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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 560
- 试验地点
- 1
- 主要终点
- Communication Quality
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Oncologists who are at least of designation of associate consultant and above in NCCS
排除标准
- •Patient Participants
- •Confused/not able to sign informed consent
- •Diagnosed with untreated hearing or visual loss or psychiatric illness
- •Overseas/not practising in Singapore for a significant amount of time
结局指标
主要结局
Communication Quality
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: From Study Enrolment until Date of Death, up to 3 years.
Data on hospital bill size will be collected.
Healthcare utilization - Chemotherapy usage (type)
时间窗: 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)
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: From Study Enrolment until Date of Death, up to 3 years.
Data on the location of death will be collected.
次要结局
- Acceptability - Satisfaction(3 months Post Enrolment.)
- Feasibility - Approach-to-Enrolment Rates(From Commencement of Study Recruitment till the End of Recruitment, up to 24 months.)
- Feasibility - Patient Retention Rate(Baseline through Study Completion, estimated as up to 3 years.)
- Effectiveness - SIC and ACP documentation(From Commencement of Study Enrollment through Study Completion, estimated as up to 3 years)
- Effectiveness - Time spent(From Commencement of Study Enrollment through Study Completion, estimated as up to 3 years)
- Acceptability - Clinician experience(At end of intervention period (28th month).)