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Trial record 35 of 318 for:    colon cancer | ( Map: Canada )

Living With Colorectal Cancer: Patient and Caregiver Experience

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ClinicalTrials.gov Identifier: NCT03572101
Recruitment Status : Recruiting
First Posted : June 28, 2018
Last Update Posted : October 15, 2019
Sponsor:
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
Information provided by (Responsible Party):
Aynharan Sinnarajah, University of Calgary

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).

Condition or disease
Colorectal Cancer

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.

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Living With Colorectal Cancer: Patient and Caregiver Experience
Actual Study Start Date : January 11, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine


Group/Cohort
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).



Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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. ]
    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).

  2. 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. ]
    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).

  3. 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. ]
    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).

  4. 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. ]
    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).


Other Outcome Measures:
  1. Overall level of support received by patients/caregivers from homecare, cancer centre, long term care, hospital and hospice services at end of life [ Time Frame: 8 weeks post death ]
    A post-bereavement survey (Caregiver Voice) will be used to characterize caregivers' experiences of patient's end of life care



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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).


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03572101


Contacts
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Contact: Aynharan Sinnarajah, MD,MPH,CCFP 1-403-521-3347 ayn.sinnarajah@ahs.ca
Contact: Patricia Biondo, PhD 1-403-210-3953 pbiondo@ucalgary.ca

Locations
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Canada, Alberta
Holy Cross Centre Recruiting
Calgary, Alberta, Canada
Contact: Aynharan Sinnarajah, MD,MPH,CCFP    1-403-521-3347    ayn.sinnarajah@ahs.ca   
Tom Baker Cancer Centre Recruiting
Calgary, Alberta, Canada
Contact: Aynharan Sinnarajah, MD,MPH,CCFP    1-403-521-3347    ayn.sinnarajah@ahs.ca   
Cross Cancer Institute Recruiting
Edmonton, Alberta, Canada
Contact: Sharon Watanabe, MD, FRCPC    1-780-432-8266    Sharon.Watanabe2@ahs.ca   
Sponsors and Collaborators
University of Calgary
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
Investigators
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Principal Investigator: Aynharan Sinnarajah, MD,MPH,CCFP University of Calgary

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Responsible Party: Aynharan Sinnarajah, Assistant Professor, Division of Palliative Medicine, Department of Oncology, University of Calgary
ClinicalTrials.gov Identifier: NCT03572101     History of Changes
Other Study ID Numbers: 201706HRC-387297
First Posted: June 28, 2018    Key Record Dates
Last Update Posted: October 15, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aynharan Sinnarajah, University of Calgary:
colorectal cancer
palliative care
patients
caregivers
quality of life
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases