Care Coach-led Integrated Palliative Surgical Oncology and Rehabilitation Care Model for Advanced Cancer Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Care Coach-led Palliative Surgical Oncology (PSO), Rehabilitation.
- Who it may be relevant to
- Registry conditions: Advanced Cancer. Basic parameters: 21 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Singapore
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Detailed description
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.
Interventions
- Other Care Coach-led Palliative Surgical Oncology (PSO)
* Patients will receive the current standard of care based on their surgeon's usual clinical practice. * Additionally, patients will receive the Care Coach-led Palliative Surgical Oncology (PSO) intervention during all phases of their surgical journey. * After pre-surgery consultations, care coaches will conduct Serious Illness Conversations (SIC) and focus on exploration of patients' hopes and worries, critical functions, social setup, and identification of a healthcare proxy. The SIC will a - Other Rehabilitation
• Patients will receive services from a dedicated rehabilitation service comprising of a Rehabilitation Physician, Physiotherapist, and Dietician. * Pre-surgery: Patients will be triaged based on their frailty \[Clinical Frailty Scale (CFS)\], malnutrition risk \[Malnutrition Universal Screening Tool (MUST)\], and physical function \[5-sit-to-stand (5-STS)\] and will receive preventive rehabilitation interventions tailored to their functional needs. * During surgical admission: The rehabilitati
Primary outcome measures
- HRQoL in patients post-surgery (measured by FACT-G) [Time frame: Baseline, 6 months post-surgery]
Secondary outcome measures (12)
- HRQoL in patients post-surgery (measured by FACT-G) [Time frame: Baseline, 1, 3, 9 and 12 months post-surgery]
- HRQoL in patients post-surgery (measured by EQ-5D-5L) [Time frame: Baseline, 1, 3, 6, 9, 12 months post-surgery]
- Frailty in patients post-surgery [Time frame: Baseline, 1, 3, 6, 9 & 12 months post- surgery]
- Functional lower extremity strength, transitional movements, balance, and fall risk in patients post-surgery [Time frame: Baseline, 1, 3, 6, 9 & 12 months post- surgery]
- Malnutrition and risk for malnutrition in patients post-surgery [Time frame: Baseline, 1, 3, 6, 9 & 12 months post- surgery]
- Patient-surgeon relationship post-surgery [Time frame: Baseline, 1-month post-surgery]
- Documentation of Serious Illness Conversations (SIC) with patients pre-surgery [Time frame: Baseline (i.e pre-surgery)]
- Establishment of Advance Care Planning with patients [Time frame: Within 1-year post-surgery]
- Patients' receipt of specialist palliative care, when complex palliative care needs arise. [Time frame: Within 1-year post- surgery]
- Healthcare utilization of patients [Time frame: Up to 1-year post-surgery]
- Cost of intervention(s) [Time frame: Up to 1-year post-surgery]
- Cost-effectiveness of intervention(s) [Time frame: Up to 1-year post-surgery]
Eligibility criteria
Inclusion criteria
(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.
Exclusion criteria
(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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Singapore · 2 centers
- National Cancer Centre Singapore — Singapore
- Singapore General Hospital — Singapore
Identifiers
NCT: NCT07133269 · PHRGOC24jul-0008