Personal Web Page In Clinical Trial Participant Education

NCT ID: NCT03887091

Last Updated: 2019-06-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 99 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-21
• Study Completion Date: 2019-05-31

Brief Summary

This research study is evaluating the effectiveness of video and web-based communication in clinical research compared to standard practices.

Detailed Description

Research has shown that many clinical trial participants are confused about clinical trials. Common participant misunderstandings include the idea of randomization, benefits to participants' health, the proven nature of the study intervention, and failure to recognize the primary purpose of the trial. There can sometimes be unintended miscommunication between the study doctor and/or nursing staff and participants. Thus, there is a clear need to identify ways to improve communication during clinical trials. The investigator's current culture of web-based information presentation, whether it takes the form of PowerPoint presentations, videos, websites, or audio tools, suggests that adding such technology to the cancer research realm may improve a participant's clinical trial experience and possibly improve participant understanding and safety while enrolled on a clinical trial. Video and web-based tools in cancer research have the potential to transform clinical trial practice.

Conditions

Prostate Cancer; Kidney Cancer; Genitourinary Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Postwire© Virtual Education Cohort

• Participants will be administered a brief questionnaire that asks questions about participant internet access, use, and understanding (Appendix B). This questionnaire will be used to determine eligibility.
• In randomized into the Virtual Education Cohort:A video based, personalized web page will be created that has information related to the participants therapeutic clinical trial.
• This web page will have videos of a research nurse explaining how to take study medication(s), how to fill out the study drug diary, and a description of the main side effects associated with the study drugs.
• Clinic Visit Video Recording Cycle 1-4/Day 1
• Participants from both groups will be asked to complete two surveys before each Day 1 clinic visit for Cycles 1-7

Group Type: EXPERIMENTAL

Postwire

Intervention Type: OTHER

Postwire© is a web-based, video platform

No Video Intervention

Participants will be administered a brief questionnaire that asks questions about participant internet access, use, and understanding (Appendix B). This questionnaire will be used to determine eligibility

• Participants randomized to the control cohort will follow standard of care procedures involving clinic visits that do not include the use of video or access to a personalized web page.
• Participants from both groups will be asked to complete two surveys before each Day 1 clinic visit for Cycles 1-7.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Postwire

Postwire© is a web-based, video platform

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Participants must be ≥ 18 years of age
• Participants must have an advanced or metastatic genitourinary malignancy (prostate or kidney cancer)
• Participants must be consented to one of the selected clinical trials (see Appendix A)
• Participants must be able to read and write English
• Participants must have access to the internet at a minimum of once per week
• Participants must use the internet at a minimum of once per week
• Participants must feel at least somewhat confident in how to use the internet, as determined by the eligibility questionnaire to be completed by the participant

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Mary-Ellen Taplin, MD

Prinicipal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mary-Ellen Taplin, MD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

13-575

Identifier Type: -

Identifier Source: org_study_id