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OpenTrials
Completed

NCT Number: NCT03887091

Personal Web Page In Clinical Trial Participant Education

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

Postwire

Other

Postwire© is a web-based, video platform

Primary outcomes

  1. Number of cumulative participant caused violations over 4 cycles

    Time frame: 168 Days

    Wilcoxon Rank Sum Test (one-sided alpha = 0.10).

Secondary outcomes

  1. Number of times participants accessed the webpage

    Time frame: 168 Days

    Pearson correlation coefficient (or Spearman, if appropriate

  2. Number of times participants accessed the webpage

    Time frame: 42 Days

    Pearson correlation coefficient (or Spearman, if appropriate

  3. Number of times participants accessed the webpage

    Time frame: 84 Days

    Pearson correlation coefficient (or Spearman, if appropriate

  4. Number of times participants accessed the webpage

    Time frame: 126 Days

    Pearson correlation coefficient (or Spearman, if appropriate)

  5. number of participant-caused protocol violations

    Time frame: 42 Days

    Pearson correlation coefficient (or Spearman, if appropriate)

  6. number of participant-caused protocol violations

    Time frame: 84 Days

    Pearson correlation coefficient (or Spearman, if appropriate)

  7. number of participant-caused protocol violations

    Time frame: 126 Days

    Pearson correlation coefficient (or Spearman, if appropriate)

  8. number of participant-caused protocol violations

    Time frame: 168 Days

    Pearson correlation coefficient (or Spearman, if appropriate)

  9. Participant reported outcomes (PRO) center on treatment satisfaction

    Time frame: 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

  10. Participant reported outcomes (PRO) on Perceived Stress

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2019
First posted
Mar 22, 2019
Registry last updated
Jun 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.