NCT07733973 — Effectiveness, Acceptability and Feasibility of a Communication and Care Coordinator (CCC) Model in Facilitating Serious Illness Communication (SIC) and Care in Patients With Cancer · CancerIndex
Clinical trial · Interventional
Effectiveness, Acceptability and Feasibility of a Communication and Care Coordinator (CCC) Model in Facilitating Serious Illness Communication (SIC) and Care in Patients With Cancer
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
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Each participant will be assigned a CCC and receive 6 CCC sessions over the course of 3 months.
interventionNames
Other: CCC Intervention
type
NO_INTERVENTION
label
Usual Care Arm
description
Each participant will continue to be followed by the oncologist and receive usual care but will not receive CCC intervention.
Primary outcomes (12)
measure
Communication Quality
timeFrame
Baseline, Week 6 after Baseline, and 3 months Post Enrolment.
description
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.
Eligibility
Eligibility (as posted)
Sex
All
Minimum age
21 Years
Show eligibility criteria text
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
References
Publications (37)
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measure
Quality of Life per FACT-G7
timeFrame
Baseline, Week 6 after Baseline, and 3 months Post Enrolment.
description
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.
measure
Health Utility
timeFrame
Baseline, Week 6 after Baseline, and 3 months Post Enrolment.
description
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.
measure
Spiritual Well-Being
timeFrame
Baseline, Week 6 after Baseline, and 3 months Post Enrolment.
description
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.
measure
Healthcare Utilization - Rate of Unplanned Acute Hospital Utilization
timeFrame
From Study Enrolment to 3 months Post Enrolment.
description
The rate of unplanned acute hospital utilization through the emergency department during the study will be collected.
measure
Healthcare utilization - Length of hospital stay
timeFrame
From Study Enrolment until Date of Death, up to 3 years.
description
Data on the length of stay in hospital (bed days) will be collected.
measure
Healthcare utilization - Hospital Bill
timeFrame
From Study Enrolment until Date of Death, up to 3 years.
From Study Enrolment until Date of Death, up to 3 years.
description
Data on the line of chemotherapy (first, second or third or subsequent (fourth and onwards)) will be collected.
measure
Healthcare utilization - Intensive care unit visit
timeFrame
From Study Enrolment until Date of Death, up to 3 years.
description
Data on the number of intensive care unit visits will be collected.
measure
Healthcare utilization - Length of intensive care unit visit
timeFrame
From Study Enrolment until Date of Death, up to 3 years.
description
Data on the length of intensive care unit visits will be collected.
measure
Healthcare utilization - Location of death
timeFrame
From Study Enrolment until Date of Death, up to 3 years.
description
Data on the location of death will be collected.
Secondary outcomes (6)
measure
Acceptability - Satisfaction
timeFrame
3 months Post Enrolment.
description
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.
measure
Feasibility - Approach-to-Enrolment Rates
timeFrame
From Commencement of Study Recruitment till the End of Recruitment, up to 24 months.
description
Approach-to-enrolment rates - where feasibility is defined that at least 60% of those patients approached could be enrolled into the study.
measure
Feasibility - Patient Retention Rate
timeFrame
Baseline through Study Completion, estimated as up to 3 years.
description
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).
measure
Effectiveness - SIC and ACP documentation
timeFrame
From Commencement of Study Enrollment through Study Completion, estimated as up to 3 years
description
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.
measure
Effectiveness - Time spent
timeFrame
From Commencement of Study Enrollment through Study Completion, estimated as up to 3 years
description
Time spent by CCC in this model and estimated time spent by clinicians on SICs will be collected.
measure
Acceptability - Clinician experience
timeFrame
At end of intervention period (28th month).
description
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.
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