Effectiveness, Acceptability and Feasibility of a Communication and Care Coordinator (CCC) Model in Facilitating Serious Illness Communication (SIC) and Care in Patients With Cancer

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.

Each participant will be assigned a CCC and receive 6 CCC sessions over the course of 3 months.

Other: CCC Intervention

Each participant will continue to be followed by the oncologist and receive usual care but will not receive CCC intervention.

CCC sessions will be on exploring participant's illness journey thus far, their concerns, values and priorities.

Plazo: 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.

Plazo: 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.

Plazo: 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.

Plazo: 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.

Plazo: 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.

Plazo: From Study Enrolment until Date of Death, up to 3 years.

Data on the length of stay in hospital (bed days) will be collected.

Plazo: From Study Enrolment until Date of Death, up to 3 years.

Data on hospital bill size will be collected.

Plazo: From 3 months prior to study enrolment until 3 months after study enrolment.

Data on the type of oncological treatment used will be collected.

Plazo: 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.

Plazo: From Study Enrolment until Date of Death, up to 3 years.

Data on the number of intensive care unit visits will be collected.

Plazo: From Study Enrolment until Date of Death, up to 3 years.

Data on the length of intensive care unit visits will be collected.

Plazo: From Study Enrolment until Date of Death, up to 3 years.

Data on the number of high dependency unit visits will be collected.

Plazo: From Study Enrolment until Date of Death, up to 3 years.

Data on the length of high dependency unit visits will be collected.

Plazo: From Study Enrolment until Date of Death, up to 3 years.

Data on the location of death will be collected.

Plazo: 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.

Plazo: 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.

Plazo: 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).

Plazo: 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.

Plazo: 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.

Plazo: 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.

Evaluating the Effectiveness, Acceptability and Feasibility of a Communication and Care Coordinator (CCC) Model in Facilitating Serious Illness Communication (SIC) and Care in Patients With Cancer