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This research study is evaluating the effectiveness of video and web-based communication in clinical research compared to standard practices.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Postwire© Virtual Education Cohort | Experimental |
|
|
| No Video Intervention | No Intervention | 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
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Postwire | Other | Postwire© is a web-based, video platform |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of cumulative participant caused violations over 4 cycles | Wilcoxon Rank Sum Test (one-sided alpha = 0.10). | 168 Days |
| 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 |
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| Name | Affiliation | Role |
|---|---|---|
| Mary-Ellen Taplin, MD | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research
Data can be shared no earlier than 1 year following the date of publication
Requests may be directed to Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D007680 | Kidney Neoplasms |
| D014565 | Urogenital Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
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| 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. |
| D000091662 |
| Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D014571 | Urologic Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |