Personal Web Page In Clinical Trial Participant Education

Not Applicable

Completed

• Conditions: Prostate Cancer; Kidney Cancer; Genitourinary Cancer
• Interventions: Other: Postwire

• Registration Number: NCT03887091
• Lead Sponsor: Dana-Farber Cancer Institute

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.

Study Timeline

• Study Start: 2014-07-21
• Primary Completion: 2017-05-30
• Study First Submitted: 2019-03-14
• Study First Submitted QC: 2019-03-20
• Study First Posted: 2019-03-22
• Study Completion: 2019-05
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-06
• Last Update Posted: 2019-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Postwire© Virtual Education Cohort	Postwire	* 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

Primary Outcome Measures

Name	Time	Method
Number of cumulative participant caused violations over 4 cycles	168 Days	Wilcoxon Rank Sum Test (one-sided alpha = 0.10).

Secondary Outcome Measures

Name	Time	Method
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.	FACIT-TS-PS
Number of times participants accessed the webpage	126 Days	Pearson correlation coefficient (or Spearman, if appropriate)
number of participant-caused protocol violations	168 Days	Pearson correlation coefficient (or Spearman, if appropriate)
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.	PSS-10

Trial Locations

Locations (1)

Dana Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States