ePRO Questionnaires for Colorectal Cancer Symptom Management

Recruiting at 1 trial location

Overseen By Michelle Kan

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: AHS Cancer Control Alberta

Must be taking: Chemotherapy

Disqualifiers: No internet, Psychiatric disorders, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

128 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 3 6 7 8}

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. ^{1 3 4 7 9}

Who Is on the Research Team?

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.

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?

Group I: Intervention Experimental Treatment 1 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 group Active Control 1 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.

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How Should Oncologists Choose an Electronic Patient-Reported Outcome System for Remote Monitoring of Patients With Cancer? Denis, F., Krakowski, I.[2021]

The study focuses on using an electronic Patient-Reported Outcome (ePRO) platform to measure and manage symptom burden in outpatients with advanced cancers, including lung, stomach, and breast cancer, with the primary goal of assessing changes in symptom burden over time.

The methodology includes using various validated symptom assessment tools and sending automated follow-up notifications to patients over 4 weeks, aiming to evaluate the feasibility of the ePRO system in tracking symptoms and improving patient quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Longitudinal study of symptom burden in outpatients with advanced cancers based on electronic Patient-Reported Outcome (ePRO) platform: a single institution, prospective study protocol. Tang, L., Pang, Y., He, Y., et al.[2021]

The use of electronic patient-reported outcomes (ePROs) in cancer care significantly improved communication between patients and clinicians, with 66% of patients completing symptom surveys, indicating a high level of engagement.

Monitoring symptoms in real time through ePROs helped identify severe symptoms in 36% of surveys, allowing for timely management, and both patients and clinicians found the system efficient and beneficial for routine oncology care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Collection of electronic patient-reported symptoms in patients with advanced cancer using Epic MyChart surveys. Zylla, DM., Gilmore, GE., Steele, GL., et al.[2020]

The study compared two versions of a mobile app for monitoring cancer patients' symptoms, finding that version 2 significantly increased the number of daily data entries for well-being (0.3 to 1.0) and symptoms (1.3 to 1.9), indicating improved engagement.

Version 2 of the app, which included a feature for collaborative patient-doctor symptom reviews, resulted in 628 out of 872 intended reviews being completed, suggesting that this collaborative approach enhances the quality of data collected and the patient-doctor experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Collaborative Review of Electronic Patient-Reported Outcomes for Shared Reporting in Breast Cancer Patients: Descriptive Comparative Study. Trojan, A., Bättig, B., Mannhart, M., et al.[2021]

Electronic patient-reported outcome (ePRO) applications can significantly enhance cancer survivorship care by monitoring symptoms and providing insights into patients' well-being, which helps identify unmet needs throughout their treatment journey.

ePRO-symptom monitoring facilitates timely health risk detection and allows for earlier interventions, improving communication between patients and healthcare providers during consultations, although there are important ethical considerations regarding privacy and data representation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Narrative Review on the Collection and Use of Electronic Patient-Reported Outcomes in Cancer Survivorship Care with Emphasis on Symptom Monitoring. van den Hurk, CJG., Mols, F., Eicher, M., et al.[2023]

Patient-reported outcome measures (PROMs) are essential tools for assessing the quality of life in colorectal cancer patients, highlighting the importance of self-reported data in understanding patient experiences.

The review discusses the advantages and limitations of both generic and disease-specific questionnaires, emphasizing the need for tailored approaches in clinical practice to better inform healthcare delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Understanding patient-reported outcome measures in colorectal cancer. Besson, A., Deftereos, I., Chan, S., et al.[2019]

Electronic Patient-Reported Outcome (ePRO) systems in oncology improve clinical care by allowing patients to report symptoms and health status, which helps clinicians identify urgent needs and manage care more effectively.

These systems facilitate ongoing monitoring of patient symptoms and functioning, enhancing communication between patients and healthcare providers, although their implementation requires significant resources and training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electronic patient-reported outcome systems in oncology clinical practice. Bennett, AV., Jensen, RE., Basch, E.[2022]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Analysis of a Remote Monitoring Program for Symptoms Among Adults With Cancer Receiving Antineoplastic Therapy. [2022]

2. Canada pubmed.ncbi.nlm.nih.gov

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]

3. Canada pubmed.ncbi.nlm.nih.gov

How Should Oncologists Choose an Electronic Patient-Reported Outcome System for Remote Monitoring of Patients With Cancer? [2021]

4. England pubmed.ncbi.nlm.nih.gov

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]

5. Germany pubmed.ncbi.nlm.nih.gov

Collection of electronic patient-reported symptoms in patients with advanced cancer using Epic MyChart surveys. [2020]

6. Canada pubmed.ncbi.nlm.nih.gov

Effect of Collaborative Review of Electronic Patient-Reported Outcomes for Shared Reporting in Breast Cancer Patients: Descriptive Comparative Study. [2021]

7. Switzerland pubmed.ncbi.nlm.nih.gov

A Narrative Review on the Collection and Use of Electronic Patient-Reported Outcomes in Cancer Survivorship Care with Emphasis on Symptom Monitoring. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Understanding patient-reported outcome measures in colorectal cancer. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Electronic patient-reported outcome systems in oncology clinical practice. [2022]