Living With Colorectal Cancer: Patient and Caregiver Experience

Colorectal Cancer Clinical Trial

Official title:

Living With Colorectal Cancer: Patient and Caregiver Experience

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03572101
• Other study ID #: 201706HRC-387297
• Status: Completed
• Start date: January 11, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: September 2021
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 Calgary, Alberta, Canada).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Locations

Country	Name	City	State
Canada	Holy Cross Centre	Calgary	Alberta
Canada	Tom Baker Cancer Centre	Calgary	Alberta
Canada	Cross Cancer Institute	Edmonton	Alberta

Sponsors (9)

Lead Sponsor	Collaborator
University of Calgary	Action Dignity, Alberta Cancer Foundation, Alberta Health Services, Canadian Institutes of Health Research (CIHR), Canadian Partnership Against Cancer, Cancer Care Ontario, Government of Alberta, University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Overall level of support received by patients/caregivers from homecare, cancer centre, long term care, hospital and hospice services at end of life	A post-bereavement survey (Caregiver Voice) will be used to characterize caregivers' experiences of patient's end of life care	8 weeks post death
Primary	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).	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	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).	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.
Secondary	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).	Caregivers: at enrollment, 1 month, then every 3 months until death of patient or end of data collection (31Dec2020), whichever came first.
Secondary	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).	Patients: at enrollment and then monthly for 10 months, then annually until death or end of data collection (31Dec2020), whichever came first.
Secondary	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).	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.