Prostate CancerNCT03887091
Personal Web Page In Clinical Trial Participant Education
A study testing Postwire in people with Prostate Cancer and Kidney Cancer, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial summary
This research study is evaluating the effectiveness of video and web-based communication in clinical research compared to standard practices. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prostate Cancer, Kidney Cancer, Genitourinary Cancer
- What is being tested?
- Postwire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jul 2014to May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: 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.
Read the 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.
- Conditions
- Prostate Cancer, Kidney Cancer, Genitourinary Cancer
- Being tested
- Postwire
- Keywords
- Web Based Tools, Video Communication, Web-based communication
- Medical subject headings
- Prostatic Neoplasms, Kidney Neoplasms, Urogenital Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PostwireOther
Postwire© is a web-based, video platform
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of cumulative participant caused violations over 4 cycles
Wilcoxon Rank Sum Test (one-sided alpha = 0.10).
Measured: 168 Days
Secondary outcomes (10)
Number of times participants accessed the webpage
Pearson correlation coefficient (or Spearman, if appropriate
Measured: 168 Days
Number of times participants accessed the webpage
Pearson correlation coefficient (or Spearman, if appropriate
Measured: 42 Days
Number of times participants accessed the webpage
Pearson correlation coefficient (or Spearman, if appropriate
Measured: 84 Days
Number of times participants accessed the webpage
Pearson correlation coefficient (or Spearman, if appropriate)
Measured: 126 Days
number of participant-caused protocol violations
Pearson correlation coefficient (or Spearman, if appropriate)
Measured: 42 Days
number of participant-caused protocol violations
Pearson correlation coefficient (or Spearman, if appropriate)
Measured: 84 Days
number of participant-caused protocol violations
Pearson correlation coefficient (or Spearman, if appropriate)
Measured: 126 Days
number of participant-caused protocol violations
Pearson correlation coefficient (or Spearman, if appropriate)
Measured: 168 Days
Participant reported outcomes (PRO) center on treatment satisfaction
FACIT-TS-PS
Measured: 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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2019
- Study start21 Jul 2014
- Primary completion30 May 2017
- Study completionMay 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mary-Ellen Taplin, MD, Dana-Farber Cancer Institute
- Investigators
- Mary-Ellen Taplin, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03887091
- Sponsor's protocol ID
- 13-575
- Status last verified
- Jun 2019
- First submitted
- 14 Mar 2019
- Last updated
- 7 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a Video-based, Personalized Web Page as a Complement to Standard Patient Education for Clinical Trial Participants
- ClinicalTrials.gov ID
- NCT03887091
- Acronym / sponsor ID
- 13-575
- Conditions
- Prostate Cancer, Kidney Cancer, Genitourinary Cancer
- Keywords
- Web Based Tools, Video Communication, Web-based communication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Study start
- 21 Jul 2014 (actual)
- Primary completion
- 30 May 2017 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 22 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study is evaluating the effectiveness of video and web-based communication in clinical research compared to standard practices.
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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Postwire© Virtual Education Cohort | Experimental | Other: Postwire* 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 |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PostwirePostwire© is a web-based, video platform | Other | Postwire© Virtual Education Cohort |
Primary outcome
Number of cumulative participant caused violations over 4 cycles
Time frame: 168 Days
Wilcoxon Rank Sum Test (one-sided alpha = 0.10).
10 secondary outcomes
Number of times participants accessed the webpage
Time frame: 168 Days
Number of times participants accessed the webpage
Time frame: 42 Days
Number of times participants accessed the webpage
Time frame: 84 Days
Number of times participants accessed the webpage
Time frame: 126 Days
number of participant-caused protocol violations
Time frame: 42 Days
number of participant-caused protocol violations
Time frame: 84 Days
number of participant-caused protocol violations
Time frame: 126 Days
number of participant-caused protocol violations
Time frame: 168 Days
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2019.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary-Ellen Taplin, MD principal investigator
Dana-Farber Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Postwire in people with Prostate Cancer and Kidney Cancer, run by Dana-Farber Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of cumulative participant caused violations over 4 cycles (time frame: 168 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2019.