Clinical trial NCT03572101: Living With Colorectal Cancer: Patient and Caregiver Experience
Official title: Living With Colorectal Cancer: Patient and Caregiver Experience
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Keywords: colorectal cancer
palliative care
patients
caregivers
quality of life
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: University of Alberta
name: Alberta Health services
name: Canadian Institutes of Health Research (CIHR)
name: Canadian Partnership Against Cancer
name: Alberta Cancer Foundation
name: Cancer Care Ontario
name: Action Dignity
name: Government of Alberta
First posted: 2018-06-28
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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 Calgary, Alberta, Canada).

Detailed description: 1. 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.
2. 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).
3. 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.

Eligibility criteria: Inclusion Criteria:

* All advanced colorectal cancer patients \> 18 years of age with one or more of the following:

  i) 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.

Exclusion Criteria:

• A participant deemed inappropriate by clinic staff to be approached for an outcomes study for any reason (for example, in crisis).

Primary outcomes:
measure: Quality of life (EQ-5D-5L scores)
timeFrame: 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:
measure: Edmonton Symptom Assessment System-Revised (ESAS-r) symptoms (pain, tiredness, drowsiness, nausea, lack of appetite, depression, anxiety, shortness of breath, and wellbeing)
timeFrame: 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.
measure: Preparedness for caregiving
timeFrame: Caregivers: at enrollment, 1 month, then every 3 months until death of patient or end of data collection (31Dec2020), whichever came first.
measure: Degree of engagement in advance care planning conversations
timeFrame: Patients: at enrollment and then monthly for 10 months, then annually until death or end of data collection (31Dec2020), whichever came first.
measure: Patient-reported concerns (emotional, social/family/spiritual, practical, physical, mobility, nutrition, informational, other)
timeFrame: 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.
Other outcomes:
measure: Overall level of support received by patients/caregivers from homecare, cancer centre, long term care, hospital and hospice services at end of life
timeFrame: 8 weeks post death
Locations:
city: Calgary
country: Canada
facility: Holy Cross Centre
state: Alberta
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre
state: Alberta
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
Study officials:
affiliation: University of Calgary
name: Aynharan Sinnarajah, MD,MPH,CCFP
role: PRINCIPAL_INVESTIGATOR
References: