Genitourinary Cancer, Kidney Cancer, Prostate Cancer
Conditions
Keywords
Web Based Tools, Video Communication, Web-based communication
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.
Interventions
OTHERPostwire
Postwire© is a web-based, video platform
Sponsors
Dana-Farber Cancer Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of cumulative participant caused violations over 4 cycles | 168 Days | Wilcoxon Rank Sum Test (one-sided alpha = 0.10). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of times participants accessed the webpage | 168 Days | Pearson correlation coefficient (or Spearman, if appropriate |
| number of participant-caused protocol violations | 42 Days | Pearson correlation coefficient (or Spearman, if appropriate) |
| 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 |
| 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 |
Countries
United States
Outcome results
None listed