Effectiveness of A Care Coach-led Integrated Palliative Surgical Oncology and Rehabilitation Care Model in Patients With Advanced Cancer Undergoing Major Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 770
- 试验地点
- 4
- 主要终点
- HRQoL in patients post-surgery (measured by FACT-G)
研究概览
简要总结
Advanced cancer is a life-limiting condition that can negatively impact quality of life and function. Patients often suffer from physical, emotional, social, spiritual, and decision-making issues. As such, most would benefit from basic palliative care (PC) which includes establishing goals of care through serious illness conversations (SIC), managing basic pain and other symptoms and addressing psychosocial needs, among others. Patients with advanced cancer are also at higher risk of functional decline due to receiving multiple concurrent treatments. Yet, among patients with advanced cancer undergoing major surgery, there has been little consideration of PC and functional needs.
The palliative surgical care model is a care model in which PC educated surgical oncology teams deliver basic PC, allowing sustainable PC provision to an increasing number of patients living with advanced cancer. In a local pilot palliative surgical care model, it was found that a care coach-led palliative surgical oncology (PSO) care model significantly increased palliative care delivery, ensuring more consistent and comprehensive support for patients. In addition, cancer rehabilitation delivered by rehabilitation professionals addresses functional impairments during the cancer journey, restoring and/or maintaining function and improving quality of life. It also plays a preventive role before surgery, a restorative role during treatment, and a supportive role during cancer progression.
Therefore, to address longitudinal PC and functional needs, an integrated care coach-led palliative surgical oncology rehabilitation (PSO+R) care model involving PC-trained care coaches, surgical oncology teams, rehabilitation professionals, supported by specialist palliative care (SPC) physicians who will provide PC and cancer rehabilitation throughout the patient's advanced cancer journey, is proposed.
详细描述
Advanced cancer is a life-limiting condition that can negatively impact function, quality of life and exerts an excessive strain on caregivers. In Singapore, up to 60% of cancer patients suffer from advanced (stage 3 or 4) cancer at diagnosis and are recipients of resource-intensive and costly life-prolonging treatments including surgery, chemo-, radiation therapy, among others. In fact, approximately 80% of patients with advanced cancer undergo major surgery at some point of their cancer journey. Given their life-limiting cancer, these patients suffer from physical, emotional, social, spiritual, and decision-making issues that can arise near end-of-life. As such, most would benefit from basic palliative care (PC). This includes establishing goals of care through serious illness conversations (SIC), managing basic pain and other symptoms, and addressing psychosocial needs, among others. As they are often recipients of concurrent intensive multi-modality cancer treatments, patients with advanced cancer are also at higher risk of functional decline, and are ten times more likely to experience morbidity or mortality and have a six-fold increase in risks of 30-day emergency readmissions after major surgery as compared to patients without advanced disease. Yet, among patients with advanced cancer undergoing major surgery, there has been little consideration of PC and functional needs, leading to overall poor quality of life.
Palliative surgical care model is a care model in which PC educated surgical oncology teams deliver basic PC, allowing sustainable PC provision to an increasing number of patients diagnosed and living with advanced cancer. In a local pilot palliative surgical care model, it was found that longitudinal PC (as opposed to during the peri-operative period only) and functional needs during the advanced cancer journey were not well-addressed. Additionally, surgeon-led palliative surgical care was not feasible due to time constraints and competing clinical demands. However, it was found that a care coach-led palliative surgical oncology (PSO) care model significantly increased palliative care delivery, ensuring more consistent and comprehensive support for patients. Cancer rehabilitation delivered by rehabilitation professionals addresses functional impairments during the cancer journey and aims to restore and maintain function and improve quality of life. It plays a preventive role before surgery, restorative during adjuvant treatments, and is supportive during cancer progression.
To address longitudinal PC and functional needs, the investigators propose an integrated care coach-led palliative surgical oncology rehabilitation (PSO+R) care model involving PC-trained care coaches, surgical oncology teams, rehabilitation professionals, supported by specialist palliative care (SPC) physicians who will provide PC and cancer rehabilitation throughout the advanced cancer journey. Care coach-led PSO comprises of care coaches who will screen for PC needs, provide basic PC, and trigger referrals to SPC and surgical team when complex needs arise. The cancer rehabilitation team will screen for functional needs and institute tailored interventions. PSO+R care will be implemented before and up to 1 year after surgery. In contrast, usual care, though surgeons may be trained in PC, they are not supported by care coaches nor cancer rehabilitation or SPC teams. They provide standard peri-operative only care without consideration of the unique needs in advanced cancer. The objective of this proposal is to test the incremental effectiveness of care coach-led PSO+R vs PSO only vs usual care in improving health-related quality of life (HRQoL), functional capacity, and PC delivery and determine the cost-effectiveness of PSO+R over the next most costly intervention, among advanced cancer patients undergoing major surgery. To evaluate its effectiveness, the investigators conduct a 3-arm randomized controlled trial comparing outcomes at 6 months in patients receiving PSO+R vs PSO only vs usual care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(i) Patients:
- •Aged 21 and above,
- •Diagnosis of advanced cancer, i.e. stage 3 or 4 solid organ cancer or diagnosed with cancer that requires complex surgery,
- •Planned for elective major surgery (Table of Surgical Procedures (TOSP) table code 4 or more or surgery involves more than one surgical discipline,
- •Able to speak and read English or Chinese
- •(ii) Caregivers:
- •Age 21 and above,
- •Unpaid family or informal caregiver who takes direct care of the patient's day-to-day and healthcare needs, or ensures provision of care to meet the needs, or who is the decision maker with regard to the patient's needs and healthcare,
- •Able to speak and read English or Chinese.
- •(iii) Healthcare Providers (Qualitative interview only):
- •Age 21 and above,
- •Currently working as a Healthcare professional at SGH or NCCS and involved in this study.
排除标准
- •(i) Patients:
- •Patient refusal,
- •Have complex PC needs requiring specialty palliative care (SPC) intervention before surgery,
- •Active mental illness or severe dementia and certified unfit to make medical decision by a specialist physician,
- •Scheduled for Emergency surgery.
- •(ii) Caregivers:
- •1. Unwilling to participate in the study.
- •(iii) Healthcare Providers (Qualitative interview only):
- •1. Unwilling to participate in the Qualitative interview.
研究组 & 干预措施
Usual Care
Patients will receive the current standard of care based on their surgeon's usual clinical practice. [Note: All surgeons in the Division of Surgery & Surgical Oncology (DSSO)- SGH and NCCS are required to attend a basic palliative care course.]
Care Coach-led Palliative Surgical Oncology (PSO)
Patients will receive the current standard of care based on their surgeon's usual clinical practice and the Care Coach-led Palliative Surgical Oncology (PSO) intervention.
干预措施: Care Coach-led Palliative Surgical Oncology (PSO) (Other)
Care Coach-led Palliative Surgical Oncology with Rehabilitation (PSO+R)
Patients will receive the current standard of care based on their surgeon's usual clinical practice, PSO intervention and services from a dedicated rehabilitation service (PSO+R).
干预措施: Care Coach-led Palliative Surgical Oncology (PSO) (Other)
Care Coach-led Palliative Surgical Oncology with Rehabilitation (PSO+R)
Patients will receive the current standard of care based on their surgeon's usual clinical practice, PSO intervention and services from a dedicated rehabilitation service (PSO+R).
干预措施: Rehabilitation (Other)
结局指标
主要结局
HRQoL in patients post-surgery (measured by FACT-G)
时间窗: Baseline, 6 months post-surgery
-The Functional Assessment of Cancer Therapy - General (FACT-G) is a well-validated HRQoL questionnaire that covers 4 domains - physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items) and functional well-being (7 items). Each item has response choices in a 5-point Likert-type scale, with a maximum value of 4 (being, "Very much") and a minimum value of 0 (being "Not at all"). Higher scores indicate a better quality of life.
次要结局
- HRQoL in patients post-surgery (measured by FACT-G)(Baseline, 1, 3, 9 and 12 months post-surgery)
- HRQoL in patients post-surgery (measured by EQ-5D-5L)(Baseline, 1, 3, 6, 9, 12 months post-surgery)
- Frailty in patients post-surgery(Baseline, 1, 3, 6, 9 & 12 months post- surgery)
- Functional lower extremity strength, transitional movements, balance, and fall risk in patients post-surgery(Baseline, 1, 3, 6, 9 & 12 months post- surgery)
- Malnutrition and risk for malnutrition in patients post-surgery(Baseline, 1, 3, 6, 9 & 12 months post- surgery)
- Patient-surgeon relationship post-surgery(Baseline, 1-month post-surgery)
- Documentation of Serious Illness Conversations (SIC) with patients pre-surgery(Baseline (i.e pre-surgery))
- Establishment of Advance Care Planning with patients(Within 1-year post-surgery)
- Patients' receipt of specialist palliative care, when complex palliative care needs arise.(Within 1-year post- surgery)
- Healthcare utilization of patients(Up to 1-year post-surgery)
- Cost of intervention(s)(Up to 1-year post-surgery)
- Cost-effectiveness of intervention(s)(Up to 1-year post-surgery)