128 Participants Needed

ePRO Questionnaires for Colorectal Cancer Symptom Management

Recruiting at 1 trial location
MA
NA
KM
MK
Overseen ByMichelle Kan
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: AHS Cancer Control Alberta
Must be taking: Chemotherapy
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

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.

Is 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.12345

How 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.13678

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.13479

Who Is on the Research Team?

NA

Nancy A Nixon, M.D.

Principal Investigator

Arthur J.E. Child Comprehensive Cancer Centre

Are You a Good Fit for This Trial?

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).
For the purposes of the current study, fluency and literacy in English will be required.
Participant has provided informed consent prior to initiation of any study specific activities/procedures.

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.
See 2 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

  • Electronic Tumour-Specific Patient-Reported Outcomes (ePRO) questionnaires
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
Group II: Control groupActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

AHS Cancer Control Alberta

Lead Sponsor

Trials
188
Recruited
26,900+

Tom Baker Cancer Centre

Collaborator

Trials
30
Recruited
8,900+

Published Research Related to This Trial

Daily electronic patient-reported outcomes (ePROs) significantly improved symptom management for 217 cancer patients undergoing treatment, with over 50% of assessments generating alerts for moderate to severe symptoms.
The study found that red alerts (indicating severe symptoms) were often detected without prior warnings, and these alerts were linked to a higher likelihood of acute care visits, highlighting the importance of regular monitoring in improving patient outcomes.
Analysis of a Remote Monitoring Program for Symptoms Among Adults With Cancer Receiving Antineoplastic Therapy.Daly, B., Nicholas, K., Flynn, J., et al.[2022]
In a study involving 181 cancer patients, the agreement between patient-reported symptoms and physician assessments showed moderate reliability, particularly for symptoms reported within a week of review, indicating that electronic patient-reported outcomes (ePRO) can be a valuable tool in clinical practice.
The study found that shared monitoring of symptoms between patients and physicians can enhance understanding and management of symptoms, suggesting that integrating ePRO into cancer care may lead to better patient empowerment and timely interventions.
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.Trojan, A., Leuthold, N., Thomssen, C., et al.[2021]
Electronic patient-reported outcome (ePRO) systems have demonstrated benefits in quality of life and survival for cancer patients in controlled trials, indicating their potential effectiveness in routine oncology practice.
Clinicians should ask specific questions about the effectiveness, safety, and functionality of ePRO systems when selecting software solutions to ensure they choose the best tools for their patients.
How Should Oncologists Choose an Electronic Patient-Reported Outcome System for Remote Monitoring of Patients With Cancer?Denis, F., Krakowski, I.[2021]

Citations

Analysis of a Remote Monitoring Program for Symptoms Among Adults With Cancer Receiving Antineoplastic Therapy. [2022]
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]
How Should Oncologists Choose an Electronic Patient-Reported Outcome System for Remote Monitoring of Patients With Cancer? [2021]
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]
Collection of electronic patient-reported symptoms in patients with advanced cancer using Epic MyChart surveys. [2020]
Effect of Collaborative Review of Electronic Patient-Reported Outcomes for Shared Reporting in Breast Cancer Patients: Descriptive Comparative Study. [2021]
A Narrative Review on the Collection and Use of Electronic Patient-Reported Outcomes in Cancer Survivorship Care with Emphasis on Symptom Monitoring. [2023]
Understanding patient-reported outcome measures in colorectal cancer. [2019]
Electronic patient-reported outcome systems in oncology clinical practice. [2022]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security