 (estimated)
- Study start1 Apr 2015
- Primary completion1 Aug 2018
- Study completion1 Aug 2018
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.
- More trials run by Institute of Cancer Research, United KingdomThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Cancer Research, United Kingdom
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, Royal Marsden NHS Foundation Trust
- Responsible party
- Principal investigator, Nandita deSouza, Institute of Cancer Research, United Kingdom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02541266
- Sponsor's protocol ID
- 15 LO 1189
- Acronym
- ASK
- Status last verified
- Jan 2020
- First submitted
- 22 Jul 2015
- Last updated
- 28 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging in Clinical Trials - a Questionnaire Study to Assess Impact of Imaging Regimes on Patient Participation
- ClinicalTrials.gov ID
- NCT02541266
- Acronym / sponsor ID
- ASK / 15 LO 1189
- Conditions
- Cancer
- Keywords
- Imaging, Questionnaire
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Institute of Cancer Research, United KingdomUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, Royal Marsden NHS Foundation Trust
- Study start
- 1 Apr 2015
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 4 Sep 2015 (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 research is aimed at finding out what may influence the decision of patients to participate in trials involving imaging so that the investigators may improve our future studies so they are more patient focused and acceptable in regards to scan schedules.
Detailed description
This is a questionnaire study aimed at gaining a greater understanding of the patient perspective on undertaking imaging procedures, MRI and PET/CT, for research purposes. The study is to evaluate the patient opinion and perceptions of the burden of imaging associated with research. We will look at different scanning procedures of varying duration, intensity, frequency and scheduling; this will enable us to have a better understand of the factors that influence participation in research and thus help us develop protocols that are more patient focused and acceptable.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: QuestionnairePatients currently recruited to studies with imaging at The Marsden |
| Group 2 | – | Other: QuestionnairePatients who have previously participated in studies with imaging at The Marsden |
| Group 3 | – | Other: QuestionnairePatients attending for scans as part of their clinical pathway |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Group 1: Patients recruited to studies with imaging Group 2: Patients who have previously participated in studies with imaging Group 3: Patients attending for scans as part of their clinical pathway
Key inclusion criteria (9 listed)
- Being treated at The Royal Marsden Hospital
- Over the age of 18
- Having imaging (MRI or PET/CT) as part of research or clinical care.
- Group 1
- Group 2
Key exclusion criteria (2 listed)
- Inability to complete the questionnaire.
- Previously completed questionnaire.
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 |
|---|---|---|
| QuestionnaireA short questionnaire (9 questions) will be given to the participants to complete. | Other | Group 1, Group 2, Group 3 |
Primary outcome
Factors that affect patient participation in imaging research
Time frame: Duration of Study - 1 year
Factors about an imaging scan - type, length, frequency or scheduling (timing in relation to treatment) - that are perceived as a significant burden when considering participation in a research study involving imaging.
3 secondary outcomes
Factors affecting participation in the different patient categories
Time frame: Duration of Study - 1 year
Effect of current participation in a study on the perceived acceptability of imaging burden
Time frame: Duration of Study - 1 year
Do opinions change after undergoing imaging procedures
Time frame: Duration of Study - 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 28 Jan 2020.
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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.
1 site 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 Institute of Cancer Research, United Kingdom at 1 site in United Kingdom.
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 9 inclusion and 2 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 28 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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?
Factors that affect patient participation in imaging research (time frame: Duration of Study - 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 28 Jan 2020.