Cost and Medical Care of Patients With Advanced Serious Illness in Singapore (COMPASS) Study

Sponsor
Duke-NUS Graduate Medical School (Other)
Overall Status
Unknown status
CT.gov ID
NCT02850640
Collaborator
National Cancer Centre, Singapore (Other), National University Hospital, Singapore (Other)
600
2
79
300
3.8

Study Details

Study Description

Brief Summary

Cost and Medical Care of Patients with Advanced Serious Illness in Singapore (COMPASS),is a cohort study which aims to capture health care utilization, cost, and quality of life indicators of patients with advanced cancer and their primary caregivers.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The study will recruit 600 patients with advanced cancer, their primary informal caregivers and their treating physicians. Eligible patients will be recruited from study-sites in Singapore and will be followed until death. Patients and their consenting primary informal caregivers will be interviewed first at baseline and then every 3 months thereafter until the patient's death. A post-death interview with primary informal caregiver will be conducted at 8th week and 6 months after the patient's death. As the majority of the care during last year of life is provided by hospices, the eligible patients will be followed as they receive treatment and care at various hospices. Treating physicians of the patients will be invited to take part in the study. They will be asked to answer a survey conducted only once during the duration of the study.

    Data on medical expenditures incurred by a patient from diagnosis of advanced cancer until death will be collected. With patient consent, these data will be extracted every 6 months from the time of patient enrolment from relevant databases, including hospitals and hospices.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    600 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Cost and Medical Care of Patients With Advanced Serious Illness in Singapore (COMPASS) Study
    Study Start Date :
    Dec 1, 2015
    Anticipated Primary Completion Date :
    Jul 1, 2022
    Anticipated Study Completion Date :
    Jul 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Change in overall quality of life among patients through the last year of life. [From recruitment to death of patient (baseline, 3 month, 6 months, 9 months, 12 months)]

      We will assess patient's quality of life through FACT-G

    2. Change in anxiety and depression among patients through the last year of life [From recruitment to death of patient (baseline, 3 month, 6 months, 9 months, 12 months)]

      We will assess patients' anxiety and depression through the Hospital Anxiety and Depression Scale (HADS).

    3. Change in pain severity among patients through the last year of life [From recruitment to death of patient (baseline, 3 month, 6 months, 9 months, 12 months)]

      We will assess pain reported by patients through visual analog pain scores

    4. Change in activities of daily living among patients through the last year of life [From recruitment to death of patient (baseline, 3 month, 6 months, 9 months, 12 months)]

      We will assess limitations in activities of daily living of patients through OARS Multidimensional Functional Assessment Questionnaire

    5. Change in patient's perceived quality of care during the last year of life [From recruitment to death of patient (baseline, 3 month, 6 months, 9 months, 12 months)]

      We will describe patients' assessment of their own care using a scale used by Ayanian et al (JCO, 2010) that consists of 13 questions.

    6. Total health care expenditure during the last year of life through analysis of medical bills [From recruitment to death of patient (baseline, 3 month, 6 months, 9 months, 12 months)]

      We will calculate total health care expenditure during the last year of patient's life as the sum total of expenditures incurred at clinics etc.

    Secondary Outcome Measures

    1. Change in patient's awareness of prognosis by asking if the patients believe that their current treatment regimen is likely to cure them of cancer [From recruitment to death of patient (baseline, 3 month, 6 months, 9 months, 12 months)]

      We will assess knowledge of disease by asking the extent to which advanced cancer patients understand the severity of their condition and if the patients believe that a treatment regimen is available that could cure them

    2. Change in caregiver burden through the last year of life [From recruitment to death of patient (baseline, 3 month, 6 months, 9 months, 12 months)]

      We will assess caregiver burden through modified Caregiver Reaction Assessment Scale Instrument

    3. Change in caregiver's levels of emotional distress through the last year of life [From recruitment to death of patient (baseline, 3 month, 6 months, 9 months, 12 months)]

      We will assess caregiver's anxiety and depression through the Hospital Anxiety and Depression Scale (HADS).

    4. Caregiver's perception of patient's end-of-life care assessed after patient's death [8 weeks bereavement]

      We will assess caregiver perceived quality of end-of-life care through Caregiver Evaluation of the Quality of End-Of- Life Care( CEQUEL)

    5. Caregivers bereavement adjustment assessed after patient's death [6 months bereavement]

      Post-patient death bereavement adjustment will be assessed through Brief Grief Questionnaire

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria for patients are:
    1. Age ≥ 21 years old

    2. Singaporean or Singapore Permanent Resident

    3. Diagnosis of advanced/ stage IV solid cancer (for non-breast and non-prostate cancer patients). If it is breast or prostate cancer it should be stage IV with metastases to an organ site.

    4. Graded 0-2 on the Eastern Cooperative Oncology Group Performance Status

    5. Intact cognition (of patients ≥60 years of age) as determined by the Abbreviated Mental Test. If patient fails the cognitive test, he/she continues to be eligible for the study although self-reported data will no longer be collected. The Legal Representative of the patient will be approached for providing consent on behalf of the patient, to allow access to review of patient's medical and billing records

    The exclusion criteria for patients are

    1. Patients who are not Singaporeans or Singapore Permanent Residents

    2. Patients who are graded 3 (confined to bed more than 50% of waking hours) and 4 (completely disabled) on the Eastern Cooperative Oncology Group Performance Status.

    3. Patients who are ≤21 years of age

    The inclusion criteria for primary informal caregivers are:
    1. Age ≥ 21 years old

    2. Main person or one of the main providing care to the patient (e.g. accompanying patient for doctor's visits, helping the patient with day to day activities)

    3. Main person or one of the main ensuring provision of care (e.g. supervision of foreign domestic worker so that the patient is looked after)

    4. Main person or one of the main involved in making decisions regarding treatment the patient receives

    5. Patient they are caring for is enrolled in the study

    The exclusion criteria for primary informal caregivers are:
    1. Foreign domestic workers/ maids will be excluded from this study
    The inclusion criteria for physicians are:
    1. Age ≥ 21 years old

    2. Patients they are treating are enrolled in the study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Cancer Centre Singapore Singapore Singapore 169610
    2 National University Hospital Singapore Singapore 465558

    Sponsors and Collaborators

    • Duke-NUS Graduate Medical School
    • National Cancer Centre, Singapore
    • National University Hospital, Singapore

    Investigators

    • Principal Investigator: Eric A Finkelstein, PhD, MHA, Duke-NUS Graduate Medical School

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eric A. Finkelstein, Professor, Duke-NUS Graduate Medical School
    ClinicalTrials.gov Identifier:
    NCT02850640
    Other Study ID Numbers:
    • 2015/2781
    First Posted:
    Aug 1, 2016
    Last Update Posted:
    Jul 22, 2020
    Last Verified:
    Jul 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No

    Study Results

    No Results Posted as of Jul 22, 2020