ePRO Questionnaires for Colorectal Cancer Symptom Management
Recruiting in Palo Alto (17 mi)
Overseen byNancy A Nixon, M.D.
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: AHS Cancer Control Alberta
Must be taking: Chemotherapy
Disqualifiers: No internet, Psychiatric disorders, others
Stay on Your Current Meds
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?This trial uses an online system for cancer patients to report their symptoms. Nurses are alerted to help patients with severe symptoms early, while those with mild symptoms get self-care advice. This aims to improve symptom management during treatment.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the ePRO questionnaires treatment for colorectal cancer symptom management?
Research shows that using electronic patient-reported outcomes (ePRO) in cancer care can improve patient satisfaction, quality of life, and survival. These benefits have been observed in various cancer types, suggesting that ePRO questionnaires could be effective for managing symptoms in colorectal cancer as well.
12345Is it safe to use ePRO questionnaires for managing symptoms in cancer patients?
The use of electronic patient-reported outcomes (ePRO) systems in cancer care has been shown to improve patient satisfaction, quality of life, and survival, suggesting they are generally safe for use in humans.
23567How is the ePRO questionnaire treatment different from other treatments for colorectal cancer?
The ePRO questionnaire treatment is unique because it uses electronic systems to allow patients to report their symptoms and quality of life directly, which can improve communication with healthcare providers and enhance symptom management. Unlike traditional treatments, it focuses on real-time monitoring and patient engagement, potentially leading to better quality of life and survival outcomes.
23489Eligibility Criteria
This trial is for men and women over 18 with early-stage breast or colorectal cancer starting systemic therapy after surgery. Participants must speak English, have internet access, a computer at home, and be willing to use an online portal for surveys.Inclusion Criteria
Participants or their caregivers will need to have a computer and internet access at home and be willing to learn to use and enter data via the web-based portal (REDCap).
I am over 18 and have early stage breast or colorectal cancer, starting treatment after surgery.
For the purposes of the current study, fluency and literacy in English will be required.
+1 more
Exclusion Criteria
I have early-stage breast or colorectal cancer and am not on chemotherapy.
Inability to complete or enter data on the REDCap system.
You don't have a computer or internet at home.
+2 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo neoadjuvant/adjuvant chemotherapy with regular ePROs and symptom management
6 months
Regular clinic visits prior to each chemotherapy appointment
Follow-up
Participants are monitored for safety and effectiveness after treatment using ePROs and HRQOL questionnaires
6 months
Scheduled clinic visits and telephone assessments
Long-term follow-up
Assessment of quality of life and patient satisfaction at the end of the study
within 1 year
Participant Groups
The study compares the effectiveness of using electronic patient-reported outcome questionnaires (ePROs) with targeted symptom management against standard care during neoadjuvant/adjuvant therapy in a single-center randomized trial.
2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
Participants in the intervention group will also have a planned clinic follow-up visit prior to each scheduled chemotherapy appointment. They will be asked to complete a series of HRQOL questionnaires at baseline, at 6 months, and at completion of neoadjuvant/adjuvant chemotherapy to evaluate their HRQOL and satisfaction levels with their care. In addition, however, they will also receive an email reminder at the mid-way point between scheduled clinic visits to prompt them to enter ePROs via the REDCap online system, including measures such as the ESASr, the EORTC-QLQ C30 and EORTC-BR23 or EORTC-CR29 and specific symptom questionnaires.
Group II: Control groupActive Control1 Intervention
Participants in the control group will have a planned clinic follow-up visit prior to each scheduled chemotherapy appointment. Although they will not be asked to complete PROs in between clinic visits, they will be asked to respond to a series of HRQOL questionnaires at baseline, at 6 months (±2 weeks) from enrollment, and at completion of neoadjuvant/adjuvant systemic therapy if this date differs from the 6-month time point by more than 4 weeks. A satisfaction questionnaire will also be administered at the end of study.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Tom Baker Cancer CentreCalgary, Canada
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Who Is Running the Clinical Trial?
AHS Cancer Control AlbertaLead Sponsor
Tom Baker Cancer CentreCollaborator
References
Analysis of a Remote Monitoring Program for Symptoms Among Adults With Cancer Receiving Antineoplastic Therapy. [2022]Electronic patient-reported outcomes (ePROs) may have the potential to improve cancer care delivery by enhancing patient quality of life, reducing acute care visits, and extending overall survival. However, the optimal cadence of ePRO assessments is unknown.
The Effect of Collaborative Reviews of Electronic Patient-Reported Outcomes on the Congruence of Patient- and Clinician-Reported Toxicity in Cancer Patients Receiving Systemic Therapy: Prospective, Multicenter, Observational Clinical Trial. [2021]Electronic patient-reported outcomes (ePRO) are a relatively novel form of data and have the potential to improve clinical practice for cancer patients. In this prospective, multicenter, observational clinical trial, efforts were made to demonstrate the reliability of patient-reported symptoms.
How Should Oncologists Choose an Electronic Patient-Reported Outcome System for Remote Monitoring of Patients With Cancer? [2021]Electronic patient-reported outcome (ePRO) systems for symptom monitoring in patients with cancer have shown quality of life and survival benefits in controlled trials. They are beginning to be used in routine oncology practice. Many software developers provide software solutions for clinicians, but how should clinicians decide which system to use? We propose a synthesis of the main questions regarding the effectiveness, safety, and functionality of an ePRO system that a clinician should ask software providers to assist in the selection of a software product in order to obtain the best value tools for their patients and their practice.
Longitudinal study of symptom burden in outpatients with advanced cancers based on electronic Patient-Reported Outcome (ePRO) platform: a single institution, prospective study protocol. [2021]An electronic Patient-Reported Outcome (ePRO) platform is needed for implementing evidence-based symptom management in outpatients with advanced cancer. We describe the overall protocol and the methodology for measuring symptom burden, to provide critical parameters needed to implement symptom management on the ePRO platform.
Collection of electronic patient-reported symptoms in patients with advanced cancer using Epic MyChart surveys. [2020]Use of electronic patient-reported outcomes (ePROs) in routine cancer care can help identify troublesome symptoms and facilitate discussions between patients and clinicians and has been shown to improve patient satisfaction, quality of life, and survival.
Effect of Collaborative Review of Electronic Patient-Reported Outcomes for Shared Reporting in Breast Cancer Patients: Descriptive Comparative Study. [2021]Digital monitoring of treatment-related symptoms and self-reported patient outcomes is important for the quality of care among cancer patients. As mobile devices are ubiquitous nowadays, the collection of electronic patient-reported outcomes (ePROs) is gaining momentum. So far, data are lacking on the modalities that contribute to the quantity and quality of ePROs.
A Narrative Review on the Collection and Use of Electronic Patient-Reported Outcomes in Cancer Survivorship Care with Emphasis on Symptom Monitoring. [2023]Electronic patient-reported outcome (ePRO) applications promise great added value for improving symptom management and health-related quality of life. The aim of this narrative review is to describe the collection and use of ePROs for cancer survivorship care, with an emphasis on ePRO-symptom monitoring. It offers many different perspectives from research settings, while current implementation in routine care is ongoing. ePRO collection optimizes survivorship care by providing insight into the patients' well-being and prioritizing their unmet needs during the whole trajectory from diagnosis to end-of-life. ePRO-symptom monitoring can contribute to timely health risk detection and subsequently allow earlier intervention. Detection is optimized by automatically generated alerts that vary from simple to complex and multilayered. Using ePRO-symptoms during in-hospital consultation enhances the patients' conversation with the health care provider before making informed decisions about treatments, other interventions, or self-management. ePRO(-symptoms) entail specific implementation issues and complementary ethics considerations. The latter is due to privacy concerns, digital divide, and scarcity of adequately representative data for particular groups of patients.
Understanding patient-reported outcome measures in colorectal cancer. [2019]Quality of life has become increasingly regarded as a key outcome measurement for cancer patients. Patient-reported outcome measures (PROMs) represent the tools used to ascertain self-reported quality of life. This review provides a summary of the literature regarding the use of PROMs in colorectal cancer and evaluates the advantages and limitations of generic and disease specific questionnaires that can be utilized in clinical practice. Factors that influence PROMs are outlined, including cancer characteristics, patient factors and treatment methods. Finally, future directions for the use of PROMs in colorectal cancer to inform healthcare delivery at an individual- and systems-based level are discussed.
Electronic patient-reported outcome systems in oncology clinical practice. [2022]Patient-reported outcome (PRO) questionnaires assess topics a patient can report about his or her own health. This includes symptoms (eg, nausea, fatigue, diarrhea, pain, or frequent urination), physical functioning (eg, difficulty climbing stairs or difficulty fastening buttons), and mental health (eg, anxiety, fear, or worry). Electronic PRO (ePRO) systems are used in oncology clinical care because of 1) their ability to enhance clinical care by flagging important symptoms and saving clinicians time; 2) the availability of standardized methods for creating and implementing PROs in clinics; and 3) the existence of user-friendly platforms for patient self-reporting like tablet computers and automated telephone surveys. Many ePRO systems can provide actionable links to clinical care such as summary reports in a patient's electronic medical record and real-time e-mail alerts to providers when patients report acute needs. This review presents 5 examples of ePRO systems currently in use in oncology practice. These systems support multiple clinical activities, including assessment of symptoms and toxicities related to chemotherapy and radiation, postoperative surveillance, and symptom management during palliative care and hospice. Patient self-reporting is possible both at clinical visits and between visits over the Internet or by telephone. The implementation of an ePRO system requires significant resources and expertise, as well as user training. ePRO systems enable regular monitoring of patient symptoms, function, and needs, and can enhance the efficiency and quality of care as well as communication with patients.