Living With Colorectal Cancer: Patient and Caregiver Experience

NCT03572101 | Completed

• 1 other identifier: 201706HRC-387297
• Study Type: observational
• Target: 280
• Locations: 1 country
• Sites: 3

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).

Conditions

Colorectal Cancer

Keywords

colorectal cancer; palliative care; patients; caregivers; quality of life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Edmonton Symptom Assessment System-Revised (ESAS-r) symptoms (pain, tiredness, drowsiness, nausea, lack of appetite, depression, anxiety, shortness of breath, and wellbeing)

  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

  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

  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)

  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 (1)

• Overall level of support received by patients/caregivers from homecare, cancer centre, long term care, hospital and hospice services at end of life

  8 weeks post death

Study Arms (4)

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Calgary: lead
• University of Alberta: collaborator
• Alberta Health services: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator
• Canadian Partnership Against Cancer: collaborator
• Alberta Cancer Foundation: collaborator
• Cancer Care Ontario: collaborator
• Action Dignity: collaborator
• Government of Alberta: collaborator

Study Sites (3)

Holy Cross Centre

Calgary, Alberta, Canada

Location

Tom Baker Cancer Centre

Calgary, Alberta, Canada

Location

Cross Cancer Institute

Edmonton, Alberta, Canada

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Aynharan Sinnarajah, MD,MPH,CCFP

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Division of Palliative Medicine, Department of Oncology

Study Record Dates

• First Submitted: May 11, 2018
• First Posted: June 28, 2018
• Study Start: January 11, 2018
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: September 30, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)