Living With Colorectal Cancer: Patient and Caregiver Experience

NCT ID: NCT03572101

Last Updated: 2021-09-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 280 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-01-11
• Study Completion Date: 2020-12-31

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.

Conditions

Colorectal Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Edmonton Patient Cohort

Patients with advanced colorectal cancer who are recruited from Edmonton, Canada during the same time period (no palliative care pathway introduced).

No interventions assigned to this group

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).

No interventions assigned to this group

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.

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alberta

OTHER

Sponsor Role: collaborator

Alberta Health services

OTHER

Sponsor Role: collaborator

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

Canadian Partnership Against Cancer

UNKNOWN

Sponsor Role: collaborator

Alberta Cancer Foundation

OTHER

Sponsor Role: collaborator

Cancer Care Ontario

OTHER

Sponsor Role: collaborator

Action Dignity

OTHER

Sponsor Role: collaborator

Government of Alberta

OTHER_GOV

Sponsor Role: collaborator

University of Calgary

OTHER

Sponsor Role: lead

Responsible Party

Aynharan Sinnarajah

Assistant Professor, Division of Palliative Medicine, Department of Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aynharan Sinnarajah, MD,MPH,CCFP

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Locations

Holy Cross Centre

Calgary, Alberta, Canada

Tom Baker Cancer Centre

Calgary, Alberta, Canada

Cross Cancer Institute

Edmonton, Alberta, Canada

Countries

Canada

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

201706HRC-387297

Identifier Type: -

Identifier Source: org_study_id