Personal Web Page In Clinical Trial Participant Education

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

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

Study Overview

• Status: Completed
• Conditions: Kidney Cancer; Prostate Cancer; Genitourinary Cancer
• Intervention / Treatment: Other: Postwire

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.

• Study Type: Interventional
• Enrollment (Actual): 99
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Dana Farber Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of cumulative participant caused violations over 4 cycles	Wilcoxon Rank Sum Test (one-sided alpha = 0.10).	168 Days

Secondary Outcome Measures

Outcome Measure	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	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.

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2014
• Primary Completion (Actual): May 30, 2017
• Study Completion (Actual): May 1, 2019

Study Registration Dates

• First Submitted: March 14, 2019
• First Submitted That Met QC Criteria: March 20, 2019
• First Posted (Actual): March 22, 2019

Study Record Updates

• Last Update Posted (Actual): June 7, 2019
• Last Update Submitted That Met QC Criteria: June 6, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Web Based Tools; Video Communication; Web-based communication
• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Kidney Neoplasms; Urogenital Neoplasms
• Other Study ID Numbers: 13-575

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD 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
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: Requests may be directed to Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No