Clinical trial NCT03156244: Using PROMIS as Part of Routine Clinical Care for Racially Diverse Prostate and Bladder Cancer Patients
Official title: LCCC 1636: Using PROMIS as Part of Routine Clinical Care for Racially Diverse Prostate and Bladder Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Bladder Cancer
Keywords: PROMIS
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2017-05-17
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility of PRO assessments in a clinical setting
timeFrame: 90 days post treatment
Secondary outcomes:
measure: Feasibility of enrollment
timeFrame: baseline
measure: Preferred mode of questionnaire completion
timeFrame: baseline through 90 days post treatment
measure: Feasibility by cohort
timeFrame: baseline through 90 days post treatment
measure: Perceived value
timeFrame: baseline through 90 days post treatment
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: Becky Green
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Ronald Chen, MD
role: PRINCIPAL_INVESTIGATOR
References: