Developing an Online Clinical Trial Specific Question Prompt List

Cancer Clinical Trial

Official title:

Developing an Online Clinical Trial Specific Question Prompt List

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02030379
• Other study ID #: MCC-14970
• Secondary ID: HM14970
• Status: Terminated
• Phase: N/A
• First received: December 10, 2013
• Last updated: July 6, 2015
• Start date: July 2013
• Est. completion date: November 2014

Study information

• Verified date: July 2015
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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 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

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Cancer

Intervention

Behavioral:
• QPL-CT
Use the QPL-CT to prioritize questions

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Test the feasibility of using the online QPL-CT for patients and physicians	Patients will complete an exit interview at the completion of patient's consultation asking about the patient's impressions of the online QPL-CT including its ease of use and the patient's perceptions of its influence on consultation communication. Physicians will complete a brief interview on one occasion at the completion of patient recruitment asking about the impact of the prioritized QPL-CT on consultation communication.	30 days	No
Primary	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	No
Secondary	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	No