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Imaging in Clinical Trials - a Questionnaire Study to Assess Impact of Imaging Regimes on Patient Participation (ASK)

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ClinicalTrials.gov Identifier: NCT02541266
Recruitment Status : Unknown
Verified September 2017 by NdeSouza, Institute of Cancer Research, United Kingdom.
Recruitment status was:  Recruiting
First Posted : September 4, 2015
Last Update Posted : September 15, 2017
Sponsor:
Collaborators:
National Institute for Health Research, United Kingdom
Royal Marsden NHS Foundation Trust
Information provided by (Responsible Party):
NdeSouza, Institute of Cancer Research, United Kingdom

Brief 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.

Condition or disease Intervention/treatment
Cancer Other: Questionnaire

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.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Imaging in Clinical Trials - a Questionnaire Study to Assess Impact of Imaging Regimes on Patient Participation
Study Start Date : November 2015
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Group 1
Patients currently recruited to studies with imaging at The Marsden
Other: Questionnaire
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
Other: Questionnaire
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
Other: Questionnaire
A short questionnaire (9 questions) will be given to the participants to complete.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Factors affecting participation in the different patient categories [ Time Frame: Duration of Study - 1 year ]
  2. Effect of current participation in a study on the perceived acceptability of imaging burden [ Time Frame: Duration of Study - 1 year ]
  3. Do opinions change after undergoing imaging procedures [ Time Frame: Duration of Study - 1 year ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02541266


Contacts
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Contact: Tiffany Rushen 02086613339 tiffany.rushen@rmh.nhs.uk
Contact: Katherine May 02086613339 Katherine.May@rmh.nhs.uk

Locations
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United Kingdom
The Royal Marsden NHS Foundation Trust Recruiting
Sutton, Surrey, United Kingdom, SM2 5PT
Contact: Nandita deSouza, Professor    0208 661 3289    nandita.desouza@icr.ac.uk   
Contact: Katherine May, BSc    0208 661 3340    katherine.may@rmh.nhs.uk   
Sponsors and Collaborators
Institute of Cancer Research, United Kingdom
National Institute for Health Research, United Kingdom
Royal Marsden NHS Foundation Trust

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Responsible Party: NdeSouza, Professor of Translational Imaging, Institute of Cancer Research, United Kingdom
ClinicalTrials.gov Identifier: NCT02541266     History of Changes
Other Study ID Numbers: 15 LO 1189
First Posted: September 4, 2015    Key Record Dates
Last Update Posted: September 15, 2017
Last Verified: September 2017
Keywords provided by NdeSouza, Institute of Cancer Research, United Kingdom:
Imaging
Questionnaire