SUPPORT HOTLINE (888) 901-2226
Donate Now

BRIEF TITLE: LCCC 1636: Using PROMIS as Part of Routine Clinical Care for Racially Diverse Prostate and Bladder Cancer Patients

LCCC 1636: Using PROMIS as Part of Routine Clinical Care for Racially Diverse Prostate and Bladder Cancer Patients

  • Org Study ID: LCCC1636
  • Secondary ID:
  • NCT ID: NCT03156244
  • NCT Alias:
  • Sponsor: UNC Lineberger Comprehensive Cancer Center - Other
  • Source: UNC Lineberger Comprehensive Cancer Center

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.

Detailed Description

Cancer treatments, including surgery, radiotherapy and chemotherapy, are often linked to
acute and late side effects. Historically, these effects were assessed by physicians and
scored using standardized scales such as the Common Terminology Criteria for Adverse Events
(CTCAE). Thorough and accurate assessment of symptoms facilitates timely and patient-centered
symptom management.

Multiple studies have demonstrated that PROs more accurately capture patient symptoms than
physician assessment. In a prospective trial, Falchook et al. investigated patient vs.
physician report of symptoms in head and neck cancer patients undergoing radiotherapy (N=44).
Patients and physicians separately completed weekly symptom assessments during treatment and
once during follow-up. Patients tended to report more severe symptoms than physicians. For
example, in week six, physicians rated 86% of patients' fatigue as non-existent or mild while
86% of patients rated their own fatigue as moderate to very severe. In a larger study
conducted at Memorial Sloan-Kettering Cancer Center of 163 lung cancer patients undergoing
chemotherapy, Basch et al. similarly examined patient vs. physician report of symptoms over
one year. Compared to patients, physicians reported less severe and lower rates of fatigue,
nausea, and pain and higher functional status.

Findings from these prior studies are consistent with evidence from a recent systematic
review, which concluded that PRO data were essential for the evaluation of symptoms in cancer
survivors. Many researchers have hypothesized the reasons behind this discrepancy in
physician/patient ratings of symptoms, including poor communication, inadequate physician
time spent per patient, and patients' underreporting of symptoms to physicians. Thus,
incorporation of PRO data into routine clinical care can facilitate better detection and
management of cancer and treatment-related effects.

Therefore, the goal of this pilot study is to move PRO data collection from a purely research
exercise into using this as a tool to improve care for cancer patients. This pilot study will
assess the feasibility of collecting PRO data as part of clinical care, and assess its
value" from the patient and physician perspectives. The investigators will recruit 80
patients with prostate or bladder cancers from the UNC Genitourinary Oncology clinics
(including Urology and Radiation Oncology). PRO data that is most relevant to this patient
population will be collected, including: gastrointestinal, urinary, sexual function,
anxiety/depression, and sleep.

Further, given longstanding racial disparities in symptom experiences (e.g., symptom
assessment, severity, frequency) among cancer patients and limited evidence of effective
strategies for mitigating such inequities, this pilot study will also examine Black-White
differences in terms of the feasibility and perceived value of sharing of patient-reported
data to improve communication and decision-making.

Overal Status Start Date Phase Study Type
Recruiting May 8, 2017 N/A Observational

Primary Outcomes:

Primary Outcome 1 - Measure: Feasibility of PRO assessments in a clinical setting

Primary Outcome 1 - Time Frame: 90 days post treatment


  • Prostate Cancer
  • Bladder Cancer


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.
Show More

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Ronald Chen, MD

Role: Principal Investigator

Affiliation: University of North Carolina, Chapel Hill

Overall Contact

Name: Zahra Mahbooba, BA

Phone: 984-974-8744


Link: UNC Lineberger Comprehensive Cancer Center Clinical Trials


Facility Status Contact
NC Cancer Hospital
Chapel Hill, North Carolina 27599
United States
Recruiting Zahra Mahbooba, BA