About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Care Coach-led Palliative Surgical Oncology (PSO)
Other intervention* 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 intervention• 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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
HRQoL in patients post-surgery (measured by EQ-5D-5L)
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
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
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.
Sponsors and contacts
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Singapore General Hospital
Lead sponsor
National Cancer Centre, Singapore
Collaborator
Duke-NUS Graduate Medical School
Collaborator