Clinical trial NCT02850640: Cost and Medical Care of Patients With Advanced Serious Illness in Singapore (COMPASS) Study
Official title: Cost and Medical Care of Patients With Advanced Serious Illness in Singapore (COMPASS) Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cancer
Lead sponsor: Duke-NUS Graduate Medical School
Sponsor class: OTHER
Collaborators: name: National Cancer Centre, Singapore
name: National University Hospital, Singapore
First posted: 2016-08-01
Enrollment: 600
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stage IV cancer patients, their primary informal caregivers and their treating physicians

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in overall quality of life among patients through the last year of life.
timeFrame: From recruitment to death of patient (baseline, 3 month, 6 months, 9 months, 12 months)
measure: Change in anxiety and depression among patients through the last year of life
timeFrame: From recruitment to death of patient (baseline, 3 month, 6 months, 9 months, 12 months)
measure: Change in pain severity among patients through the last year of life
timeFrame: From recruitment to death of patient (baseline, 3 month, 6 months, 9 months, 12 months)
measure: Change in activities of daily living among patients through the last year of life
timeFrame: From recruitment to death of patient (baseline, 3 month, 6 months, 9 months, 12 months)
measure: Change in patient's perceived quality of care during the last year of life
timeFrame: From recruitment to death of patient (baseline, 3 month, 6 months, 9 months, 12 months)
measure: Total health care expenditure during the last year of life through analysis of medical bills
timeFrame: From recruitment to death of patient (baseline, 3 month, 6 months, 9 months, 12 months)
Secondary outcomes:
measure: 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
timeFrame: From recruitment to death of patient (baseline, 3 month, 6 months, 9 months, 12 months)
measure: Change in caregiver burden through the last year of life
timeFrame: From recruitment to death of patient (baseline, 3 month, 6 months, 9 months, 12 months)
measure: Change in caregiver's levels of emotional distress through the last year of life
timeFrame: From recruitment to death of patient (baseline, 3 month, 6 months, 9 months, 12 months)
measure: Caregiver's perception of patient's end-of-life care assessed after patient's death
timeFrame: 8 weeks bereavement
measure: Caregivers bereavement adjustment assessed after patient's death
timeFrame: 6 months bereavement
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National Cancer Centre Singapore
city: Singapore
country: Singapore
facility: National University Hospital
Study officials:
affiliation: Duke-NUS Graduate Medical School
name: Eric A Finkelstein, PhD, MHA
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.