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ClinicalTrials.gov Identifier: NCT03887091
Recruitment Status : Completed
First Posted : March 22, 2019
Last Update Posted : June 7, 2019
Sponsor:
Information provided by (Responsible Party):
Mary-Ellen Taplin, MD, Dana-Farber Cancer Institute

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

Condition or disease Intervention/treatment Phase
Prostate Cancer Kidney Cancer Genitourinary Cancer Other: Postwire Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Use of a Video-based, Personalized Web Page as a Complement to Standard Patient Education for Clinical Trial Participants
Actual Study Start Date : July 21, 2014
Actual Primary Completion Date : May 30, 2017
Actual Study Completion Date : May 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Postwire© Virtual Education Cohort
  • 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.
  • In randomized into the Virtual Education Cohort:A video based, personalized web page will be created that has information related to the participants therapeutic clinical trial.
  • This web page will have videos of a research nurse explaining how to take study medication(s), how to fill out the study drug diary, and a description of the main side effects associated with the study drugs.
  • Clinic Visit Video Recording Cycle 1-4/Day 1
  • Participants from both groups will be asked to complete two surveys before each Day 1 clinic visit for Cycles 1-7
Other: Postwire
Postwire© is a web-based, video platform

No Intervention: No Video 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

  • Participants randomized to the control cohort will follow standard of care procedures involving clinic visits that do not include the use of video or access to a personalized web page.
  • Participants from both groups will be asked to complete two surveys before each Day 1 clinic visit for Cycles 1-7.



Primary Outcome Measures :
  1. Number of cumulative participant caused violations over 4 cycles [ Time Frame: 168 Days ]
    Wilcoxon Rank Sum Test (one-sided alpha = 0.10).


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03887091


Locations
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United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
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Principal Investigator: Mary-Ellen Taplin, MD Dana-Farber Cancer Institute

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Responsible Party: Mary-Ellen Taplin, MD, Prinicipal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT03887091     History of Changes
Other Study ID Numbers: 13-575
First Posted: March 22, 2019    Key Record Dates
Last Update Posted: June 7, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Data can be shared no earlier than 1 year following the date of publication
Access Criteria: Requests may be directed to Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mary-Ellen Taplin, MD, Dana-Farber Cancer Institute:
Web Based Tools
Video Communication
Web-based communication
Additional relevant MeSH terms:
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Kidney Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urologic Neoplasms
Kidney Diseases
Urologic Diseases