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

Cancer Clinical Trial

— COMPASS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02850640
• Other study ID #: 2015/2781
• Status: Active, not recruiting
• Start date: December 2015
• Est. completion date: July 1, 2024

Study information

• Verified date: October 2023
• Source: Duke-NUS Graduate Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 600
• Est. completion date: July 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Locations

Country	Name	City	State
Singapore	National Cancer Centre Singapore	Singapore
Singapore	National University Hospital	Singapore

Sponsors (3)

Lead Sponsor	Collaborator
Duke-NUS Graduate Medical School	National Cancer Centre, Singapore, National University Hospital, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	Caregivers bereavement adjustment assessed after patient's death	Post-patient death bereavement adjustment will be assessed through Brief Grief Questionnaire	6 months bereavement