Developing an Online Clinical Trial Specific Question Prompt List

Study Overview
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Brief Summary
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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
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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

Official Title
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Developing an Online Clinical Trial Specific Question Prompt List

Conditions
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Cancer

Intervention / Treatment
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* Behavioral: QPL-CT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cancer diagnosis Fluent in English eligible for a therapeutic clinical trial Patients of recruited oncologists Exclusion Criteria: Healthy subjects Not eligible for a therapeutic clinical trial

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Online QPL-CT to Oncologist<br>Use the online QPL-CT to prioritize their questions and the prioritized list will be conveyed to their oncologist | Behavioral: QPL-CT<br>* Use the QPL-CT to prioritize questions<br>|
| Experimental: Online QPL-CT<br>Use the online QPL-CT to prioritize their questions. | Behavioral: QPL-CT<br>* Use the QPL-CT to prioritize questions<br>|
| Experimental: Pencil and Paper QPL-CT<br>Use pencil and paper QPL-CT to prioritize their questions | Behavioral: QPL-CT<br>* Use the QPL-CT to prioritize questions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer