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NCT Number: NCT07133269

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

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.

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Key information

Conditions

Advanced Cancer

Age range

21 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Cancer Centre Singapore, Singapore

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:

  • Unwilling to participate in the study.

(iii) Healthcare Providers (Qualitative interview only):

  • Unwilling to participate in the Qualitative interview.

Treatment and study plan

Care Coach-led Palliative Surgical Oncology (PSO)

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

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.

Primary outcomes

  1. HRQoL in patients post-surgery (measured by FACT-G)

    Time frame: 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 outcomes

  1. HRQoL in patients post-surgery (measured by FACT-G)

    Time frame: 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

  2. HRQoL in patients post-surgery (measured by EQ-5D-5L)

    Time frame: 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.

  3. Frailty in patients post-surgery

    Time frame: 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.

  4. 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

    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.

  5. Malnutrition and risk for malnutrition in patients post-surgery

    Time frame: 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.

  6. Patient-surgeon relationship post-surgery

    Time frame: 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.

  7. Documentation of Serious Illness Conversations (SIC) with patients pre-surgery

    Time frame: 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.

  8. Establishment of Advance Care Planning with patients

    Time frame: 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.

  9. Patients' receipt of specialist palliative care, when complex palliative care needs arise.

    Time frame: 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.

  10. Healthcare utilization of patients

    Time frame: 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.

  11. Cost of intervention(s)

    Time frame: 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.

  12. Cost-effectiveness of intervention(s)

    Time frame: Up to 1-year post-surgery

    The incremental cost-effectiveness of PSO and PSO+R will be quantified from the health system perspective.

Study contacts

Contact information is provided by the study sponsor or research team.

Perlie Ng

CONTACT

[email protected]

+65 6306 1913

Sponsors and collaborators

Lead sponsor

Singapore General Hospital

Other

Collaborators

  • Duke-NUS Graduate Medical School
  • National Cancer Centre, Singapore

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Aug 21, 2025
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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