Cancer
Conditions
Keywords
Communication and Care Coordinators, Serious Illness Communication, Healthcare Communication, Cancer Care, Oncology
Brief summary
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).
Detailed description
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.
Interventions
OTHERCCC Intervention
CCC sessions will be on exploring participant's illness journey thus far, their concerns, values and priorities.
Sponsors
National Cancer Centre, Singapore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Intervention model description
This study will employ a stepped wedge cluster randomized trial design.
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patient Participants * Aged 21 and above * Diagnosed with (a) advanced cancer (stage 3 or 4) or (b) non-advanced cancer, but at high risk of recurrence * Able to speak English or Chinese, irrespective of race Clinicians * Oncologists who are at least of designation of associate consultant and above in NCCS
Exclusion criteria
Patient Participants * Confused/not able to sign informed consent * Diagnosed with untreated hearing or visual loss or psychiatric illness Clinicians * Overseas/not practising in Singapore for a significant amount of time
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Communication Quality | Baseline, Week 6 after Baseline, and 3 months Post Enrolment. | 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. |
| Quality of Life per FACT-G7 | Baseline, Week 6 after Baseline, and 3 months Post Enrolment. | 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. |
| Health Utility | Baseline, Week 6 after Baseline, and 3 months Post Enrolment. | 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. |
| Spiritual Well-Being | Baseline, Week 6 after Baseline, and 3 months Post Enrolment. | 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. |
| Healthcare Utilization - Rate of Unplanned Acute Hospital Utilization | From Study Enrolment to 3 months Post Enrolment. | The rate of unplanned acute hospital utilization through the emergency department during the study will be collected. |
| Healthcare utilization - Length of hospital stay | From Study Enrolment until Date of Death, up to 3 years. | Data on the length of stay in hospital (bed days) will be collected. |
| Healthcare utilization - Hospital Bill | From Study Enrolment until Date of Death, up to 3 years. | Data on hospital bill size will be collected. |
| Healthcare utilization - Chemotherapy usage (type) | From Study Enrolment until Date of Death, up to 3 years. | Data on the type of chemotherapy used will be collected. |
| Healthcare utilization - Chemotherapy usage (line) | From Study Enrolment until Date of Death, up to 3 years. | Data on the line of chemotherapy (first, second or third or subsequent (fourth and onwards)) will be collected. |
| Healthcare utilization - Intensive care unit visit | From Study Enrolment until Date of Death, up to 3 years. | Data on the number of intensive care unit visits will be collected. |
| Healthcare utilization - Length of intensive care unit visit | From Study Enrolment until Date of Death, up to 3 years. | Data on the length of intensive care unit visits will be collected. |
| Healthcare utilization - Location of death | From Study Enrolment until Date of Death, up to 3 years. | Data on the location of death will be collected. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability - Satisfaction | 3 months Post Enrolment. | 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. |
| Feasibility - Approach-to-Enrolment Rates | From Commencement of Study Recruitment till the End of Recruitment, up to 24 months. | Approach-to-enrolment rates - where feasibility is defined that at least 60% of those patients approached could be enrolled into the study. |
| Feasibility - Patient Retention Rate | Baseline through Study Completion, estimated as up to 3 years. | 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). |
| Effectiveness - SIC and ACP documentation | From Commencement of Study Enrollment through Study Completion, estimated as up to 3 years | 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. |
| Effectiveness - Time spent | From Commencement of Study Enrollment through Study Completion, estimated as up to 3 years | Time spent by CCC in this model and estimated time spent by clinicians on SICs will be collected. |
| Acceptability - Clinician experience | At end of intervention period (28th month). | 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. |
Countries
Singapore
Contacts
CONTACTShirlyn NEO Hui Shan, MD, PhD
CONTACTBenton PT TAM, MSc
STUDY_CHAIRShirlyn NEO Hui Shan, MD, PhD
National Cancer Centre, Singapore
Outcome results
None listed