Using PROMIS as Part of Routine Clinical Care for Racially Diverse Prostate and Bladder Cancer Patients

NCT03156244 | Completed DMC

• 1 other identifier: LCCC1636
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer; Bladder Cancer

Keywords

PROMIS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Feasibility of enrollment

  baseline

• Preferred mode of questionnaire completion

  baseline through 90 days post treatment

• Feasibility by cohort

  baseline through 90 days post treatment

• Perceived value

  baseline through 90 days post treatment

Study Arms (2)

Caucasian

This cohort will consist of 40 white patients who are receiving either radiation or surgery for treatment of their prostate or bladder cancer.

African American

This cohort will consist of 40 African American patients who are receiving either radiation or surgery for treatment of their prostate or bladder cancer.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A racially diverse cohort of 80 prostate and bladder cancer patients will be enrolled, including both male and female patients (n=40 Black; n=40 White) from the North Carolina Cancer Hospital's Multidisciplinary Urology and Radiation Oncology clinics

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead

Study Sites (1)

Becky Green

Chapel Hill, North Carolina, 27599, United States

Location

Related Links

• UNC Lineberger Comprehensive Cancer Center Clinical Trials

MeSH Terms

Conditions

Prostatic Neoplasms; Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Urologic Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urinary Bladder Diseases; Urologic Diseases

Study Officials

• Ronald Chen, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2017
• First Posted: May 17, 2017
• Study Start: May 8, 2017
• Primary Completion: May 5, 2018
• Study Completion: May 5, 2018
• Last Updated: November 4, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)