Personal Web Page In Clinical Trial Participant Education

Dana-Farber Cancer Institute

Status: Completed

Conditions: Genitourinary Cancer; Kidney Cancer; Prostate Cancer

Treatments: Other: Postwire

Study type: Interventional

Funder types: Other

Identifiers

NCT03887091

13-575

Details and patient eligibility

About

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

Full 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.

Enrollment: 99 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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99 participants in 2 patient groups

Postwire© Virtual Education Cohort

Experimental group

Description:

* 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

Treatment:

Other: Postwire

No Video Intervention

No Intervention group

Description:

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.