NCT02850640

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2015

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 9, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 1, 2016

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

October 17, 2023

Status Verified

October 1, 2023

Enrollment Period

8.6 years

First QC Date

June 9, 2016

Last Update Submit

October 15, 2023

Conditions

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (5)

  • 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)

  • 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)

  • 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)

  • Caregiver's perception of patient's end-of-life care assessed after patient's death

    8 weeks bereavement

  • Caregivers bereavement adjustment assessed after patient's death

    6 months bereavement

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Age ≥ 21 years old
  • Singaporean or Singapore Permanent Resident
  • 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.
  • Graded 0-2 on the Eastern Cooperative Oncology Group Performance Status
  • 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

You may not qualify if:

  • Patients who are not Singaporeans or Singapore Permanent Residents
  • 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.
  • Patients who are ≤21 years of age
  • Age ≥ 21 years old
  • 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)
  • 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)
  • Main person or one of the main involved in making decisions regarding treatment the patient receives
  • Patient they are caring for is enrolled in the study
  • a) Foreign domestic workers/ maids will be excluded from this study
  • Age ≥ 21 years old
  • Patients they are treating are enrolled in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

National Cancer Centre Singapore

Singapore, 169610, Singapore

Location

National University Hospital

Singapore, 465558, Singapore

Location

Related Publications (4)

  • 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.

  • Ozdemir S, Ng S, Chaudhry I, Teo I, Malhotra C, Finkelstein EA; COMPASS Study Group. Caregiver-Reported Roles in Treatment Decision Making in Advanced Cancer and Associated Caregiving Burden and Psychological Distress: A Longitudinal Study. Med Decis Making. 2023 Feb;43(2):191-202. doi: 10.1177/0272989X221125408. Epub 2022 Sep 16.

  • 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.

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Eric A Finkelstein, PhD, MHA

    Duke-NUS Graduate Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 9, 2016

First Posted

August 1, 2016

Study Start

December 1, 2015

Primary Completion

July 1, 2024

Study Completion

July 1, 2024

Last Updated

October 17, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations