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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03887091
Other study ID # 13-575
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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.
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