NCT07133269

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
770

participants targeted

Target at P75+ for not_applicable

Timeline
22mo left

Started Aug 2025

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress32%
Aug 2025Apr 2028

First Submitted

Initial submission to the registry

August 6, 2025

Completed
14 days until next milestone

Study Start

First participant enrolled

August 20, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 21, 2025

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2028

Last Updated

February 12, 2026

Status Verified

August 1, 2025

Enrollment Period

2.1 years

First QC Date

August 6, 2025

Last Update Submit

February 11, 2026

Conditions

Keywords

Palliative CareAdvancer cancerCancer rehabilitationSurgical OncologyCare coachQuality of Life

Outcome Measures

Primary Outcomes (1)

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

    -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.

    Baseline, 6 months post-surgery

Secondary Outcomes (12)

  • 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

  • +7 more secondary outcomes

Study Arms (3)

Usual Care

NO INTERVENTION

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)

EXPERIMENTAL

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.

Other: Care Coach-led Palliative Surgical Oncology (PSO)

Care Coach-led Palliative Surgical Oncology with Rehabilitation (PSO+R)

EXPERIMENTAL

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).

Other: Care Coach-led Palliative Surgical Oncology (PSO)Other: Rehabilitation

Interventions

• 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.

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. * 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 (PSO)Care Coach-led Palliative Surgical Oncology with Rehabilitation (PSO+R)

Eligibility Criteria

Age21 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • (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.

You may not qualify if:

  • (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

National Cancer Centre Singapore

Singapore, 168583, Singapore

RECRUITING

Singapore General Hospital

Singapore, 169608, Singapore

RECRUITING

MeSH Terms

Interventions

Rehabilitation

Intervention Hierarchy (Ancestors)

AftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Jolene Wong, MBBS, MMed (Surgery), MPH

    Singapore General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2025

First Posted

August 21, 2025

Study Start

August 20, 2025

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

April 1, 2028

Last Updated

February 12, 2026

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations