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 explores whether electronic questionnaires for symptom reporting can manage colorectal cancer more effectively than standard follow-up methods. Participants will either complete these electronic questionnaires, known as Electronic Tumour-Specific Patient-Reported Outcomes (ePRO) questionnaires, between regular chemotherapy visits or follow the usual care routine. The trial aims to determine if this new method improves patients' perceptions of their treatment and their quality of life. Individuals with early-stage colorectal cancer, who are beginning chemotherapy after surgery, and have access to a computer and internet at home may be suitable for this trial. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance patient care and quality of life.

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 prior data suggests that the ePRO questionnaires are safe for colorectal cancer symptom management?

Research shows that Electronic Tumour-Specific Patient-Reported Outcomes (ePRO) questionnaires are safe for patients. These ePROs enable patients to report symptoms directly, allowing healthcare providers to address issues promptly. Studies find that patients generally appreciate using ePROs, and they typically don't experience negative effects. Since this method involves electronic surveys rather than medication or surgery, the risks remain very low. Overall, ePROs provide a safe way to track symptoms and enhance patient care during cancer treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ePRO questionnaires for colorectal cancer symptom management because they aim to enhance patient involvement and optimize care in a unique way. Unlike traditional treatments that focus solely on medication and clinical visits, this approach leverages technology to actively engage patients through electronic reports. By prompting patients to report their symptoms and quality of life between clinic visits, it allows for more personalized care and timely adjustments in treatment. This method could lead to improved patient satisfaction and potentially better health outcomes by ensuring that care is responsive to the patient's current condition.

What evidence suggests that ePRO questionnaires are effective for colorectal cancer symptom management?

Research has shown that electronic questionnaires, known as Tumour-Specific Patient-Reported Outcomes (ePROs), can help cancer patients manage their symptoms more effectively. In this trial, participants in the intervention group will use ePROs to report their symptoms and quality of life, aiding doctors in making better treatment decisions. One study found that more than half of the participants experienced significant improvements in managing their symptoms with ePROs. Early results suggest that ePROs enhance communication between patients and healthcare providers, leading to better care. Overall, ePROs are promising tools for improving symptom management in cancer treatment. ^{1 2 3 6 7}

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

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]

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]

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 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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11700045/

Electronic patient-reported outcomes as digital ... Patient-reported outcomes (PROs) help assess the quality of life because they involve direct evaluation of the patients. Recently, electronic ...

2. withpower.com withpower.com/trial/phase-3-colorectal-neoplasms-9-2021-00f8e

ePRO Questionnaires for Colorectal Cancer Symptom ... Daily electronic patient-reported outcomes (ePROs) significantly improved symptom management for 217 cancer patients undergoing treatment, with over 50% of ...

3. ascopubs.org ascopubs.org/doi/10.1200/OP.24.00050

Electronic Patient-Reported Outcome-Driven Symptom ... We developed and implemented an electronic patient-reported outcome (ePRO)–driven symptom management tool led by oncology pharmacists in a majority-minority ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04990895/a-research-study-to-collect-patient-reported-outcomes-using-electronic-surveys

A Research Study to Collect Patient Reported Outcomes ... A single-centre, randomized, 2-arm clinical trial comparing follow-up consisting of tumour-specific Electronic Patient-Reported Outcomes ...

5. jmir.org jmir.org/2024/1/e49089/

Examining the Effectiveness of Electronic Patient-Reported ... The aim of this study was to compare the isolated effect of administering ePROs to patients with cancer versus a control condition.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04684095

The Effect of ePRO on Quality of Life and Prognosis ... Patient-Reported Outcomes (PROs) are a kind of outcome indicators that directly measure and evaluate the disease and its consequences based on how the patient ...

7. academic.oup.com academic.oup.com/jjco/article/55/5/547/8030580

Multicenter, open-label, randomized, controlled study to test ... This study examines whether adding ePRO monitoring to routine chemotherapy care improves survival and quality of life. Patients were randomized, and enroll.