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

NCT ID: NCT07133269

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 750 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-20
• Study Completion Date: 2028-04-30

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.

Conditions

Advanced Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Usual Care

Patients will receive the current standard of care based on their surgeon's usual clinical practice. \[Note: All surgeons in the Division of Surgery \& Surgical Oncology (DSSO)- SGH and NCCS are required to attend a basic palliative care course.\]

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Care Coach-led Palliative Surgical Oncology (PSO)

Intervention Type: OTHER

• 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 also be conducted at 1, 3, 6, 9 and 12 months post-surgery.
• The Care coach will also screen for psychological and emotional needs using the Distress Thermometer and Problem List (pre-surgery and at 1, 3, 6, 9 &12 months post-surgery). This will help to identify areas requiring palliative interventions such as symptom management or psychosocial support and for follow-up actions to be taken.
• ACP will also be offered at each timepoint to those who have yet to do so.

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).

Group Type: EXPERIMENTAL

Care Coach-led Palliative Surgical Oncology (PSO)

Intervention Type: OTHER

• 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 also be conducted at 1, 3, 6, 9 and 12 months post-surgery.
• The Care coach will also screen for psychological and emotional needs using the Distress Thermometer and Problem List (pre-surgery and at 1, 3, 6, 9 &12 months post-surgery). This will help to identify areas requiring palliative interventions such as symptom management or psychosocial support and for follow-up actions to be taken.
• ACP will also be offered at each timepoint to those who have yet to do so.

Rehabilitation

Intervention Type: OTHER

• 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 rehabilitation physician will review the progress of patients and refer them to a dietitian if needed. Patients may be followed-up by a rehabilitation physician one-month post-discharge and referred to a physiotherapist if required.
• Post-surgery: Patients will be screened by care coaches for health needs using the EQ-5D-5L at months 3, 6, 9 & 12 post-surgery who will make referrals to a rehabilitation physician, nurse and psychologist, as needed.

Interventions

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 also be conducted at 1, 3, 6, 9 and 12 months post-surgery.
• The Care coach will also screen for psychological and emotional needs using the Distress Thermometer and Problem List (pre-surgery and at 1, 3, 6, 9 &12 months post-surgery). This will help to identify areas requiring palliative interventions such as symptom management or psychosocial support and for follow-up actions to be taken.
• ACP will also be offered at each timepoint to those who have yet to do so.

Intervention Type: 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 rehabilitation physician will review the progress of patients and refer them to a dietitian if needed. Patients may be followed-up by a rehabilitation physician one-month post-discharge and referred to a physiotherapist if required.
• Post-surgery: Patients will be screened by care coaches for health needs using the EQ-5D-5L at months 3, 6, 9 & 12 post-surgery who will make referrals to a rehabilitation physician, nurse and psychologist, as needed.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

(i) Patients:

1. Aged 21 and above,

2. Diagnosis of advanced cancer, i.e. stage 3 or 4 solid organ cancer or diagnosed with cancer that requires complex surgery,

3. Planned for elective major surgery (Table of Surgical Procedures (TOSP) table code 4 or more or surgery involves more than one surgical discipline,

4. Able to speak and read English or Chinese

(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 is the decision maker with regard to the patient's needs and healthcare,

3. Able to speak and read English or Chinese.

(iii) Healthcare Providers (Qualitative interview only):

1. Age 21 and above,

2. Currently working as a Healthcare professional at SGH or NCCS and involved in this study.

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. 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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Centre, Singapore

OTHER

Sponsor Role: collaborator

Duke-NUS Graduate Medical School

OTHER

Sponsor Role: collaborator

Singapore General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jolene Wong, MBBS, MMed (Surgery), MPH

Role: PRINCIPAL_INVESTIGATOR

Singapore General Hospital

Locations

National Cancer Centre Singapore

Singapore, Singapore, Singapore

Site Status: RECRUITING

Singapore General Hospital

Singapore, Singapore, Singapore

Site Status: RECRUITING

Countries

Singapore

Central Contacts

Bairavi Joann

Role: CONTACT

bairavi.joann.dej@nccs.com.sg

+65 63065639

Facility Contacts

Joann Bairavi

Role: primary

bairavi.joann.dej@nccs.com.sg

+65 63065639

Bairavi Joann

Role: primary

bairavi.joann.dej@nccs.com.sg

+65 63065639

Other Identifiers

PHRGOC24jul-0008

Identifier Type: -

Identifier Source: org_study_id