Prostate Cancer Clinical Trial
Official title:
LCCC 1636: Using PROMIS as Part of Routine Clinical Care for Racially Diverse Prostate and Bladder Cancer Patients
NCT number | NCT03156244 |
Other study ID # | LCCC1636 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 8, 2017 |
Est. completion date | May 5, 2018 |
Verified date | September 2019 |
Source | UNC Lineberger Comprehensive Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
In this pilot study, a total of 80 patients with prostate or bladder cancer (40 black, 40 white) will complete 3 patient-reported outcome (PRO) surveys: baseline (pre-treatment), during treatment, and after treatment. The overall goal of this study is to assess whether collecting patient-reported data is feasible as part of clinical care of cancer patients, and whether these data are useful for clinicians and patients. Among these 80 patients, those who agree will also undergo a semi-structured interview to assess value of HRQOL assessment at the end of the study. Of specific interest is an evaluation of whether feasibility and perceived value differ between black and white participants.
Status | Completed |
Enrollment | 80 |
Est. completion date | May 5, 2018 |
Est. primary completion date | May 5, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 18 years or older - Non-Hispanic Black and White patients with a known pathologic diagnosis of prostate or bladder cancer and intent to undergo treatment. - Signed, IRB approved written informed consent. Exclusion Criteria: - Initiation of cancer-directed treatment - Race/ethnicity other than Non-Hispanic Black or Non-Hispanic White - Inability to read and speak English - Inability to comply with study for any other reason than language - Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent. |
Country | Name | City | State |
---|---|---|---|
United States | Becky Green | Chapel Hill | North Carolina |
Lead Sponsor | Collaborator |
---|---|
UNC Lineberger Comprehensive Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Feasibility of PRO assessments in a clinical setting | The feasibility of incorporating PRO assessments into the clinical setting for 80 Black and White patients undergoing treatment for bladder and prostate cancer. Feasibility is defined as at least 70% of study participants completing all three PRO assessments. | 90 days post treatment | |
Secondary | Feasibility of enrollment | The feasibility of enrolling bladder and prostate cancer patients into PRO assessment for clinical care. Feasibility of enrollment is defined as at least 37.56% of eligible patients who are approached about the study agree to enroll. | baseline | |
Secondary | Preferred mode of questionnaire completion | The proportion of study participants who chose web vs. interactive voice response (IVR) as the preferred mode for PRO data collection. It is hypothesized 50% of patients will chose the web. | baseline through 90 days post treatment | |
Secondary | Feasibility by cohort | The rates of the feasibility of PRO assessment, the feasibility of enrollment, and preferred mode of PRO assessment in Black vs. White patients. | baseline through 90 days post treatment | |
Secondary | Perceived value | Patterns and Black vs. White differences in the perceived value of PRO assessments from the patient's perspective using semi-structured interviews. | baseline through 90 days post treatment |
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