Clinical trial NCT03887091: Personal Web Page In Clinical Trial Participant Education
Official title: Use of a Video-based, Personalized Web Page as a Complement to Standard Patient Education for Clinical Trial Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Kidney Cancer
Genitourinary Cancer
Keywords: Web Based Tools
Video Communication
Web-based communication
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
First posted: 2019-03-22
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility 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

Primary outcomes:
measure: Number of cumulative participant caused violations over 4 cycles
timeFrame: 168 Days
Secondary outcomes:
measure: Number of times participants accessed the webpage
timeFrame: 168 Days
measure: Number of times participants accessed the webpage
timeFrame: 42 Days
measure: Number of times participants accessed the webpage
timeFrame: 84 Days
measure: Number of times participants accessed the webpage
timeFrame: 126 Days
measure: number of participant-caused protocol violations
timeFrame: 42 Days
measure: number of participant-caused protocol violations
timeFrame: 84 Days
measure: number of participant-caused protocol violations
timeFrame: 126 Days
measure: number of participant-caused protocol violations
timeFrame: 168 Days
measure: Participant reported outcomes (PRO) center on treatment satisfaction
timeFrame: 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.
measure: Participant reported outcomes (PRO) on Perceived Stress
timeFrame: 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.
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Mary-Ellen Taplin, MD
role: PRINCIPAL_INVESTIGATOR
References: