ctcae prostate cancer patient report outcomes

Purpose We report acute patient-reported outcomes using CTCAE (PRO-CTCAE) of proton beam radiotherapy for high-risk or unfavorable intermediate-risk prostate cancer in a prospective clinical trial. PRO-CTCAE were correlated with investigator reported-CTCAE (IR-CTCAE) to assess the degree of concordance.

Full Answer

When to use Patient-Reported Outcome measures (pro) in medical product development?

Refer to the guidance for industry Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims for situations where the PRO endpoint will be used as the primary evidence of effectiveness.

Can patient reporting improve the quality of side-effect data in trials?

"Patient reporting in various forms could improve the quality of side-effect data collection in clinical trials," said Dr. Basch. This is important in drug development, he explained, because if researchers miss or underestimate the severity of side effects caused by a drug they can inadvertently pick the wrong dose or the wrong treatment schedule.

Does the FDA endorse pro measures in clinical trials?

FDA does not endorse any specific PRO measure and examples within this document are illustrative and should not be construed as endorsements. This guidance is specific to registration trials for anti-cancer therapies intended to demonstrate an effect on survival, tumor response, or delay in the progression of a malignancy.

What is the latest version of CTCAE?

The current version 5.0 was released on November 27, 2017. Many clinical trials, now extending beyond oncology, encode their observations based on the CTCAE system.

What is CTCAE grading?

Grade refers to the severity of the AE. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.

What is a grade 5 adverse event?

Grades 5 are fatal adverse event resulting in death. Serious Adverse Events (SAE's) Clarification should be made between a serious AE (SAE) and an AE that is considered severe in intensity (Grade 3 or 4), because the terms serious and severe are NOT synonymous.

What is the pro CTCAE?

PRO-CTCAE is a patient-reported outcome (PRO) measurement system developed to evaluate symptomatic toxicity in patients on cancer clinical trials. It was designed to be used as a companion to the Common Terminology Criteria for Adverse Events (CTCAE)

What is CTCAE in oncology?

CTCAE stands for Common Terminology Criteria for Adverse Events; these criteria are also called "common toxicity criteria." In CTCAE, an adverse event (AE) is defined as any abnormal clinical finding temporally associated with the use of a therapy for cancer; causality is not required.

What is CTCAE v5?

Common Terminology Criteria. for Adverse Events (CTCAE) Version 5.0.

What qualifies as a serious adverse event?

Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, result in a persistent or significant disability/incapacity or result in a congenital anomaly/birth defect.

What are Grade 3 and 4 adverse events definition?

– Grade 3 Severe or medically significant but not immediately life- threatening; hospitalization or prolongation of hospitalization. indicated; disabling; limiting self care ADL. – Grade 4 Life-threatening consequences; urgent intervention indicated. – Grade 5 Death related to AE.

When do you consider an event to be serious?

An adverse event or suspected adverse reaction is considered "serious" if, in the view of either the investigator or sponsor, it results in any of the following outcomes: Death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant ...

How many side effects are there in CTCAE?

The team combed through the CTCAE to identify those adverse events that are amenable to self-reporting. They identified 78 symptomatic side effects that are associated with common treatments, including chemotherapy, radiation therapy, biological therapy, and immunotherapy, explained Sandra Mitchell, Ph.D., program director in NCI's Outcomes Research Branch and current scientific lead for PRO-CTCAE development. A library of questions phrased using plain, patient-friendly language was developed to capture these side effects directly from patients, Dr. Mitchell continued.

What is the PRO-CTCAE system?

Researchers at NCI and at cancer centers across the United States set out to build a version of the CTCAE system to be used for self-reporting of symptomatic side effects by patients, called the PRO-CTCAE.

Why do we use CTCAE?

As part of their standard patient assessments, staff involved in trials use the CTCAE system to record any side effects patients are experiencing. But researchers have long wondered if creating a way for patients to document their own experiences during treatment would help to provide more complete and accurate information about symptomatic side effects that may be associated with new drugs or treatment regimens.

Why are patient reports not collected?

Overall, patient-reported outcomes were successfully collected at 86% of scheduled visits. The most common reasons that the data could not be collected were missed clinic appointments, simple oversights (such as forgetting to provide tablet computers to participants), and technical problems (such as computer malfunctions or Internet connectivity issues). Only 13% of missed reports occurred because patients felt too sick to fill out the forms.

What is CTCAE in clinical trials?

This tool allows reports on everything from blood test values to toothaches. It also includes many symptoms—such as nausea, anxiety, and nerve pain—that are by their nature personal and difficult for an observer to measure.

Why are there gaps in patient outcomes?

The study, in fact, found that most gaps in these patient-reported outcomes data—which were captured during clinic visits using tablet computers—weren't caused by patients feeling too ill to provide reports. Instead, they were due largely to technical errors like lost Internet connectivity.

How long do you have to stop taking breast cancer drugs?

As a result, up to 40% of women "stop taking the drugs very soon after starting, and another 20% will stop taking them within the first year or two," he said, rather than taking them for the recommended 5- or 10-year course.

Does radiotherapy affect urinary function?

The negative effect of radiotherapy on sexual function was greatest at 6 months, but sexual function then recovered somewhat and was stable thereafter; radiotherapy had little effect on urinary continence. Sexual and urinary function declined gradually in the active-monitoring group. Bowel function was worse in the radiotherapy group ...

Does bowel function decline with radiotherapy?

Sexual and urinary function declined gradually in the active-monitoring group. Bowel function was worse in the radiotherapy group at 6 months than in the other groups but then recovered somewhat, except for the increasing frequency of bloody stools; bowel function was unchanged in the other groups.

What is PRO-CTCAE?

The PRO-CTCAE has been implemented in multiple cancer clinical trials. Patients are generally willing and able to self-report this information weekly via the web or automated telephone systems though electronic reminders; central monitoring and personnel for backup data collection were also needed to optimize response rates. Clinicians note finding this information to be meaningful and valuable for clinical decision-making and AE reporting. 23

What is the purpose of PRO-CTCAE?

The PRO-CTCAE measurement system has been developed by NCI as a companion to the CTCAE. It was designed to improve the validity, reliability, and precision with which symptomatic adverse effects of treatment are evaluated in patients on cancer clinical trials. PRO-CTCAE was developed by a multidisciplinary team of trialists, methodologists, clinicians, informatics experts, patients, and regulators 18 and has been tested and refined in a consortium of academic and community-based cancer-treatment sites and in the NCI-sponsored clinical trials network (NCI contracts HHSN261200800043C and HHSN261200800063C) and by more than 120 early adopters in 10 countries. The PRO-CTCAE item library consists of 124 discrete items representing 78 symptomatic AEs that are common in oncology clinical trials and included in the CTCAE. PRO-CTCAE items were created with substantial input from patients, clinicians, and PRO methodologists and underwent refinement through cognitive interviews with patients to establish content validity. 19 Subsequently, the quantitative measurement properties, including validity, reliability, and responsiveness, were evaluated in a large and diverse sample of patients receiving cancer treatment in six sites around the United States. 20

What languages are in the Pro-CTCAE library?

Although multiple translations are in progress (for example, Italian, Korean, Chinese, and Swedish), and linguistically validated language versions are available in Spanish, German, Japanese, and Danish, 25 - 27 translation and linguistic validation of the PRO-CTCAE item library in other languages is needed.

What is CTCAE grade?

Using CTCAE, AEs are graded on a scale from grade 1 to 5, in which, by convention, grade 5 is death, and grade 4 reflects toxicities that are life-threatening and warrant urgent intervention .

What is a pro strategy in oncology?

To date, the most common PRO strategy for oncology has been to assess the broad multidomain concept of health-related quality of life (HRQOL), utilizing instruments largely developed in a different therapeutic era. 3 - 5 These existing HRQOL measures have strengths, including translations across multiple languages and a familiarity with their use among the cancer therapeutic development community. Many instruments have also been expanded to include disease-specific modules in an effort to better capture disease- and treatment-related symptoms. 6, 7 Substantial data have been accumulated using many of these measures, and some offer the advantage of well-established cut scores, minimally important difference thresholds, and normative values that can aid in interpretation.

Do cancer patients participate in research?

Many patients with cancer are willing to play their part in research through answering questionnaires. Unless patients are very ill and/or have cognitive deficits, many patients with cancer like the opportunity to contribute to research, especially meaningful research that can improve care for patients in the future.

Is PRO data included in FDA labeling?

For this reason, PRO data have rarely been included in FDA labeling of cancer therapies. When PRO data have been included in the FDA product label for cancer products, it has predominantly relied on well-defined measures of specific symptoms or functional measures that relate directly to the disease under study. 8.

What is PRO measure in cancer?

Although this guidance focuses on patient-reported outcome (PRO) measures, some of these recommendations may be relevant to other clinical outcome assessments (i.e., clinician-reported outcome, observer-reported outcome, performance outcome) in cancer clinical trials. Recommendations supplement previous guidance on use of PRO measures in clinical trials by providing additional considerations specific to the cancer clinical trial setting. Guidance specific to PRO endpoints and details of analytic methods are not comprehensively covered. FDA does not endorse any specific PRO measure and examples within this document are illustrative and should not be construed as endorsements.

Does the FDA endorse pro measures?

FDA does not en dorse any specific PRO measure and examples within this document are illustrative and should not be construed as endorsements. This guidance is specific to registration trials for anti-cancer therapies intended to demonstrate an effect on survival, tumor response, or delay in the progression of a malignancy.