Patient-Reported Data Tracking for Cancer
Recruiting in Palo Alto (17 mi)
Overseen byKatie Reeder-Hayes
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: UNC Lineberger Comprehensive Cancer Center
Disqualifiers: No email, No smartphone, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This study assesses the feasibility and acceptability of a brief electronic patient-reported outcome (ePRO) tool that allows patients to self-identify impending delays. The risk of treatment delays according to tumor type and race will be measured by both ePRO and electronic health record (EHR) tools. Data from this study and the association of social determinants of health could be useful to flag patients at risk of delay and due timely intervention for modifiable treatment barriers. The prediction of the risk of treatment delay will be helpful to design another study using electronic tracking systems to prevent cancer treatment delays. The long-term goal of this research is to alert care teams when patients may be at risk of treatment days and to help patients get treatment faster. It was planned to enroll a total of 240 subjects with newly diagnosed cancer. Sixty colorectal and 180 breast cancer patients will be included.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the treatment Weekly Survey for cancer?
Research suggests that using patient-reported data, like weekly surveys, can improve the care process in cancer treatment by helping detect symptoms early and facilitating timely interventions, although it may not directly improve patient outcomes like quality of life.
12345Is the patient-reported data tracking for cancer treatment safe for humans?
The patient-reported data tracking system, known as PRO-CTCAE, is designed to improve the reporting of side effects during cancer treatment. It has been positively received by stakeholders for its potential to enhance the accuracy and completeness of symptom data, which can help in making better treatment decisions and improving patient safety.
678910How does this treatment differ from other cancer treatments?
This treatment is unique because it involves real-time tracking of patient-reported outcomes (PROs) using familiar technology like social media apps and smartphones, which helps patients manage symptoms better and communicate more effectively with clinicians. Unlike traditional methods that rely on retrospective data, this approach provides immediate feedback and enhances patient engagement in their own care.
1112131415Eligibility Criteria
This trial is for adults over 18 with a recent diagnosis of breast or colorectal cancer who plan to receive treatment at the University of North Carolina. They must be able to get and respond to surveys electronically and give consent. Those without email or smartphone access, unable to consent, or not fluent in English cannot join.Inclusion Criteria
I am over 18 years old.
I have not started any cancer treatment yet.
I was diagnosed with breast or colorectal cancer in the last 6 weeks.
+1 more
Exclusion Criteria
Patient cannot read and speak English
I am unable or unwilling to receive and complete surveys electronically.
Patient unwilling or unable to provide verbal or signed consent to participate
+1 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Data Collection
Participants complete weekly electronic patient-reported outcome (ePRO) questionnaires to identify treatment delays
8 weeks
Weekly electronic surveys
Follow-up
Participants are monitored for treatment initiation and delays using ePRO and EHR tools
8 weeks
Analysis and Reporting
Data from ePRO and EHR are analyzed to assess treatment delays and racial disparities
4 weeks
Participant Groups
The study tests an electronic tool where patients report issues that might delay their cancer treatment. It aims to identify if there's a link between race, social factors, and treatment delays using patient feedback and health records.
1Treatment groups
Experimental Treatment
Group I: electronic patient-reported outcome (ePRO) questionnaires.Experimental Treatment1 Intervention
Subjects with colon or breast carcinoma will respond to weekly electronic patient-reported outcome (ePRO) questionnaires.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of North CarolinaChapel Hill, NC
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Who Is Running the Clinical Trial?
UNC Lineberger Comprehensive Cancer CenterLead Sponsor
References
Evaluating the quality of supportive oncology using patient-reported data. [2022]Patient-reported data may provide valuable information for oncology quality measurement. We evaluated applying patient-reported data from the Cancer Care Outcomes Research and Surveillance Consortium national study to quality indicators addressing supportive oncology domains.
Effectiveness of routine provision of feedback from patient-reported outcome measurements for cancer care improvement: a systematic review and meta-analysis. [2023]Research shows that feeding back patient-reported outcome information to clinicians and/or patients could be associated with improved care processes and patient outcomes. Quantitative syntheses of intervention effects on oncology patient outcomes are lacking.
Improving patient outcomes through the routine use of patient-reported data in cancer clinics: future directions. [2022]Recent reviews suggest that the routine use of patient-reported outcome measures (PROMs) in cancer clinics improves the processes of care but not patient outcomes such as quality of life or satisfaction. We set out to identify future strategies for (1) interventions to impact patient outcomes and (2) trials to identify treatment effects.
Evaluation of an individual feedback report on patient-reported outcomes in the Prospective Dutch ColoRectal Cancer cohort. [2022]Returning patient-reported outcomes to patients might aid patients in detecting symptoms and might facilitate early intervention. This descriptive study evaluates the use of an individual feedback report on patient-reported outcomes for colorectal cancer patients and aims to assess differences in patient, tumor, and treatment characteristics and cohort retention between patients who opt and do not opt for the feedback report.
Listening to the Patient Voice Adds Value to Cancer Clinical Trials. [2023]Randomized clinical trials are critical for evaluating the safety and efficacy of interventions in oncology and informing regulatory decisions, practice guidelines, and health policy. Patient-reported outcomes (PROs) are increasingly used in randomized trials to reflect the impact of receiving cancer therapies from the patient perspective and can inform evaluations of interventions by providing evidence that cannot be obtained or deduced from clinicians' reports or from other biomedical measures. This commentary focuses on how PROs add value to clinical trials by representing the patient voice. We employed 2 previously published descriptive frameworks (addressing how PROs are used in clinical trials and how PROs have an impact, respectively) and selected 9 clinical trial publications that illustrate the value of PROs according to the framework categories. These include 3 trials where PROs were a primary trial endpoint, 3 trials where PROs as secondary endpoints supported the primary endpoint, and 3 trials where PROs as secondary endpoints contrast the primary endpoint findings in clinically important ways. The 9 examples illustrate that PROs add valuable data to the care and treatment context by informing future patients about how they may feel and function on different treatments and by providing clinicians with evidence to support changes to clinical practice and shared decision making. Beyond the patient and clinician, PROs can enable administrators to consider the cost-effectiveness of implementing new interventions and contribute vital information to policy makers, health technology assessors, and regulators. These examples provide a strong case for the wider implementation of PROs in cancer trials.
Stakeholder perspectives on implementing the National Cancer Institute's patient-reported outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). [2022]The National Cancer Institute (NCI) is developing a patient-reported version of its Common Terminology Criteria for Adverse Events, called the "PRO-CTCAE." The PRO-CTCAE consists of a library of patient-reported items which can be administered in clinical trials to directly capture the patient experience of adverse events during cancer treatment, as well as a software platform for administering these items via computer or telephone. In order to better understand the impressions of stakeholders involved in cancer clinical research about the potential value of the PRO-CTCAE approach to capturing adverse event information in clinical research, as well as their perspectives about barriers and strategies for implementing the PRO-CTCAE in NCI-sponsored cancer trials, a survey was conducted. A survey including structured and open-ended questions was developed to elicit perceptions about the use of patient-reported outcomes (PROs) for adverse event reporting, and to explore logistical considerations for implementing the PRO-CTCAE in cancer trials. The survey was distributed electronically and by paper to a convenience sample of leadership and committee members in the NCI's cooperative group network, including principal investigators, clinical investigators, research nurses, data managers, patient advocates, and representatives of the NCI and Food and Drug Administration. Between October, 2008 through February, 2009, 727 surveys were collected. Most respondents (93%) agreed that patient reporting of adverse symptoms would be useful for improving understanding of the patient experience with treatment in cancer trials, and 88%, 80%, and 76%, respectively, endorsed that administration of PRO-CTCAE items in clinical trials would improve the completeness, accuracy, and efficiency of symptom data collection. More than three fourths believed that patient reports would be useful for informing treatment dose modifications and towards FDA regulatory evaluation of drugs. Eighty-eight percent felt that patients in clinical trials would be willing to self-report adverse symptoms at clinic visits via computer, and 68% felt patients would self-report weekly from home via the internet or an automated telephone system. Lack of computers and limited space and personnel were seen as potential barriers to in-clinic self-reporting, but these were judged to be surmountable with adequate funding. The PRO-CTCAE items and software are viewed by a majority of survey respondents as a means to improve adverse event data quality and comprehensiveness, enhance clinical decision-making, and foster patient-clinician communication. Research is ongoing to assess the measurement properties and feasibility of implementing this measure in cancer clinical trials.
Cognitive interviewing of the US National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). [2022]The National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) is a library of question items that enables patient reporting of adverse events (AEs) in clinical trials. This study contributes content validity evidence of the PRO-CTCAE by incorporating cancer patient input of the relevance and comprehensiveness of the item library.
How accurate is clinician reporting of chemotherapy adverse effects? A comparison with patient-reported symptoms from the Quality-of-Life Questionnaire C30. [2022]Adverse events in chemotherapy clinical trials are assessed and reported by clinicians, yet clinician accuracy in assessing symptoms has been questioned. We compared patient reporting of eight symptoms using a validated instrument, the European Organization for the Research and Treatment of Cancer Quality-of-Life Questionnaire C30 (QLQ-C30 or QLQ) with physicians' reporting of the same symptoms in the study's adverse events log.
Digitalization of adverse event management in oncology to improve treatment outcome-A prospective study protocol. [2021]The occurrence of adverse events frequently accompanies tumor treatments. Side effects should be detected and treated as soon as possible to maintain the best possible treatment outcome. Besides the standard reporting system Common Terminology Criteria for Adverse Events (CTCAE), physicians have recognized the potential of patient-reporting systems. These are based on a more subjective description of current patient reporting symptoms. Patient-reported symptoms are essential to define the impact of a given treatment on the quality of life and the patient's wellbeing. They also act against an underreporting of side effects which are paramount to define the actual value of a treatment for the individual patient. Here, we present a study protocol for a clinical trial that assesses the potential of a smartphone application for CTCAE conform symptom reporting and tracking that is adjusted to the standard clinical reporting system rather than symptom oriented descriptive trial tools. The presented study will be implemented in two parts, both lasting over six months. The first part will assess the feasibility of the application with 30 patients non-randomly divided into three equally-sized age groups (75years). In the second part 36 other patients will be randomly assigned to two groups, one reporting using the smartphone and one not. This prospective second part will compare the impact of smartphone reported adverse events regarding applied therapy doses and quality of life to those of patients receiving standard care. We aim for early detection and treatment of adverse events in oncological treatment to improve patients' safety and outcomes. For this purpose, we will capture frequent adverse events of chemotherapies, immunotherapies, or other targeted therapies with our smartphone application. The presented trial is registered at the U.S. National Library of Medicine ClinicalTrials.gov (NCT04493450) on July 30, 2020.
Electronic toxicity monitoring and patient-reported outcomes. [2022]Understanding the potential profile of adverse events associated with cancer treatment is essential in balancing safety versus benefits. Multiple stakeholders make use of this information for decision making, including patients, clinicians, researchers, regulators, and payors. Currently, adverse events are reported by clinical research staff, yet evidence suggests that this may contribute to underreporting of symptom events. Direct patient reporting via electronic interfaces offers a promising mechanism to enhance the efficiency and precision of our current approach and may complement clinician reports of adverse events. The National Cancer Institute has contracted to develop and test an item bank and software system for directly eliciting adverse symptom event information from patients in cancer clinical research, called the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events. The validity, usability, and scalability of the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events prototype are currently being examined in academic and community-based settings.
Acceptability of a Touch Screen Tablet Psychosocial Survey Administered to Radiation Therapy Patients in Japan. [2018]Studies in western clinical settings suggest that touch screen computer surveys are an acceptable mode of collecting information about cancer patients' wellbeing
Feasibility study on collecting patient-reported outcomes from breast cancer patients using the LINE-ePRO system. [2022]Due to the increasing complexity of cancer treatment, ensuring safety and maintaining the quality of life during treatment are important issues. Patient-reported outcomes (PROs) in oncology are essential for assessing patient symptoms. A feasibility study was undertaken on breast cancer patients by building a PRO data collection system based on LINE, one of the most popular social network service applications in Japan. In this study, one or more predefined PRO questions for each breast cancer patient's clinical situation were sent to the patient's LINE application daily. The patient selected a predefined answer by tapping the screen, but no free-text answers were allowed. Seventy-three patients were enrolled. The median observation period was 435 days (84-656 days), and the total number of PROs collected was 16,417, with a mean of 224.9 reports per patient. Patients on adjuvant endocrine therapy were notified of 2.5 questions per week, and the median number of responses per week and response rate were 2.387 (1.687-11.627) and 95.5%, respectively. Analyzing the results by age group, the number of responses from those aged 60 and above was equal to or higher than that of the younger age group. It was also possible to track each patient's PROs accurately. These results suggested that the design of the system, based on an application used daily, instead of using specifically prepared applications for collecting electronic PROs, was the reason for the favorable acceptance from patients and the satisfactory response rate from all age groups, including the elderly.
Design and feasibility of integrating personalized PRO dashboards into prostate cancer care. [2018]Patient-reported outcomes (PROs) are a valued source of health information, but prior work focuses largely on data capture without guidance on visual displays that promote effective PRO use in patient-centered care. We engaged patients, providers, and design experts in human-centered design of "PRO dashboards" that illustrate trends in health-related quality of life (HRQOL) reported by patients following prostate cancer treatment.
Smartphone Sensors for Monitoring Cancer-Related Quality of Life: App Design, EORTC QLQ-C30 Mapping and Feasibility Study in Healthy Subjects. [2023]Quality of life (QoL) indicators are now being adopted as clinical outcomes in clinical trials on cancer treatments. Technology-free daily monitoring of patients is complicated, time-consuming and expensive due to the need for vast amounts of resources and personnel. The alternative method of using the patients' own phones could reduce the burden of continuous monitoring of cancer patients in clinical trials. This paper proposes monitoring the patients' QoL by gathering data from their own phones. We considered that the continuous multiparametric acquisition of movement, location, phone calls, conversations and data use could be employed to simultaneously monitor their physical, psychological, social and environmental aspects. An open access phone app was developed (Human Dynamics Reporting Service (HDRS)) to implement this approach. We here propose a novel mapping between the standardized QoL items for these patients, the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and define HDRS monitoring indicators. A pilot study with university volunteers verified the plausibility of detecting human activity indicators directly related to QoL.
Probing the benefits of real-time tracking during cancer care. [2022]People with cancer experience many unanticipated symptoms and struggle to communicate them to clinicians. Although researchers have developed patient-reported outcome (PRO) tools to address this problem, such tools capture retrospective data intended for clinicians to review. In contrast, real-time tracking tools with visible results for patients could improve health outcomes and communication with clinicians, while also enhancing patients' symptom management. To understand potential benefits of such tools, we studied the tracking behaviors of 25 women with breast cancer. We provided 10 of these participants with a real-time tracking tool that served as a "technology probe" to uncover behaviors and benefits from voluntary use. Our findings showed that while patients' tracking behaviors without a tool were fragmented and sporadic, these behaviors with a tool were more consistent. Participants also used tracked data to see patterns among symptoms, feel psychosocial comfort, and improve symptom communication with clinicians. We conclude with design implications for future real-time tracking tools.