CancerNCT02030379
Developing an Online Clinical Trial Specific Question Prompt List
A study testing QPL-CT in people with Cancer, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
The investigators will leverage e-technologies to provide an online version of the Question Prompt LIst (QPL-CT), that patients access via available iPads, enabling both the real-time prioritizing of patient questions as well as the seamless delivery of these questions to their treating physician (and other members of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- QPL-CT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Nov 2014
- Phase
- Interventional
- 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
Who may be able to join
- Cancer diagnosis
- Fluent in English
- eligible for a therapeutic clinical trial
- Patients of recruited oncologists
Who cannot join
- Healthy subjects
- Not eligible for a therapeutic clinical trial
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
The investigators will leverage e-technologies to provide an online version of the Question Prompt LIst (QPL-CT), that patients access via available iPads, enabling both the real-time prioritizing of patient questions as well as the seamless delivery of these questions to their treating physician (and other members of their clinical team) via the VCU Health System (VCUHS) patient portal, and the electronic medical record (EMR) prior to a consultation to discuss a clinical trial
Read the detailed description
The investigators propose to conduct pilot work to inform our knowledge of optimal methods of utilizing QPLs and will use the QPL-CT as an example. The investigators will leverage e-technologies to provide an online version of the QPL-CT, that patients access via available iPads, enabling both the real-time prioritizing of patient questions as well as the seamless delivery of these questions to their treating physician (and other members of their clinical team) via the VCU Health System (VCUHS) patient portal, and the EMR prior to a consultation to discuss a clinical trial. The investigators will use a pilot randomized clinical trial design to demonstrate the efficacy of the online QPL-CT versus a paper and pencil QPL-CT to increase question asking, patient understanding of trial information and reduce patients conflict over their upcoming decision to join a trial
- Conditions
- Cancer
- Being tested
- QPL-CT
- Keywords
- Cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QPL-CTBehavioural
Use the QPL-CT to prioritize questions
| Study group | Role | What they receive |
|---|---|---|
| Online QPL-CT to Oncologist | Experimental | Use the online QPL-CT to prioritize their questions and the prioritized list will be conveyed to their oncologist Receives: Behavioral: QPL-CT |
| Online QPL-CT | Experimental | Use the online QPL-CT to prioritize their questions. Receives: Behavioral: QPL-CT |
| Pencil and Paper QPL-CT | Experimental | Use pencil and paper QPL-CT to prioritize their questions Receives: Behavioral: QPL-CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Online QPL-CT to Oncologist
Use online QPL-CT to prioritize their questions and the prioritized list will be conveyed to their oncologist. Investigators will evaluate the efficacy of the online QPL-CT to increase question asking, patient understanding of trial information and reduce patients conflict over their upcoming decision to join a trial.
Measured: 30 days
Secondary outcomes (1)
Impact of providing physicians patient's QPL-CT
Examine the impact of providing physicians their patient's prioritized QPL-CT on information provision and decision making process as measured by the Decision Analysis System for Oncology
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2014 (estimated)
- Study startJul 2013
- Primary completionNov 2014
- Study completionNov 2014
Why it stopped: Funding unavailable
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard Brown, PhD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02030379
- Sponsor's protocol ID
- MCC-14970
- Other IDs
- HM14970
- Status last verified
- Jul 2015
- First submitted
- 10 Dec 2013
- Last updated
- 7 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing an Online Clinical Trial Specific Question Prompt List
- ClinicalTrials.gov ID
- NCT02030379
- Acronym / sponsor ID
- MCC-14970
- Conditions
- Cancer
- Keywords
- Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding unavailable
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 8 Jan 2014 (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.
The investigators will leverage e-technologies to provide an online version of the Question Prompt LIst (QPL-CT), that patients access via available iPads, enabling both the real-time prioritizing of patient questions as well as the seamless delivery of these questions to their treating physician (and other members of their clinical team) via the VCU Health System (VCUHS) patient portal, and the electronic medical record (EMR) prior to a consultation to discuss a clinical trial
Detailed description
The investigators propose to conduct pilot work to inform our knowledge of optimal methods of utilizing QPLs and will use the QPL-CT as an example. The investigators will leverage e-technologies to provide an online version of the QPL-CT, that patients access via available iPads, enabling both the real-time prioritizing of patient questions as well as the seamless delivery of these questions to their treating physician (and other members of their clinical team) via the VCU Health System (VCUHS) patient portal, and the EMR prior to a consultation to discuss a clinical trial. The investigators will use a pilot randomized clinical trial design to demonstrate the efficacy of the online QPL-CT versus a paper and pencil QPL-CT to increase question asking, patient understanding of trial information and reduce patients conflict over their upcoming decision to join a trial
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Online QPL-CT to Oncologist | Experimental | Behavioral: QPL-CTUse the online QPL-CT to prioritize their questions and the prioritized list will be conveyed to their oncologist |
| Online QPL-CT | Experimental | Behavioral: QPL-CTUse the online QPL-CT to prioritize their questions. |
| Pencil and Paper QPL-CT | Experimental | Behavioral: QPL-CTUse pencil and paper QPL-CT to prioritize their questions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Cancer diagnosis
- Fluent in English
- eligible for a therapeutic clinical trial
- Patients of recruited oncologists
Key exclusion criteria (2 listed)
- Healthy subjects
- Not eligible for a therapeutic clinical trial
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 |
|---|---|---|
| QPL-CTUse the QPL-CT to prioritize questions | Behavioural | Online QPL-CT, Online QPL-CT to Oncologist, Pencil and Paper QPL-CT |
Primary outcome
Online QPL-CT to Oncologist
Time frame: 30 days
Use online QPL-CT to prioritize their questions and the prioritized list will be conveyed to their oncologist. Investigators will evaluate the efficacy of the online QPL-CT to increase question asking, patient understanding of trial information and reduce patients conflict over their upcoming decision to join a trial.
1 secondary outcome
Impact of providing physicians patient's QPL-CT
Time frame: 30 days
Results and safety
The study was stopped early (reason given: Funding unavailable). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2015.
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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.
Richard Brown, PhD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing QPL-CT in people with Cancer, run by Virginia Commonwealth University at 1 site in United States.
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 4 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: stopped early, as of the sponsor's last update on 7 Jul 2015. 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 States. 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 was stopped early (reason given: Funding unavailable). Results are not available in the source record.
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?
Online QPL-CT to Oncologist (time frame: 30 days). 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 7 Jul 2015.