CancereIMPAQcNCT06168435
e-IMPAQc Systematic Assessment of Patient Reported Outcomes in Cancer Care
A study testing eIMPAQc in people with Cancer, run by St. Mary's Research Center, Canada at 1 site in Canada.
Trial summary
Purpose: The Electronic Implementation of Patient and Caregiver Reported Outcomes across cancer centres in Quebec project, or e-IMPAQc, was launched in 2017. e-IMPAQc's goal is to actively engage patients, their caregivers, healthcare professionals (HCPs), managers, policy makers, researchers and IT personnel to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- eIMPAQc
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteCanada
- Study dates
- 3 Nov 2020to 31 Dec 2024
- 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
- Receiving cancer care at designated center
Who cannot join
- Unable to speak English or French
- Unable to use email and internet
Trial locations and contacts
1 site in 1 country.
About this study
Official title: e-IMPAQc Implementation and Evaluation of a Mobile Application for the Systematic Assessment of Patient and Caregiver Reported Outcomes in Quebec Across the Cancer Continuum (eIMPAQc)
Purpose: The Electronic Implementation of Patient and Caregiver Reported Outcomes across cancer centres in Quebec project, or e-IMPAQc, was launched in 2017. e-IMPAQc's goal is to actively engage patients, their caregivers, healthcare professionals (HCPs), managers, policy makers, researchers and IT personnel to co-develop, implement, and evaluate an evidence-informed electronic patient-reported outcomes (e-PRO) screening and management program across Quebec.
Methods: e-IMPAQc built on the Improving Patient Experience and Health Outcomes Collaborative (iPEHOC) project, the first initiative in the province to implement e-PRO screening and was rolled out in three phases. e-IMPAQc has five main components: 1) primary and secondary standardized e-PRO questionnaires and algorithm; 2) summary report for clinicians with alert system; 3) summary report for patients, with tailored notifications regarding symptom severity; 4) self-management fact sheets library; and 5) clinical dashboard. Phase 1 included initiating change management and the co-development of the e-PRO algorithm with patients, their caregivers, HCPs, managers, policy makers, researchers and IT personnel (herein collectively referred as stakeholders) across seven cancer centres. The iPEHOC algorithm was used as a starting point given its successful implementation in one of the participating cancer centres for several years. Phase 1 also included feasibility work to establish a caregiver-reported outcomes (CROs) algorithm as well as the identification and configuration of appropriate electronic platforms on which to house e-IMPAQc. In Phase 2 the focus was on preparing for imminent implementation through workflow mapping and putting in place implementation support (e.g., site coordinators). A pilot of e-IMPAQc (excluding CROs) was also undertaken at one of the participating centres. In Phase 3, e-IMPAQc is being sequentially rolled out to as many cancer centres as possible and then evaluated. Qualitative and quantitative methods are used to document the process of implementation, patient and caregiver, and knowledge transfer (KT) outcomes.
- Conditions
- Cancer
- Being tested
- eIMPAQc
- Keywords
- ePRO
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eIMPAQcOther
e-IMPAQc has five main components: 1) primary and secondary standardized e-PRO questionnaires and algorithm; 2) summary report for clinicians with alert system; 3) summary report for patients, with tailored notifications regarding symptom severity; 4) self-management fact sheets library; and 5) clinical dashboard.
| Study group | Role | What they receive |
|---|---|---|
| Pre-implementation | No intervention | Outcomes collected in patient populations prior to roll-out of the eIMPAQc |
| Post-implementation | Experimental | Outcomes collected in patient populations after roll-out of eIMPAQc Receives: Other: eIMPAQc |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom severity
Symptom severity as measured by the population-specific eIMPAQc symptom screening algorithm, including the Edmonton Symptom Assessment System Revised (ESAS-r) screening measures. Severity is measured on a scale of 0-10.
Measured: Baseline, 4 months
Patient perception of communication with health care team
6 item Clinician-patient communication subscale of the Primary Care Assessment Survey (PCAS), provides an overall score
Measured: Baseline, 4 months
Patient activation
13 items Patient Activation Measure provides an overall score
Measured: Baseline, 4 months
Quality of life
The EQ-5D-5L is used to measure health related, quality of life. The scale measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each level is rated on scale that describes the degree of problems in that area.
Measured: Bsaseline,4 months
Emergency room visits
Using hospital administrative data, we will report on the number of individual visits to the emergency room
Measured: In the 18 months following consent
Survival
Incidence of mortality
Measured: In the 18 months following consent
Feasibility of using the eIMPAQc ePRO system in cancer care centres
Feasibility of using the eIMPAQc symptom screening and management program will be measured using the following metrics:
- Rates of consent to use eIMPAQc among eligible patients referred/invited to patriciate
- Rates of administration and completion of the eIMPAQc ePRO screening processes
- Number and timing of withdrawals
- Number of eIMPAQc ePRO screenings that generate an alert and/or clinical action
Metrics will be combined with qualitative data from semi-structured interviews with participants to provide an overall assessment of feasibility
Measured: Throughout the implementation period, over the course of each participants' 4-6 month follow-up period
Acceptability of using the eIMPAQc ePRO system in cancer care centres
Acceptability of the components of the eIMPAQc program will be assessed through a 40 item eIMPAQc acceptability questionnaire
Measured: Throughout the implementation period, over the course of each participants' 4-6 month follow-up period
Satisfaction
Measured using the 8 item Client Satisfaction Questionnaire (CSQ-8)
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2023
- Study start3 Nov 2020
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Mary's Research Center, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sylvie Lambert, St. Mary's Research Center, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06168435
- Sponsor's protocol ID
- SMHC 18-24
- Acronym
- eIMPAQc
- Status last verified
- Dec 2023
- First submitted
- 14 Aug 2023
- Last updated
- 13 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- e-IMPAQc Implementation and Evaluation of a Mobile Application for the Systematic Assessment of Patient and Caregiver Reported Outcomes in Quebec Across the Cancer Continuum (eIMPAQc)
- ClinicalTrials.gov ID
- NCT06168435
- Acronym / sponsor ID
- eIMPAQc / SMHC 18-24
- Conditions
- Cancer
- Keywords
- ePRO
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- St. Mary's Research Center, CanadaUniversity, hospital or other
- Study start
- 3 Nov 2020 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 13 Dec 2023 (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.
Purpose: The Electronic Implementation of Patient and Caregiver Reported Outcomes across cancer centres in Quebec project, or e-IMPAQc, was launched in 2017. e-IMPAQc's goal is to actively engage patients, their caregivers, healthcare professionals (HCPs), managers, policy makers, researchers and IT personnel to co-develop, implement, and evaluate an evidence-informed electronic patient-reported outcomes (e-PRO) screening and management program across Quebec.
Methods: e-IMPAQc built on the Improving Patient Experience and Health Outcomes Collaborative (iPEHOC) project, the first initiative in the province to implement e-PRO screening and was rolled out in three phases. e-IMPAQc has five main components: 1) primary and secondary standardized e-PRO questionnaires and algorithm; 2) summary report for clinicians with alert system; 3) summary report for patients, with tailored notifications regarding symptom severity; 4) self-management fact sheets library; and 5) clinical dashboard. Phase 1 included initiating change management and the co-development of the e-PRO algorithm with patients, their caregivers, HCPs, managers, policy makers, researchers and IT personnel (herein collectively referred as stakeholders) across seven cancer centres. The iPEHOC algorithm was used as a starting point given its successful implementation in one of the participating cancer centres for several years. Phase 1 also included feasibility work to establish a caregiver-reported outcomes (CROs) algorithm as well as the identification and configuration of appropriate electronic platforms on which to house e-IMPAQc. In Phase 2 the focus was on preparing for imminent implementation through workflow mapping and putting in place implementation support (e.g., site coordinators). A pilot of e-IMPAQc (excluding CROs) was also undertaken at one of the participating centres. In Phase 3, e-IMPAQc is being sequentially rolled out to as many cancer centres as possible and then evaluated. Qualitative and quantitative methods are used to document the process of implementation, patient and caregiver, and knowledge transfer (KT) outcomes.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-implementation | No intervention | –Outcomes collected in patient populations prior to roll-out of the eIMPAQc |
| Post-implementation | Experimental | Other: eIMPAQcOutcomes collected in patient populations after roll-out of eIMPAQc |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Receiving cancer care at designated center
Key exclusion criteria (2 listed)
- Unable to speak English or French
- Unable to use email and internet
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 |
|---|---|---|
| eIMPAQce-IMPAQc has five main components: 1) primary and secondary standardized e-PRO questionnaires and algorithm; 2) summary report for clinicians with alert system; 3) summary report for patients, with tailored notifications regarding symptom severity; 4) self-management fact sheets library; and 5) clinical dashboard. | Other | Post-implementation |
Primary outcome
Symptom severity
Time frame: Baseline, 4 months
Symptom severity as measured by the population-specific eIMPAQc symptom screening algorithm, including the Edmonton Symptom Assessment System Revised (ESAS-r) screening measures. Severity is measured on a scale of 0-10.
Patient perception of communication with health care team
Time frame: Baseline, 4 months
6 item Clinician-patient communication subscale of the Primary Care Assessment Survey (PCAS), provides an overall score
Patient activation
Time frame: Baseline, 4 months
13 items Patient Activation Measure provides an overall score
Quality of life
Time frame: Bsaseline,4 months
The EQ-5D-5L is used to measure health related, quality of life. The scale measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each level is rated on scale that describes the degree of problems in that area.
Emergency room visits
Time frame: In the 18 months following consent
Using hospital administrative data, we will report on the number of individual visits to the emergency room
Survival
Time frame: In the 18 months following consent
Incidence of mortality
Feasibility of using the eIMPAQc ePRO system in cancer care centres
Time frame: Throughout the implementation period, over the course of each participants' 4-6 month follow-up period
Feasibility of using the eIMPAQc symptom screening and management program will be measured using the following metrics: * Rates of consent to use eIMPAQc among eligible patients referred/invited to patriciate * Rates of administration and completion of the eIMPAQc ePRO screening processes * Number and timing of withdrawals * Number of eIMPAQc ePRO screenings that generate an alert and/or clinical action Metrics will be combined with qualitative data from semi-structured interviews with participants to provide an overall assessment of feasibility
Acceptability of using the eIMPAQc ePRO system in cancer care centres
Time frame: Throughout the implementation period, over the course of each participants' 4-6 month follow-up period
Acceptability of the components of the eIMPAQc program will be assessed through a 40 item eIMPAQc acceptability questionnaire
Satisfaction
Time frame: 4 months
Measured using the 8 item Client Satisfaction Questionnaire (CSQ-8)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eIMPAQc in people with Cancer, run by St. Mary's Research Center, Canada 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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 13 Dec 2023. 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?
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?
Symptom severity (time frame: Baseline, 4 months). The study lists 9 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 13 Dec 2023.