Colorectal CancerNCT03572101
Living With Colorectal Cancer: Patient and Caregiver Experience
An observational study of Colorectal Cancer, run by University of Calgary at 3 sites in Canada.
Trial summary
This observational study will gather outcome and experience data of patients living with advanced colorectal cancer and their caregivers. The primary objective is to measure how quality of life in this population changes over time (before, during, and after a palliative pathway becomes the new standard of care in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- How many people
- 280 participants
- Where
- 3 sitesCanada
- Study dates
- 11 Jan 2018to 31 Dec 2020
- Phase
- Observational
- 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
Study population: All advanced colorectal cancer patients at the Cross Cancer Institute (Edmonton, Canada), Tom Baker Cancer Centre (Calgary, Canada) and Holy Cross Centre (Calgary) will be screened and invited by their oncology healthcare providers to join the patient outcome and experience data collection. A caregiver, identified by each enrolled patient, may be invited to participate. For the purposes of this study, caregivers are defined as family or friends who provide unpaid assistance with tasks such as transportation and person care. Advanced Colorectal Cancer (aCRC) is defined as primary or metastatic cancer that is unlikely to be cured, controlled, or put into remission with treatment.
Who may be able to join
- All advanced colorectal cancer patients > 18 years of age with one or more of the following:
- Failed first-line chemotherapy (disease progression on imaging); ii) Unable to receive first-line chemotherapy; iii) High symptom need (any score on the Edmonton Symptom Assessment System Revised (ESASr) ≥ 7); iv) Surprise question: In the opinion of a healthcare provider, would not be surprised if the patient died in the next 12 months.
- Caregivers of patients who meet inclusion/exclusion criteria.
Who cannot join
- A participant deemed inappropriate by clinic staff to be approached for an outcomes study for any reason (for example, in crisis).
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Holy Cross Centre
Calgary, Alberta
Tom Baker Cancer Centre
Calgary, Alberta
Cross Cancer Institute
Edmonton, Alberta
About this study
This observational study will gather outcome and experience data of patients living with advanced colorectal cancer and their caregivers. The primary objective is to measure how quality of life in this population changes over time (before, during, and after a palliative pathway becomes the new standard of care in Calgary, Alberta, Canada).
Read the detailed description
- Background and Rationale: Using palliative care early, e.g. concurrent with disease-modifying therapies or from the time of diagnosis of advanced cancer, enhances quality of life for patients and their families and is associated with lower healthcare resource costs at end-of-life. Despite the evidence that early use of palliative care benefits patients and the healthcare system, most patients are referred late in their disease (e.g. <2 months from death). Our health services struggle to systematically provide early and integrated palliative care, to meet the needs of the cancer population. In Calgary, Alberta, typical of other Canadian centres, 60% of patients with metastatic gastrointestinal (GI) cancers have a late (< 3 months from end of life) or no palliative care referral (i.e. no contact with any palliative care service/provider). This lack of timely and early palliative care is associated with aggressive cancer care in 50% of patients, as compared to 25% in those who received earlier palliative care. A Knowledge to Action (KTA) initiative called Palliative Care Early and Systematic (PaCES) has identified gaps in providing early and systematic palliative care to advanced colorectal cancer (aCRC) patients. To address these gaps, a comprehensive care pathway delivering early, systematic palliative care to aCRC patients in Alberta, Canada will be developed as a new standard of care. The pathway will be implemented first in Calgary, Alberta, with Edmonton, Alberta as control site, to allow for testing and refinement before dissemination to Edmonton and across Alberta. As a result of the development of this new care pathway, over the next 3 years changes are anticipated in the delivery of care for aCRC patients.
- Research question and objectives: This observational study will gather outcome and experience data of patients living with advanced colorectal cancer and their caregivers. The primary objective is to measure how quality of life in this population changes over time (before, during, and after a palliative pathway is introduced as the new standard of care in Calgary, Alberta).
- Methods: An observational cohort study with interrupted time series (ITS) data collection will allow us to assess secular trends, determine if there is evidence of serial dependencies in the monthly measures, and to compare measures following system changes in Calgary while observing the same measures over the same time periods in Edmonton. The primary outcome will be how does EQ5D5L (a standardized instrument for use as a measure of health outcome) change over time for patients and caregivers. Questionnaires will be administered to patients monthly for 10 months then every 3 months until the end of the study or death. Questionnaires for the caregiver will be at enrollment, 1 month, then every 3 months until the end of the study.
- Conditions
- Colorectal Cancer
- Keywords
- colorectal cancer, palliative care, patients, caregivers, quality of life
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Calgary Patient Cohort | Patients with advanced colorectal cancer who are recruited from Calgary, Canada before, during, and after an early palliative care pathway becomes the new standard of care in Calgary. | |
| Calgary Caregiver Cohort | Caregivers of patients with advanced colorectal cancer who are recruited from Calgary, Canada before, during, and after an early palliative care pathway becomes the new standard of care in Calgary. | |
| Edmonton Patient Cohort | Patients with advanced colorectal cancer who are recruited from Edmonton, Canada during the same time period (no palliative care pathway introduced). | |
| Edmonton Caregiver Cohort | Caregivers of patients with advanced colorectal cancer who are recruited from Edmonton, Canada during the same time period (no palliative care pathway introduced). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life (EQ-5D-5L scores)
The EQ-5D-5L tool will be used to characterize changes in patients' and caregivers' quality of life scores (index score and individual dimension scores) over time (i.e. as patients near end of life) and between cohorts (i.e. patients/caregivers in Calgary vs. patients/caregivers in Edmonton).
Measured: Patients: at enrollment, then monthly for 10 months, then every 3 months. Caregivers: at enrollment, 1 month, then every 3 months. All until death or end of data collection (31 Dec 2020), whichever came first.
Secondary outcomes (4)
Edmonton Symptom Assessment System-Revised (ESAS-r) symptoms (pain, tiredness, drowsiness, nausea, lack of appetite, depression, anxiety, shortness of breath, and wellbeing)
The ESAS-r measures pain, tiredness, drowsiness, nausea, appetite, shortness of breath, depression, anxiety, and well-being, rated on a 0-10 scale of severity where 0 represents absence of the symptom and 10 represents the worst possible severity. The ESAS-r will be used to characterize the most common patient-reported symptoms, as well as changes in symptom scores (individual symptom scores as well as total score out of 90) over time (i.e. as patients near end of life), and between cohorts (i.e. patients in Calgary vs. patients in Edmonton).
Measured: Patients: at enrollment and then monthly for 10 months, then every 3 months thereafter until death or end of data collection (31Dec2020), whichever came first.
Preparedness for caregiving
The Preparedness for Caregiving Scale is a tool that assesses caregiver readiness for providing care to another person, including preparedness for taking care of physical needs, emotional needs, accessing services, handling the stress of caregiving, making caregiving activities pleasant, handling emergencies, accessing health care system information, and overall preparedness. Items are rated on a 0-4 scale where 0 represents Not at all prepared and 4 represents Very well prepared. The Preparedness for Caregiving Scale will be used to characterize changes in caregivers' preparedness for caregiving (total score out of 32) over time (i.e. as patients near end of life) and between cohorts (i.e. caregivers in Calgary vs. caregivers in Edmonton).
Measured: Caregivers: at enrollment, 1 month, then every 3 months until death of patient or end of data collection (31Dec2020), whichever came first.
Degree of engagement in advance care planning conversations
The "My Conversations" tool is a questionnaire that assesses engagement in advance care planning conversations. The number of advance care planning conversation elements that a patient reports having discussed with a healthcare provider is scored on a 0-4 scale where 0 means no conversation elements and 4 means all conversation elements were discussed. The My Conversations tool will be used to characterize changes in the number of advance care planning conversation elements discussed over time (i.e. as patients near end of life), and between cohorts (i.e. patients in Calgary vs. patients in Edmonton).
Measured: Patients: at enrollment and then monthly for 10 months, then annually until death or end of data collection (31Dec2020), whichever came first.
Patient-reported concerns (emotional, social/family/spiritual, practical, physical, mobility, nutrition, informational, other)
The Canadian Problem Checklist is a checklist of emotional, social/family/spiritual, practical, physical, mobility, nutrition, and informational concerns. The Canadian Problem Checklist will be used to characterize patient concerns over time (i.e. as patients near end of life), and between cohorts (i.e. patients in Calgary vs. patients in Edmonton).
Measured: Patients: at enrollment and then monthly for 10 months, then every 3 months thereafter until death or end of data collection (31Dec2020), whichever came first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2018
- Study start11 Jan 2018
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
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.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alberta, Alberta Health services, Canadian Institutes of Health Research (CIHR), Canadian Partnership Against Cancer, Alberta Cancer Foundation, Cancer Care Ontario, Action Dignity, Government of Alberta
- Responsible party
- Principal investigator, Aynharan Sinnarajah, University of Calgary
- Investigators
- Aynharan Sinnarajah, MD,MPH,CCFP, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03572101
- Sponsor's protocol ID
- 201706HRC-387297
- Status last verified
- Sep 2021
- First submitted
- 11 May 2018
- Last updated
- 30 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- 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 30 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Living With Colorectal Cancer: Patient and Caregiver Experience
- ClinicalTrials.gov ID
- NCT03572101
- Acronym / sponsor ID
- 201706HRC-387297
- Conditions
- Colorectal Cancer
- Keywords
- colorectal cancer, palliative care, patients, caregivers, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- University of Alberta, Alberta Health services, Canadian Institutes of Health Research (CIHR), Canadian Partnership Against Cancer, Alberta Cancer Foundation, Cancer Care Ontario, Action Dignity, Government of Alberta
- Study start
- 11 Jan 2018 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 28 Jun 2018 (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.
This observational study will gather outcome and experience data of patients living with advanced colorectal cancer and their caregivers. The primary objective is to measure how quality of life in this population changes over time (before, during, and after a palliative pathway becomes the new standard of care in Calgary, Alberta, Canada).
Detailed description
- Background and Rationale: Using palliative care early, e.g. concurrent with disease-modifying therapies or from the time of diagnosis of advanced cancer, enhances quality of life for patients and their families and is associated with lower healthcare resource costs at end-of-life. Despite the evidence that early use of palliative care benefits patients and the healthcare system, most patients are referred late in their disease (e.g. <2 months from death). Our health services struggle to systematically provide early and integrated palliative care, to meet the needs of the cancer population. In Calgary, Alberta, typical of other Canadian centres, 60% of patients with metastatic gastrointestinal (GI) cancers have a late (< 3 months from end of life) or no palliative care referral (i.e. no contact with any palliative care service/provider). This lack of timely and early palliative care is associated with aggressive cancer care in 50% of patients, as compared to 25% in those who received earlier palliative care. A Knowledge to Action (KTA) initiative called Palliative Care Early and Systematic (PaCES) has identified gaps in providing early and systematic palliative care to advanced colorectal cancer (aCRC) patients. To address these gaps, a comprehensive care pathway delivering early, systematic palliative care to aCRC patients in Alberta, Canada will be developed as a new standard of care. The pathway will be implemented first in Calgary, Alberta, with Edmonton, Alberta as control site, to allow for testing and refinement before dissemination to Edmonton and across Alberta. As a result of the development of this new care pathway, over the next 3 years changes are anticipated in the delivery of care for aCRC patients.
- Research question and objectives: This observational study will gather outcome and experience data of patients living with advanced colorectal cancer and their caregivers. The primary objective is to measure how quality of life in this population changes over time (before, during, and after a palliative pathway is introduced as the new standard of care in Calgary, Alberta).
- Methods: An observational cohort study with interrupted time series (ITS) data collection will allow us to assess secular trends, determine if there is evidence of serial dependencies in the monthly measures, and to compare measures following system changes in Calgary while observing the same measures over the same time periods in Edmonton. The primary outcome will be how does EQ5D5L (a standardized instrument for use as a measure of health outcome) change over time for patients and caregivers. Questionnaires will be administered to patients monthly for 10 months then every 3 months until the end of the study or death. Questionnaires for the caregiver will be at enrollment, 1 month, then every 3 months until the end of the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Calgary Patient Cohort | – | –Patients with advanced colorectal cancer who are recruited from Calgary, Canada before, during, and after an early palliative care pathway becomes the new standard of care in Calgary. |
| Calgary Caregiver Cohort | – | –Caregivers of patients with advanced colorectal cancer who are recruited from Calgary, Canada before, during, and after an early palliative care pathway becomes the new standard of care in Calgary. |
| Edmonton Patient Cohort | – | –Patients with advanced colorectal cancer who are recruited from Edmonton, Canada during the same time period (no palliative care pathway introduced). |
| Edmonton Caregiver Cohort | – | –Caregivers of patients with advanced colorectal cancer who are recruited from Edmonton, Canada during the same time period (no palliative care pathway introduced). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All advanced colorectal cancer patients at the Cross Cancer Institute (Edmonton, Canada), Tom Baker Cancer Centre (Calgary, Canada) and Holy Cross Centre (Calgary) will be screened and invited by their oncology healthcare providers to join the patient outcome and experience data collection. A caregiver, identified by each enrolled patient, may be invited to participate. For the purposes of this study, caregivers are defined as family or friends who provide unpaid assistance with tasks such as transportation and person care. Advanced Colorectal Cancer (aCRC) is defined as primary or metastatic cancer that is unlikely to be cured, controlled, or put into remission with treatment.
Key inclusion criteria (3 listed)
- All advanced colorectal cancer patients > 18 years of age with one or more of the following:
- Caregivers of patients who meet inclusion/exclusion criteria.
Key exclusion criteria (1 listed)
- A participant deemed inappropriate by clinic staff to be approached for an outcomes study for any reason (for example, in crisis).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Quality of life (EQ-5D-5L scores)
Time frame: Patients: at enrollment, then monthly for 10 months, then every 3 months. Caregivers: at enrollment, 1 month, then every 3 months. All until death or end of data collection (31 Dec 2020), whichever came first.
The EQ-5D-5L tool will be used to characterize changes in patients' and caregivers' quality of life scores (index score and individual dimension scores) over time (i.e. as patients near end of life) and between cohorts (i.e. patients/caregivers in Calgary vs. patients/caregivers in Edmonton).
4 secondary outcomes
Edmonton Symptom Assessment System-Revised (ESAS-r) symptoms (pain, tiredness, drowsiness, nausea, lack of appetite, depression, anxiety, shortness of breath, and wellbeing)
Time frame: Patients: at enrollment and then monthly for 10 months, then every 3 months thereafter until death or end of data collection (31Dec2020), whichever came first.
Preparedness for caregiving
Time frame: Caregivers: at enrollment, 1 month, then every 3 months until death of patient or end of data collection (31Dec2020), whichever came first.
Degree of engagement in advance care planning conversations
Time frame: Patients: at enrollment and then monthly for 10 months, then annually until death or end of data collection (31Dec2020), whichever came first.
Patient-reported concerns (emotional, social/family/spiritual, practical, physical, mobility, nutrition, informational, other)
Time frame: Patients: at enrollment and then monthly for 10 months, then every 3 months thereafter until death or end of data collection (31Dec2020), whichever came first.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2021.
- 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.
Aynharan Sinnarajah, MD,MPH,CCFP principal investigator
University of Calgary
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by University of Calgary at 3 sites 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 30 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Quality of life (EQ-5D-5L scores) (time frame: Patients: at enrollment, then monthly for 10 months, then every 3 months. Caregivers: at enrollment, 1 month, then every 3 months. All until death or end of data collection (31 Dec 2020), whichever came first.). 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 30 Sep 2021.