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Prostate CancerNCT03156244

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

An observational study of Prostate Cancer and Bladder Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Prostate Cancer, Bladder Cancer
How many people
80 participants
Where
1 siteUnited States
Study dates
8 May 2017to 5 May 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Becky Green

    Chapel Hill, North Carolina, 27599

Other trials in United States

About this study

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

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.

Read the 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.

Keywords
PROMIS
Medical subject headings
Prostatic Neoplasms, Urinary Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03156244
Study groupRoleWhat they receive
CaucasianThis cohort will consist of 40 white patients who are receiving either radiation or surgery for treatment of their prostate or bladder cancer.
African AmericanThis cohort will consist of 40 African American patients who are receiving either radiation or surgery for treatment of their prostate or bladder cancer.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 90 days post treatment

Secondary outcomes (4)
  1. 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.

    Measured: baseline

  2. 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.

    Measured: baseline through 90 days post treatment

  3. 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.

    Measured: baseline through 90 days post treatment

  4. Perceived value

    Patterns and Black vs. White differences in the perceived value of PRO assessments from the patient's perspective using semi-structured interviews.

    Measured: baseline through 90 days post treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 May 2017
  2. Study start8 May 2017
  3. Primary completion5 May 2018
  4. Study completion5 May 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03156244
Sponsor's protocol ID
LCCC1636
Status last verified
Sep 2019
First submitted
15 May 2017
Last updated
4 Nov 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No plan to make IPD available to other researchers

Questions about this trial

What is this clinical trial studying?

An observational study of Prostate Cancer and Bladder Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of PRO assessments in a clinical setting (time frame: 90 days post treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2019.

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