The goal of this clinical trial is to evaluate the communication and care coordinator (CCC) model in a national cancer institute and assess the utility of the model in facilitating serious illness communication (SIC) and care for patients with cancer. The study aims are: * To assess the effectiveness of the CCC model in improving patient outcomes. * To assess the effectiveness of the CCC model in increasing rates of SIC and advance care planning (ACP) record documentation. * To assess the acceptability of the CCC model to patients and clinicians. * To evaluate the feasibility of implementing a CCC model in oncology care. Researchers will compare results from the CCC intervention arm and usual care arm, to see if the CCC model can help improve patient outcomes and facilitate SIC between patients and clinicians. Patient participants will: * Follow the assignment of their clinician, who will be assigned randomly to either the usual care group or the intervention group. * Be assigned a CCC and receive 6 CCC sessions over the course of 3 months (if assigned to CCC intervention arm). * Complete 3 study assessment visits at baseline, Week 6, and 3 months * Be invited to a one-time interview to share their study experience (optional, if selected and if in CCC intervention arm).
Timely SIC may facilitate earlier preferred plan of care documentation and improve patients' sense of peacefulness, hopefulness, and connectedness with their clinicians. The primary goal of the study is to evaluate the CCC model in a national cancer institute and assess the utility of the model in facilitating SIC and care for patients with cancer through a stepped wedge cluster randomized trial. This approach delivers crucial, empirical insights into how SIC can be efficiently and effectively delivered and potentially allow larger scale implementation and dissemination of the CCC model in Singapore, as an effective model for delivering patient support and facilitating patient-clinician communication in patients with advanced cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Enrollment
560
CCC sessions will be on exploring participant's illness journey thus far, their concerns, values and priorities.
National Cancer Center, Singapore
Singapore, Singapore
Communication Quality
Feeling Heard and Understood Survey (FHU) is a validated 4-item scale that has been used in palliative care to measure effectiveness of the SIC conversations and the value of the therapeutic relationship between the care team and the patient. The lowest possible score is 0 and the highest possible score is 16, with a higher score indicating that the care team listens well, respects patient's needs, and provides clear communication.
Time frame: Baseline, Week 6 after Baseline, and 3 months Post Enrolment.
Quality of Life per FACT-G7
Functional Assessment of Cancer Therapy-General-7 Item version (FACT-G7) is a 7-item questionnaire designed to quickly and effectively capture the most relevant issues to cancer. FACT-G7 scores could potentially range from 0-28, with a higher score indicating a better quality of life.
Time frame: Baseline, Week 6 after Baseline, and 3 months Post Enrolment.
Health Utility
EuroQOL Group 5-Dimension (EQ-5D-5L) contains a 5-item descriptive system measuring 5 dimensions: mobility, self-care, usual activities, pain/ discomfort, anxiety/ depression; a visual analogue scale (VAS) measuring overall health status. EQ-5D Index Value (Utility Score) ranges from 0 to 1.0 with higher value indicating better health-related quality of life. The VAS ranges from 0 to 100, with higher scores reflecting better self-rated health.
Time frame: Baseline, Week 6 after Baseline, and 3 months Post Enrolment.
Spiritual Well-Being
Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being 12 Item Scale (FACIT-Sp-12) is a validated 12-item survey that is commonly used in the palliative care setting. It has 3 subscales (meaning, peace and faith). Scores in each subscale can potentially range from 0-16 and the total scores can range from 0-48. A higher score indicates greater spiritual well-being, better ability to find purpose in life and drawing comfort from spiritual resources.
Time frame: Baseline, Week 6 after Baseline, and 3 months Post Enrolment.
Healthcare Utilization - Rate of Unplanned Acute Hospital Utilization
The rate of unplanned acute hospital utilization through the emergency department during the study will be collected.
Time frame: From Study Enrolment to 3 months Post Enrolment.
Healthcare utilization - Length of hospital stay
Data on the length of stay in hospital (bed days) will be collected.
Time frame: From Study Enrolment until Date of Death, up to 3 years.
Healthcare utilization - Hospital Bill
Data on hospital bill size will be collected.
Time frame: From Study Enrolment until Date of Death, up to 3 years.
Healthcare utilization - Chemotherapy usage (type)
Data on the type of chemotherapy used will be collected.
Time frame: From Study Enrolment until Date of Death, up to 3 years.
Healthcare utilization - Chemotherapy usage (line)
Data on the line of chemotherapy (first, second or third or subsequent (fourth and onwards)) will be collected.
Time frame: From Study Enrolment until Date of Death, up to 3 years.
Healthcare utilization - Intensive care unit visit
Data on the number of intensive care unit visits will be collected.
Time frame: From Study Enrolment until Date of Death, up to 3 years.
Healthcare utilization - Length of intensive care unit visit
Data on the length of intensive care unit visits will be collected.
Time frame: From Study Enrolment until Date of Death, up to 3 years.
Healthcare utilization - Location of death
Data on the location of death will be collected.
Time frame: From Study Enrolment until Date of Death, up to 3 years.
Acceptability - Satisfaction
Client satisfaction survey is a 4-item, 4-point scale survey in which patients provide ratings on their satisfaction with the intervention, and their views on its relevance, timeliness, and impact. It has been validated in research studies in the outpatient setting around mental health support. Score can range from 4-16, with a higher score indicating greater client satisfaction.
Time frame: 3 months Post Enrolment.
Feasibility - Approach-to-Enrolment Rates
Approach-to-enrolment rates - where feasibility is defined that at least 60% of those patients approached could be enrolled into the study.
Time frame: From Commencement of Study Recruitment till the End of Recruitment, up to 24 months.
Feasibility - Patient Retention Rate
Patient retention rate - where feasibility is defined that at least 80% of enrolled patients will be able to participate in the study for the planned study duration (3 months).
Time frame: Baseline through Study Completion, estimated as up to 3 years.
Effectiveness - SIC and ACP documentation
The number of SIC and ACP documentation per clinician per enrolled patient during the study duration will be tracked during the intervention period(s) and during the control period(s). Clinical notes will also be read to evaluate if there was relevant documentation by clinician on SIC related issues.
Time frame: From Commencement of Study Enrollment through Study Completion, estimated as up to 3 years
Effectiveness - Time spent
Time spent by CCC in this model and estimated time spent by clinicians on SICs will be collected.
Time frame: From Commencement of Study Enrollment through Study Completion, estimated as up to 3 years
Acceptability - Clinician experience
Clinicians will be surveyed using a modified version of the Clinician Experience Survey (CES). The original CES was developed by Ariadne Labs for the purposes of assessing clinicians perceived feasibility and barriers in engaging patients in SIC. The researchers will modify the CES to form a 4-item scale (score range 4-16), with a higher score indicating greater clinicians' satisfaction with the CCC intervention.
Benton PT TAM, MSc
CONTACT
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Time frame: At end of intervention period (28th month).