Care Coach-led Integrated Palliative Surgical Oncology and Rehabilitation Care Model for Advanced Cancer Patients

Not Applicable

Recruiting

• Conditions: Advanced Cancer

• Registration Number: NCT07133269
• Lead Sponsor: Singapore General Hospital

Brief Summary

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.

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-06
• Study Start: 2025-08-20
• Study First Submitted QC: 2025-08-20
• Last Update Submitted: 2025-08-20
• Study First Posted: 2025-08-21
• Last Update Posted: 2025-08-21
• Primary Completion: 2027-10
• Study Completion: 2028-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 750

Inclusion Criteria

(i) Patients:

1. Aged 21 and above,
2. Diagnosis of advanced cancer, i.e. stage 3 or 4 solid organ cancer,
3. Planned for elective major surgery [Table of Surgical Procedures (TOSP) table code 4 or more], or involvement of multidisciplinary team (MDT) (more than 1 surgical team involved),
4. able to complete either the English or Chinese versions of the health-related quality of life (HRQoL) instruments.

(ii) Caregivers:

1. Age 21 and above,
2. 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 was the decision maker with regard to the patient's needs and healthcare,
3. Consent to be interviewed in English or Chinese.

(iii) Surgeons:

1. Age 21 and above,
2. Accredited specialist surgeon by the Singapore Medical Council Accreditation board.

Exclusion Criteria

(i) Patients:

1. Patient refusal,
2. Have complex PC needs requiring specialty palliative care (SPC) intervention before surgery,
3. Active mental illness or severe dementia and certified unfit to make medical decision by a specialist physician,
4. Emergency surgery.

(ii) Caregivers: 1. Unwilling to participate in study.

(iii) Surgeons: 1. Unwilling to participate in study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
HRQoL in patients post-surgery (measured by FACT-G)	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.

Secondary Outcome Measures

Name	Time	Method
HRQoL in patients post-surgery (measured by FACT-G)	Baseline, 1, 3, 9 and 12 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
HRQoL in patients post-surgery (measured by EQ-5D-5L)	Baseline, 1, 3, 6, 9, 12 months post-surgery	The 5-level EuroQol-5 Dimension instrument (EQ-5D-5L) is a HRQoL questionnaire with five domains (mobility, selfcare, usual activities, pain/discomfort, anxiety/depression) and has five levels for each domain. Scores from all five items will be used to derive a single utility score ranging from 0 to 1, with 0 representing the worst possible health to 1 representing perfect health. It also contains a health state component and a visual analog scale.
Frailty in patients post-surgery	Baseline, 1, 3, 6, 9 & 12 months post- surgery	The Clinical Frailty Scale (CFS) is a well-validated scale to screen for frailty. It is a 9-point scale that quantifies the frailty of the individual based on his/her functioning. There is a minimum score of 1 (indicating "Very Fit) and 9 (indicating Terminally Ill). A higher score is indicative of greater frailty.
Functional lower extremity strength, transitional movements, balance, and fall risk in patients post-surgery	Baseline, 1, 3, 6, 9 & 12 months post- surgery	The Five Times Sit-to-Stand (5-STS) test is a test to assess functional lower extremity strength, transitional movements, balance, and fall risk in patients. The patient is asked to sit against the back of a chair. The time taken to change from a seated position to a standing position five times is measured. A time of less than 12 seconds is linked to better functional lower extremity strength, transitional movements, balance, and reduced risk for falls.
Malnutrition and risk for malnutrition in patients post-surgery	Baseline, 1, 3, 6, 9 & 12 months post- surgery	The Malnutrition Universal Screening Tool (MUST) is a tool to assess for malnutrition and the risk for malnutrition. It consists of five steps and assesses one's risk for malnutrition by evaluating one's Body Mass Index (BMI), rate of weight loss and presence of acute disease. A score of 0 indicates low risk of malnutrition, whereas a score of 2 or more indicates a high risk of malnutrition.
Patient-surgeon relationship post-surgery	Baseline, 1-month post-surgery	The Human Connection (THC) scale measures the therapeutic alliance between patients and their physicians. It consists of 16 questions. Each item has response choices in a 4-point Likert-type scale, with a maximum value of 4 and a minimum value of 1. Higher scores indicate a stronger patient-surgeon relationship.
Documentation of Serious Illness Conversations (SIC) with patients pre-surgery	Baseline (i.e pre-surgery)	Serious Illness Conversations (SIC) (adapted from Ariadne Labs) enable Healthcare providers to understand patients' values and goals. This would be used as part of a palliative care delivery quality indicator.
Establishment of Advance Care Planning with patients	Within 1-year post-surgery	Advance Care Planning is a process of discussing one's values and future care preferences. This would be used as part of a palliative care delivery quality indicator.
Patients' receipt of specialist palliative care, when complex palliative care needs arise.	Within 1-year post- surgery	Patients with complex palliative care needs will be referred to specialist palliative care physicians, meeting the needs of patients and promoting HRQoL. This would be used as part of a palliative care delivery quality indicator.
Healthcare utilization of patients	Up to 1-year post-surgery	Healthcare utilization will be determined by extracting the length of index hospitalization, all-cause emergency department visits, and total hospital days up to 1-year post-surgery.
Cost of intervention(s)	Up to 1-year post-surgery	Inpatient and outpatient billing records will be considered in total all-cause healthcare costs up to 1-year post-surgery.
Cost-effectiveness of intervention(s)	Up to 1-year post-surgery	The incremental cost-effectiveness of PSO and PSO+R will be quantified from the health system perspective.

Trial Locations

Locations (2)

National Cancer Centre Singapore; 🇸🇬 Singapore, Singapore

Singapore General Hospital; 🇸🇬 Singapore, Singapore