Personal Web Page In Clinical Trial Participant Education

• Sponsor: Dana-Farber Cancer Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT03887091
• Collaborator: (none)
• Enrollment: 99
• Location: 1
• Arms: 2
• Actual Duration (Months): 57.3
• Patients Per Site Per Month: 1.7

Study Details

Study Description

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	N/A

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 Design

• Study Type: Interventional
• 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: Jul 21, 2014
• Actual Primary Completion Date: May 30, 2017
• Actual Study Completion Date: May 1, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Number of cumulative participant caused violations over 4 cycles [168 Days]

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

Secondary Outcome Measures

1. Number of times participants accessed the webpage [168 Days]

   Pearson correlation coefficient (or Spearman, if appropriate

2. Number of times participants accessed the webpage [42 Days]

   Pearson correlation coefficient (or Spearman, if appropriate

3. Number of times participants accessed the webpage [84 Days]

   Pearson correlation coefficient (or Spearman, if appropriate

4. Number of times participants accessed the webpage [126 Days]

   Pearson correlation coefficient (or Spearman, if appropriate)

5. number of participant-caused protocol violations [42 Days]

   Pearson correlation coefficient (or Spearman, if appropriate)

6. number of participant-caused protocol violations [84 Days]

   Pearson correlation coefficient (or Spearman, if appropriate)

7. number of participant-caused protocol violations [126 Days]

   Pearson correlation coefficient (or Spearman, if appropriate)

8. number of participant-caused protocol violations [168 Days]

   Pearson correlation coefficient (or Spearman, if appropriate)

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dana Farber Cancer Institute	Boston	Massachusetts	United States	02115

Sponsors and Collaborators

• Dana-Farber Cancer Institute

Investigators

• Principal Investigator: Mary-Ellen Taplin, MD, Dana-Farber Cancer Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mary-Ellen Taplin, MD, Prinicipal Investigator, Dana-Farber Cancer Institute
• ClinicalTrials.gov Identifier: NCT03887091
• Other Study ID Numbers: 13-575
• First Posted: Mar 22, 2019
• Last Update Posted: Jun 7, 2019
• Last Verified: Jun 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• 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, Prinicipal Investigator, Dana-Farber Cancer Institute: Web Based Tools; Video Communication; Web-based communication
• Additional relevant MeSH terms: Kidney Neoplasms; Urogenital Neoplasms

Study Results

No Results Posted as of Jun 7, 2019