NCT03887091

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P50-P75 for not_applicable prostate-cancer

Timeline
Completed

Started Jul 2014

Typical duration for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 21, 2014

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2017

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

March 14, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 22, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

June 7, 2019

Status Verified

June 1, 2019

Enrollment Period

2.9 years

First QC Date

March 14, 2019

Last Update Submit

June 6, 2019

Conditions

Prostate CancerKidney CancerGenitourinary Cancer

Keywords

Web Based ToolsVideo CommunicationWeb-based communication

Outcome Measures

Primary Outcomes (1)

  • Number of cumulative participant caused violations over 4 cycles

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

    168 Days

Secondary Outcomes (10)

  • Number of times participants accessed the webpage

    168 Days

  • Number of times participants accessed the webpage

    42 Days

  • Number of times participants accessed the webpage

    84 Days

  • Number of times participants accessed the webpage

    126 Days

  • number of participant-caused protocol violations

    42 Days

  • +5 more secondary outcomes

Study Arms (2)

Postwire© Virtual Education Cohort

EXPERIMENTAL

* 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

No Video Intervention

NO 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.

Interventions

PostwireOTHER

Postwire© is a web-based, video platform

Postwire© Virtual Education Cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
* 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Prostatic NeoplasmsKidney NeoplasmsUrogenital Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesUrologic NeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsKidney DiseasesUrologic Diseases

Study Officials

  • Mary-Ellen Taplin, MD

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prinicipal Investigator

Study Record Dates

First Submitted

March 14, 2019

First Posted

March 22, 2019

Study Start

July 21, 2014

Primary Completion

May 30, 2017

Study Completion

May 1, 2019

Last Updated

June 7, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, 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

Locations

US(1)