Use of a Video-based, Personalized Web Page as a Complement to Standard Patient Education for Clinical Trial Participants
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Prostate Cancer
- Sponsor
- Dana-Farber Cancer Institute
- Enrollment
- 99
- Locations
- 1
- Primary Endpoint
- Number of cumulative participant caused violations over 4 cycles
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Mary-Ellen Taplin, MD
Prinicipal Investigator
Dana-Farber Cancer Institute
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Number of cumulative participant caused violations over 4 cycles
Time Frame: 168 Days
Wilcoxon Rank Sum Test (one-sided alpha = 0.10).
Secondary Outcomes
- Participant reported outcomes (PRO) center on treatment satisfaction(PROs collected on Cycle 1 Day 1 and each day 1 of a cycle thereafter until Cycle 7 Day 1, approximately over the course of 7 months.)
- Number of times participants accessed the webpage(126 Days)
- number of participant-caused protocol violations(168 Days)
- Participant reported outcomes (PRO) on Perceived Stress(PROs collected on Cycle 1 Day 1 and each day 1 of a cycle thereafter until Cycle 7 Day 1, approximately over the course of 7 months.)