Personal Web Page In Clinical Trial Participant Education

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

Detailed Description
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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.

Official Title
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Use of a Video-based, Personalized Web Page as a Complement to Standard Patient Education for Clinical Trial Participants

Conditions
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Prostate Cancer, Kidney Cancer, Genitourinary Cancer

Intervention / Treatment
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* Other: Postwire


Participation Criteria
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Eligibility Criteria
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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

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: Postwire© Virtual Education Cohort<br>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 | Other: Postwire<br>* Postwire© is a web-based, video platform<br>|
| No Intervention: No Video Intervention<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of cumulative participant caused violations over 4 cycles | Wilcoxon Rank Sum Test (one-sided alpha = 0.10). | 168 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of times participants accessed the webpage | Pearson correlation coefficient (or Spearman, if appropriate | 168 Days | 
| Number of times participants accessed the webpage | Pearson correlation coefficient (or Spearman, if appropriate | 42 Days | 
| Number of times participants accessed the webpage | Pearson correlation coefficient (or Spearman, if appropriate | 84 Days | 
| Number of times participants accessed the webpage | Pearson correlation coefficient (or Spearman, if appropriate) | 126 Days | 
| number of participant-caused protocol violations | Pearson correlation coefficient (or Spearman, if appropriate) | 42 Days | 
| number of participant-caused protocol violations | Pearson correlation coefficient (or Spearman, if appropriate) | 84 Days | 
| number of participant-caused protocol violations | Pearson correlation coefficient (or Spearman, if appropriate) | 126 Days | 
| number of participant-caused protocol violations | Pearson correlation coefficient (or Spearman, if appropriate) | 168 Days | 
| Participant reported outcomes (PRO) center on treatment satisfaction | FACIT-TS-PS | 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. | 
| Participant reported outcomes (PRO) on Perceived Stress | PSS-10 | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Web Based Tools, Video Communication, Web-based communication