- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02541266
Imaging in Clinical Trials - a Questionnaire Study to Assess Impact of Imaging Regimes on Patient Participation (ASK)
January 27, 2020 updated by: Nandita deSouza, Institute of Cancer Research, United Kingdom
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.
Study Overview
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 Type
Observational
Enrollment (Actual)
207
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Surrey
-
Sutton, Surrey, United Kingdom, SM2 5PT
- The Royal Marsden NHS Foundation Trust
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
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
Description
Inclusion Criteria
- 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
- 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.
Exclusion Criteria -
- Inability to complete the questionnaire.
- Previously completed questionnaire.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Group 1
Patients currently recruited to studies with imaging at The Marsden
|
A short questionnaire (9 questions) will be given to the participants to complete.
|
Group 2
Patients who have previously participated in studies with imaging at The Marsden
|
A short questionnaire (9 questions) will be given to the participants to complete.
|
Group 3
Patients attending for scans as part of their clinical pathway
|
A short questionnaire (9 questions) will be given to the participants to complete.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Duration of Study - 1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Factors affecting participation in the different patient categories
Time Frame: Duration of Study - 1 year
|
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
|
Duration of Study - 1 year
|
Do opinions change after undergoing imaging procedures
Time Frame: Duration of Study - 1 year
|
Duration of Study - 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2015
Primary Completion (Actual)
August 1, 2018
Study Completion (Actual)
August 1, 2018
Study Registration Dates
First Submitted
July 22, 2015
First Submitted That Met QC Criteria
September 3, 2015
First Posted (Estimate)
September 4, 2015
Study Record Updates
Last Update Posted (Actual)
January 28, 2020
Last Update Submitted That Met QC Criteria
January 27, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 15 LO 1189
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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