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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cancer

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 Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 169610
    • National Cancer Centre Singapore
  • Singapore, Singapore, 465558
    • National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Stage IV cancer patients, their primary informal caregivers and their treating physicians

Description

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:

a) 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in overall quality of life among patients through the last year of life.	We will assess patient's quality of life through FACT-G	From recruitment to death of patient (baseline, 3 month, 6 months, 9 months, 12 months)
Change in anxiety and depression among patients through the last year of life	We will assess patients' anxiety and depression through the Hospital Anxiety and Depression Scale (HADS).	From recruitment to death of patient (baseline, 3 month, 6 months, 9 months, 12 months)
Change in pain severity among patients through the last year of life	We will assess pain reported by patients through visual analog pain scores	From recruitment to death of patient (baseline, 3 month, 6 months, 9 months, 12 months)
Change in activities of daily living among patients through the last year of life	We will assess limitations in activities of daily living of patients through OARS Multidimensional Functional Assessment Questionnaire	From recruitment to death of patient (baseline, 3 month, 6 months, 9 months, 12 months)
Change in patient's perceived quality of care during the last year of life	We will describe patients' assessment of their own care using a scale used by Ayanian et al (JCO, 2010) that consists of 13 questions.	From recruitment to death of patient (baseline, 3 month, 6 months, 9 months, 12 months)
Total health care expenditure during the last year of life through analysis of medical bills	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.	From recruitment to death of patient (baseline, 3 month, 6 months, 9 months, 12 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	From recruitment to death of patient (baseline, 3 month, 6 months, 9 months, 12 months)
Change in caregiver burden through the last year of life	We will assess caregiver burden through modified Caregiver Reaction Assessment Scale Instrument	From recruitment to death of patient (baseline, 3 month, 6 months, 9 months, 12 months)
Change in caregiver's levels of emotional distress through the last year of life	We will assess caregiver's anxiety and depression through the Hospital Anxiety and Depression Scale (HADS).	From recruitment to death of patient (baseline, 3 month, 6 months, 9 months, 12 months)
Caregiver's perception of patient's end-of-life care assessed after patient's death	We will assess caregiver perceived quality of end-of-life care through Caregiver Evaluation of the Quality of End-Of- Life Care( CEQUEL)	8 weeks bereavement
Caregivers bereavement adjustment assessed after patient's death	Post-patient death bereavement adjustment will be assessed through Brief Grief Questionnaire	6 months bereavement

Collaborators and Investigators

• Sponsor: Duke-NUS Graduate Medical School
• Collaborators: National University Hospital, Singapore; National Cancer Centre, Singapore
• Investigators: Principal Investigator: Eric A Finkelstein, PhD, MHA, Duke-NUS Graduate Medical School

Publications and helpful links

General Publications

• Lee J, Shafiq M, Malhotra R, Ozdemir S, Teo I, Malhotra C. Trajectories of Health-related quality of life in patients with Advanced Cancer during the Last Year of Life: findings from the COMPASS study. BMC Palliat Care. 2022 Oct 14;21(1):183. doi: 10.1186/s12904-022-01075-3.
• Malhotra C, Bundoc F, Chaudhry I, Teo I, Ozdemir S, Finkelstein E; COMPASS study group. A prospective cohort study assessing aggressive interventions at the end-of-life among patients with solid metastatic cancer. BMC Palliat Care. 2022 May 16;21(1):73. doi: 10.1186/s12904-022-00970-z.
• Teo I, Singh R, Malhotra C, Ozdemir S, Dent RA, Kumarakulasinghe NB, Yeo WL, Cheung YB, Malhotra R, Kanesvaran R, Yee ACP, Chan N, Wu HY, Chin SM, Allyn HYM, Yang GM, Neo PSH, Nadkarni NV, Harding R, Finkelstein EA. Cost of Medical Care of Patients with Advanced Serious Illness in Singapore (COMPASS): prospective cohort study protocol. BMC Cancer. 2018 Apr 23;18(1):459. doi: 10.1186/s12885-018-4356-z.

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: June 9, 2016
• First Submitted That Met QC Criteria: July 27, 2016
• First Posted (Estimated): August 1, 2016

Study Record Updates

• Last Update Posted (Actual): October 17, 2023
• Last Update Submitted That Met QC Criteria: October 15, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2015/2781

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO