Prostate Cancer Clinical Trial
Official title:
Use of a Video-based, Personalized Web Page as a Complement to Standard Patient Education for Clinical Trial Participants
NCT number | NCT03887091 |
Other study ID # | 13-575 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 21, 2014 |
Est. completion date | May 2019 |
Verified date | June 2019 |
Source | Dana-Farber Cancer Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This research study is evaluating the effectiveness of video and web-based communication in clinical research compared to standard practices.
Status | Completed |
Enrollment | 99 |
Est. completion date | May 2019 |
Est. primary completion date | May 30, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
- 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 |
Country | Name | City | State |
---|---|---|---|
United States | Dana Farber Cancer Institute | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Dana-Farber Cancer Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of cumulative participant caused violations over 4 cycles | Wilcoxon Rank Sum Test (one-sided alpha = 0.10). | 168 Days | |
Secondary | Number of times participants accessed the webpage | Pearson correlation coefficient (or Spearman, if appropriate | 168 Days | |
Secondary | Number of times participants accessed the webpage | Pearson correlation coefficient (or Spearman, if appropriate | 42 Days | |
Secondary | Number of times participants accessed the webpage | Pearson correlation coefficient (or Spearman, if appropriate | 84 Days | |
Secondary | Number of times participants accessed the webpage | Pearson correlation coefficient (or Spearman, if appropriate) | 126 Days | |
Secondary | number of participant-caused protocol violations | Pearson correlation coefficient (or Spearman, if appropriate) | 42 Days | |
Secondary | number of participant-caused protocol violations | Pearson correlation coefficient (or Spearman, if appropriate) | 84 Days | |
Secondary | number of participant-caused protocol violations | Pearson correlation coefficient (or Spearman, if appropriate) | 126 Days | |
Secondary | number of participant-caused protocol violations | Pearson correlation coefficient (or Spearman, if appropriate) | 168 Days | |
Secondary | 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. | |
Secondary | 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. |
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