Personal Web Page In Clinical Trial Participant Education

Prostate Cancer Clinical Trial

Official title:

Use of a Video-based, Personalized Web Page as a Complement to Standard Patient Education for Clinical Trial Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03887091
• Other study ID #: 13-575
• Status: Completed
• Phase: N/A
• Start date: July 21, 2014
• Est. completion date: May 2019

Study information

• Verified date: June 2019
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: May 2019
• Est. primary completion date: May 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

• 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

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Genitourinary Cancer
• Kidney Cancer
• Kidney Neoplasms
• Prostate Cancer
• Urogenital Neoplasms

Intervention

Other:
• Postwire
Postwire© is a web-based, video platform

Locations

Country	Name	City	State
United States	Dana Farber Cancer Institute	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of cumulative participant caused violations over 4 cycles	Wilcoxon Rank Sum Test (one-sided alpha = 0.10).	168 Days
Secondary	Number of times participants accessed the webpage	Pearson correlation coefficient (or Spearman, if appropriate	168 Days
Secondary	Number of times participants accessed the webpage	Pearson correlation coefficient (or Spearman, if appropriate	42 Days
Secondary	Number of times participants accessed the webpage	Pearson correlation coefficient (or Spearman, if appropriate	84 Days
Secondary	Number of times participants accessed the webpage	Pearson correlation coefficient (or Spearman, if appropriate)	126 Days
Secondary	number of participant-caused protocol violations	Pearson correlation coefficient (or Spearman, if appropriate)	42 Days
Secondary	number of participant-caused protocol violations	Pearson correlation coefficient (or Spearman, if appropriate)	84 Days
Secondary	number of participant-caused protocol violations	Pearson correlation coefficient (or Spearman, if appropriate)	126 Days
Secondary	number of participant-caused protocol violations	Pearson correlation coefficient (or Spearman, if appropriate)	168 Days
Secondary	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.
Secondary	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.