Colorectal CancerNCT04990895
A Research Study to Collect Patient Reported Outcomes Using Electronic Surveys
A study testing Electronic Tumour-Specific Patient-Reported Outcomes (ePRO) questionnaires in people with Colorectal Cancer and Breast Cancer, run by AHS Cancer Control Alberta at 1 site in Canada.
Trial summary
A single-centre, randomized, 2-arm clinical trial comparing follow-up consisting of tumour-specific Electronic Patient-Reported Outcomes (ePROs) with targeted symptom management versus standard of care follow-up during neoadjuvant/adjuvant systemic therapy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Breast Cancer
- What is being tested?
- Electronic Tumour-Specific Patient-Reported Outcomes (ePRO) questionnaires
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteCanada
- Study dates
- 30 Mar 2022to 25 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant has provided informed consent prior to initiation of any study specific activities/procedures.
- Men or women ≥18 years old newly diagnosed early stage (stage I, II, or III) breast or colorectal cancer who initiate neoadjuvant/adjuvant systemic therapy after curative intent surgery.
- 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.
Who cannot join
- Lack of fluency or literacy of the English language.
- Lack of access to a computer or internet at home.
- Inability to complete or enter data on the REDCap system.
- Early-stage breast or colorectal cancer patients who are not receiving neoadjuvant/adjuvant chemotherapy (patients undergoing adjuvant hormonal or targeted therapy alone without chemotherapy will be excluded).
- Has known psychiatric or substance abuse disorders that would interfere with compliance with the requirements of the trial.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Arthur J.E. Child Comprehensive Cancer Centre
Calgary, Alberta, T2N 5G2
About this study
Official title: A Randomized Clinical Trial of Electronic Tumour-Specific Patient-Reported Outcomes in Early-Stage Breast and Colorectal Cancer Patients Undergoing Neoadjuvant/Adjuvant Chemotherapy
A single-centre, randomized, 2-arm clinical trial comparing follow-up consisting of tumour-specific Electronic Patient-Reported Outcomes (ePROs) with targeted symptom management versus standard of care follow-up during neoadjuvant/adjuvant systemic therapy
Read the detailed description
The intervention in this study will consist of a web-based portal that leverages the existing data entry and reporting capacity of the REDCap (Research Electronic Data Capture) platform to prompt study participants to enter various health-related quality of life (HRQOL) and symptom measures online at regular intervals throughout the course of the neoadjuvant/adjuvant systemic therapy, and particularly in between scheduled clinic visits (per standard of care dependent on chemotherapy protocol). Specifically, the portal will incorporate the following PROs: the Edmonton Symptom Assessment Scale revised version (ESASr), the European Organization for Research and Treatment of Cancer - Quality of Life Questionnaire Cancer Patients (EORTC-QLQ C30), the European Organization for Research and Treatment of Cancer - Quality of Life Questionnaire Breast Cancer (EORTC-QLQ BR23), and the European Organization for Research and Treatment of Cancer - Quality of Life Questionnaire Colorectal Cancer (EORTC-QLQ CR29), and selected adverse event-related questions related to commonly prescribed neoadjuvant/adjuvant systemic therapy regimens for breast and colorectal cancer. The portal will identify all study participants who have entered scores 4 or greater on the ESASr scale and subsequently alert the participant's research nurse to perform a review of the patient's records and initiate a telephone assessment with the study participant. The study hypothesizes that patients experiencing this level of symptom severity are currently accustomed to initiating contact with the nurse; this is a reactive approach whereby the healthcare team does not respond unless the patient initiates the contact. The investigators propose a more proactive approach whereby the healthcare team initiates the contact as symptoms are reported. By addressing symptoms as they occur, this will most likely reduce the resources (nursing time, etc.) required to address symptoms as a point when they have become more severe or need acute intervention.
For participants with mild symptoms (Less than 4 on ESASr), subjects will be prompted by the online system to refer to standardized patient educational materials on self-management of symptoms (provided as hyperlinks to online web-based standardized self-management information. Hyperlinks to standardized educational materials with instructions on how to manage common symptoms associated with chemotherapy treatment will also be provided to participants on the intervention arm.
For participants who are identified as having a high burden of symptoms (e.g., a score of 4 or greater on any one symptom), the research nurse will be able to pre-emptively offer clinical advice by phone on appropriate symptom management, notify the responsible physician, and provide interventions to alleviate these symptoms as per usual routine. If needed, the research nurse and physician may offer the participant an unscheduled clinic visit to manage symptom crises in person. Conversely, for participants with a very low symptom burden (e.g., all symptom scores less than 4) or no symptoms at all, the portal will offer these individuals an opportunity to opt-out of the next scheduled face-to-face clinic visit within 24 hours prior to the scheduled clinic visit. Prior to the opt-out, the research nurse will also perform a review of the patient's records, conduct a telephone assessment with the participant to assess symptom levels, and notify the physician to confirm that cancelling the in-person clinic visit is both safe and clinically reasonable to pursue. It will ultimately be at the discretion of the treating oncologist whether or not participants feel comfortable canceling this visit. Asymptomatic participants will retain the right to keep the scheduled clinic appointment. All ePROs and their trends over time will be made available at each clinic visit to the primary cancer nurse and oncologist(s) both electronically and on the paper chart to further facilitate treatment decision-making and optimize symptom management.
- Conditions
- Colorectal Cancer, Breast Cancer
- Being tested
- Electronic Tumour-Specific Patient-Reported Outcomes (ePRO) questionnaires
- Medical subject headings
- Colorectal Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic Tumour-Specific Patient-Reported Outcomes (ePRO) questionnairesOther
A web-based portal that prompts participants to enter tumour-specific ePROs at regular intervals in between clinic visits
| Study group | Role | What they receive |
|---|---|---|
| Control group | No 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. |
| Intervention | Experimental | 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. Receives: Other: Electronic Tumour-Specific Patient-Reported Outcomes (ePRO) questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the Quality of Life of Cancer Patients Using EORTC-QLQ C30 Questionnaire
Change from baseline EORTC-QLQ C30 scores at the end of the study will be determined using both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.
Measured: within 1 year
Assessment of the Quality of Life of Breast Cancer Patients Using EORTC-QLQ BR23 Questionnaire
Change from baseline EORTC-QLQ BR23 scores at the end of the study will be determined using five multi-item scales to assess body image, sexual functioning, systemic therapy side effects, breast symptoms, and arm symptoms. In addition, single items assess sexual enjoyment, future perspective and being upset by hair loss. All of the scales and single-item measures range in score from 0 to 100. A high score for the functional scales represents a high/healthy level of functioning, whilst a high score for the symptom scales represents a high level of symptomatology or problems.
Measured: within 1 year
Assessment of the Quality of Life of Colorectal Cancer Patients Using EORTC-QLQ CR29 Questionnaire
Change from baseline EORTC-QLQ CR29 scores at the end of the study will be determined using 4 multi-item scales and 19 single-items assessing a range of symptoms and problems common among patients with colorectal cancer. All of the scales and single-item measures range in score from 0 to 100. A high score for the functional scale and functional single-items represents a high level of functioning, whereas a high score for the symptom scales and symptom single-items represents a high level of symptomatology or problems.
Measured: within 1 year
Secondary outcomes (4)
Impacts of Electronic Quality of Life Questionnaires on Health Care Resource Utilization
Differences in the frequency of clinic appointments, Emergency room visits, and hospitalization between control and intervention groups will be determined using t-test for comparison of means and Wilcoxon tests for comparison of medians between the intervention and control groups.
Measured: within 1 year
Health System Cost
The net cost associated with the total number of emergency room visits, triage center calls, and hospitalization will be compared between the intervention and control groups.
Measured: within 1 year
Rate of Patient satisfaction
Patient satisfaction with their care will be assessed by scoring a satisfaction questionnaire at the end of the study using a 5 level scoring system.
Measured: within 1 year
Patient self-efficacy
Change from baseline self-efficacy scores at the end of the study will be determined using the Cancer Behavior Inventory- Brief (CBI-B) scoring system which rates 12 questions on a scale of 1 to 9. The CBI-B is intended to be a single score measure of coping self-efficacy. The sum of the 12 items is the final score. Higher scores indicate greater coping efficacy.
Measured: within 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2021
- Study start30 Mar 2022
- Primary completion25 Sep 2025
- Study completion25 Sep 2025
Why it stopped: Slow study accrual. Study sponsor decided to terminate the study in consultation with the DSMB.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- AHS Cancer Control Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Tom Baker Cancer Centre
- Responsible party
- Sponsor
- Investigators
- Nancy A Nixon, M.D., Principal investigator, Arthur J.E. Child Comprehensive Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04990895
- Sponsor's protocol ID
- IIT-ePRO
- Status last verified
- Feb 2026
- First submitted
- 28 Jun 2021
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial of Electronic Tumour-Specific Patient-Reported Outcomes in Early-Stage Breast and Colorectal Cancer Patients Undergoing Neoadjuvant/Adjuvant Chemotherapy
- ClinicalTrials.gov ID
- NCT04990895
- Acronym / sponsor ID
- IIT-ePRO
- Conditions
- Colorectal Cancer, Breast Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow study accrual. Study sponsor decided to terminate the study in consultation with the DSMB.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- AHS Cancer Control AlbertaUniversity, hospital or other
- Collaborators
- Tom Baker Cancer Centre
- Study start
- 30 Mar 2022 (actual)
- Primary completion
- 25 Sep 2025 (actual)
- Study completion
- 25 Sep 2025 (actual)
- First posted
- 5 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A single-centre, randomized, 2-arm clinical trial comparing follow-up consisting of tumour-specific Electronic Patient-Reported Outcomes (ePROs) with targeted symptom management versus standard of care follow-up during neoadjuvant/adjuvant systemic therapy
Detailed description
The intervention in this study will consist of a web-based portal that leverages the existing data entry and reporting capacity of the REDCap (Research Electronic Data Capture) platform to prompt study participants to enter various health-related quality of life (HRQOL) and symptom measures online at regular intervals throughout the course of the neoadjuvant/adjuvant systemic therapy, and particularly in between scheduled clinic visits (per standard of care dependent on chemotherapy protocol). Specifically, the portal will incorporate the following PROs: the Edmonton Symptom Assessment Scale revised version (ESASr), the European Organization for Research and Treatment of Cancer - Quality of Life Questionnaire Cancer Patients (EORTC-QLQ C30), the European Organization for Research and Treatment of Cancer - Quality of Life Questionnaire Breast Cancer (EORTC-QLQ BR23), and the European Organization for Research and Treatment of Cancer - Quality of Life Questionnaire Colorectal Cancer (EORTC-QLQ CR29), and selected adverse event-related questions related to commonly prescribed neoadjuvant/adjuvant systemic therapy regimens for breast and colorectal cancer. The portal will identify all study participants who have entered scores 4 or greater on the ESASr scale and subsequently alert the participant's research nurse to perform a review of the patient's records and initiate a telephone assessment with the study participant. The study hypothesizes that patients experiencing this level of symptom severity are currently accustomed to initiating contact with the nurse; this is a reactive approach whereby the healthcare team does not respond unless the patient initiates the contact. The investigators propose a more proactive approach whereby the healthcare team initiates the contact as symptoms are reported. By addressing symptoms as they occur, this will most likely reduce the resources (nursing time, etc.) required to address symptoms as a point when they have become more severe or need acute intervention.
For participants with mild symptoms (Less than 4 on ESASr), subjects will be prompted by the online system to refer to standardized patient educational materials on self-management of symptoms (provided as hyperlinks to online web-based standardized self-management information. Hyperlinks to standardized educational materials with instructions on how to manage common symptoms associated with chemotherapy treatment will also be provided to participants on the intervention arm.
For participants who are identified as having a high burden of symptoms (e.g., a score of 4 or greater on any one symptom), the research nurse will be able to pre-emptively offer clinical advice by phone on appropriate symptom management, notify the responsible physician, and provide interventions to alleviate these symptoms as per usual routine. If needed, the research nurse and physician may offer the participant an unscheduled clinic visit to manage symptom crises in person. Conversely, for participants with a very low symptom burden (e.g., all symptom scores less than 4) or no symptoms at all, the portal will offer these individuals an opportunity to opt-out of the next scheduled face-to-face clinic visit within 24 hours prior to the scheduled clinic visit. Prior to the opt-out, the research nurse will also perform a review of the patient's records, conduct a telephone assessment with the participant to assess symptom levels, and notify the physician to confirm that cancelling the in-person clinic visit is both safe and clinically reasonable to pursue. It will ultimately be at the discretion of the treating oncologist whether or not participants feel comfortable canceling this visit. Asymptomatic participants will retain the right to keep the scheduled clinic appointment. All ePROs and their trends over time will be made available at each clinic visit to the primary cancer nurse and oncologist(s) both electronically and on the paper chart to further facilitate treatment decision-making and optimize symptom management.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No 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. |
| Intervention | Experimental | Other: Electronic Tumour-Specific Patient-Reported Outcomes (ePRO) questionnairesParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participant has provided informed consent prior to initiation of any study specific activities/procedures.
- Men or women ≥18 years old newly diagnosed early stage (stage I, II, or III) breast or colorectal cancer who initiate neoadjuvant/adjuvant systemic therapy after curative intent surgery.
- 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.
Key exclusion criteria (5 listed)
- Lack of fluency or literacy of the English language.
- Lack of access to a computer or internet at home.
- Inability to complete or enter data on the REDCap system.
- Early-stage breast or colorectal cancer patients who are not receiving neoadjuvant/adjuvant chemotherapy (patients undergoing adjuvant hormonal or targeted therapy alone without chemotherapy will be excluded).
- Has known psychiatric or substance abuse disorders that would interfere with compliance with the requirements of the trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electronic Tumour-Specific Patient-Reported Outcomes (ePRO) questionnairesA web-based portal that prompts participants to enter tumour-specific ePROs at regular intervals in between clinic visits | Other | Intervention |
Primary outcome
Assessment of the Quality of Life of Cancer Patients Using EORTC-QLQ C30 Questionnaire
Time frame: within 1 year
Change from baseline EORTC-QLQ C30 scores at the end of the study will be determined using both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.
Assessment of the Quality of Life of Breast Cancer Patients Using EORTC-QLQ BR23 Questionnaire
Time frame: within 1 year
Change from baseline EORTC-QLQ BR23 scores at the end of the study will be determined using five multi-item scales to assess body image, sexual functioning, systemic therapy side effects, breast symptoms, and arm symptoms. In addition, single items assess sexual enjoyment, future perspective and being upset by hair loss. All of the scales and single-item measures range in score from 0 to 100. A high score for the functional scales represents a high/healthy level of functioning, whilst a high score for the symptom scales represents a high level of symptomatology or problems.
Assessment of the Quality of Life of Colorectal Cancer Patients Using EORTC-QLQ CR29 Questionnaire
Time frame: within 1 year
Change from baseline EORTC-QLQ CR29 scores at the end of the study will be determined using 4 multi-item scales and 19 single-items assessing a range of symptoms and problems common among patients with colorectal cancer. All of the scales and single-item measures range in score from 0 to 100. A high score for the functional scale and functional single-items represents a high level of functioning, whereas a high score for the symptom scales and symptom single-items represents a high level of symptomatology or problems.
4 secondary outcomes
Impacts of Electronic Quality of Life Questionnaires on Health Care Resource Utilization
Time frame: within 1 year
Health System Cost
Time frame: within 1 year
Rate of Patient satisfaction
Time frame: within 1 year
Patient self-efficacy
Time frame: within 1 year
Results and safety
The study was stopped early (reason given: Slow study accrual. Study sponsor decided to terminate the study in consultation with the DSMB.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nancy A Nixon, M.D. principal investigator
Arthur J.E. Child Comprehensive Cancer Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electronic Tumour-Specific Patient-Reported Outcomes (ePRO) questionnaires in people with Colorectal Cancer and Breast Cancer, run by AHS Cancer Control Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Slow study accrual. Study sponsor decided to terminate the study in consultation with the DSMB.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the Quality of Life of Cancer Patients Using EORTC-QLQ C30 Questionnaire (time frame: within 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.