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Palliative CareNCT07789093

Coaching in Palliative Surgical Oncology

A study testing CONCORD coaching intervention in people with Palliative Care and Advanced Cancer, run by Singapore General Hospital at 1 site in Singapore.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study aims to evaluate the effectiveness of a serious illness coaching intervention (CONCORD) in improving quality of serious illness conversation (SIC), treatment decision-making, goal-concordant care delivery and quality of life in patients with advanced cancer considered for palliative interventions. Read more about this study

Who is it for?
Ages 21 to 99 years
Conditions the study is for
Palliative Care, Advanced Cancer
What is being tested?
CONCORD coaching intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
220 participants
Where
1 siteSingapore
Study dates
24 Mar 2026to 30 Sep 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient:
  • Aged 21 or above;
  • Diagnosis of advanced cancer, i.e. stage 3 or 4 solid organ
  • Consulted for palliative surgery or other interventions, i.e. procedures aimed at relieving symptoms and improving quality of life
  • Able to speak English or Mandarin;
  • Caregiver
Show all 9Show fewer
  • Aged 21 or above;
  • Self-endorsed or identified by the enrolled patient as an unpaid spouse/partner, relative or friend who knows them well and who provides regular care, who does not have to live in the same dwelling
  • Able to speak English or Mandarin.

Who cannot join

  • (i). Patient
  • Patient refusal,
  • Active mental illness or severe dementia, or being certified unfit to make medical decision by a specialist physician,
  • Pregnant Women
  • (ii). Caregiver
  • Self-reported severe mental illness, dementia, active suicidal ideation, uncorrected hearing loss;
  • Unable to complete caregiver-reported outcomes.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Xindi Huang, MSc Psychology contact

+65 63065636

huang.xindi@nccs.com.sg

Louis Shee Siang Lim, Bachelor's degree contact

+65 63065636

lim.shee.sl@sgh.com.sg

Singapore1 site, 1 recruiting
  • Singapore General Hospital

    Singapore, 169608

    Louis Shee Siang Lim, Bachelor's degree, +65 63065636, lim.shee.sl@sgh.com.sg

    Recruiting

Other trials in Singapore

About this study

Official title: Serious Illness Coaching for Patients With Advanced Cancer Undergoing Palliative Interventions

This study aims to evaluate the effectiveness of a serious illness coaching intervention (CONCORD) in improving quality of serious illness conversation (SIC), treatment decision-making, goal-concordant care delivery and quality of life in patients with advanced cancer considered for palliative interventions. CONCORD will be delivered by lay healthcare providers. We compare outcomes between participants receiving CONCORD vs usual care.

Read the detailed description

Patients with advanced cancer often suffer from tumor-related complications requiring palliative interventions. These interventions are aimed at relieving symptoms or improving quality of life and may include surgery, endoscopy, or other interventional radiology procedures. Decision-making for palliative interventions often require careful consideration of patients' values and treatment preferences. These decisions are also high-stakes given the risks of significant procedural-related morbidity and mortality. Prior studies in high risks surgical cohorts have found that peri-operative communication was often suboptimal, contributed by a lack of clarification of patients' health goals and treatment preferences. Decisional regret following palliative surgery was also common.

Patient-directed coaching has been shown improving disease coping and end-of-life decision making in patients with advanced cancer. However, their role in palliative surgical or other interventional decision-making is unclear. As such, we propose a serious illness coaching intervention to improve readiness and decision-making (CONCORD) for patients with advanced cancer considered for palliative surgery or other interventions. Coaching sessions will be delivered by a trained lay care coach and focus on decision-making and future planning aspects of palliative care before and for up to 6 months after consideration for palliative interventions. CONCORD will be implemented in the context of primary palliative care trained surgeons who are adept in delivering primary palliative care interventions, including the conduct of serious illness conversations (SIC).

In this study, we evaluate the effectiveness and implementational process of CONCORD intervention in patients with advanced cancer considered for palliative interventions. To evaluate effectiveness, we conduct randomized controlled trial (RCT) comparing patient-centric outcomes (quality of SIC, decisional conflict, goal-concordant care delivery, quality of life) before and up to 6 months after enrollment, between those receiving CONCORD vs usual care. We also explore the impact of CONCORD on family caregivers. Usual care will include patients managed by primary palliative care trained surgeons without patient coaching sessions. We embed an implementational process evaluation in our RCT in a hybrid type 1 effectiveness-implementation design, using the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework, to enhance understanding of the proposed program, its interaction with contextual factors, barriers and facilitators, and how these together influence outcomes.

Being tested
CONCORD coaching intervention
Keywords
Palliative Care, Surgical Oncology, Oncology, Care coach, Coaching, Decision making, Cancer, Quality of Life, Caregiver, Advanced Cancer
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CONCORD coaching interventionOther

    The care coach will focus on improving readiness and preparedness for components that will be discussed during serious illness conversations (SICs) - (disease understanding/prognosis, fear/worry, goals of care, treatment expectations, informational preferences, trade-offs, caregiver involvement). The coach will also equip patients with basic tools for treatment decision-making and advanced care planning (ACP). The session will be conducted in-person over 30-to-45 minutes. All coaching content is adapted from the serious illness care program developed by Ariadne Labs. This includes an adapted version of the advanced cancer and surgery question prompt list, elements of the serious illness conversations and the "What Matters to Me" serious illness care program booklet. The SICs are conducted at least 12 hours prior to palliative intervention and findings conveyed to surgical team. Coaching sessions would be focused on decision-making and future planning aspects of palliative care.

Study groups in NCT07789093
Study groupRoleWhat they receive
Usual CareNo interventionParticipants receive care under the primary palliative care surgeons, supported by specialist palliative care teams when needed. Serious illness conversations (SICs - disease understanding/prognosis, fear/worry, goals of care, treatment expectations, informational preferences, trade-offs, caregiver involvement) are conducted as per discretion of the surgical team and part of peri-intervention communication upon referral for consideration of palliative surgery or other interventions. No structured coaching is delivered.
CONCORD Coaching InterventionExperimentalParticipants are actively engaged by a trained lay care coach, where serious illness conversations and their various element will be explored (disease understanding/prognosis, fear/worry, goals of care, treatment expectations, informational preferences, trade-offs, caregiver involvement). Following surgical-team led peri-interventional communication, participants receive dedicated coaching at baseline 1 (pre-coaching), baseline 2 (post-coaching) and 1, 3, 6-months after enrolment.
Receives: Other: CONCORD coaching intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Quality of serious illness conversations (SIC) with patients

    We measured the quality of the SIC conducted based on number of components explored. The seven components explored were disease understanding/prognosis, fear/worry, goals of care, treatment expectations, informational preferences, trade-offs, caregiver involvement. The team will ask questions from Serious Illness Conversations Guide (Ariadne Labs), which enable Healthcare providers to understand patients' values and goals. This would be used as part of a palliative care delivery quality indicator. Team members will share with the caregivers of the patient's goals and palliative care needs when the patient is being coached by the care coach.

    Measured: Baseline 1 (pre-coaching), Baseline 2 (post-coaching), 1 month, 3 months, 6 months after Baseline 1 (pre-coaching)

Secondary outcomes (10)
  1. Health-Related Quality of Life (HRQoL) in patients

    We measured HRQoL in patients with the Functional Assessment of Cancer Therapy - General (FACT-G). 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.

    Measured: Baseline 1 (pre-coaching), Baseline 2 (post-coaching), 1 month, 3 months, 6 months after Baseline 1 (pre-coaching)

  2. Health-Related Quality of Life (HRQoL) in patients

    We also measured HRQoL in patients with the 5-level EuroQol-5 Dimension instrument (EQ-5D-5L). 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.

    Measured: Baseline 1 (pre-coaching), Baseline 2 (post-coaching), 1 month, 3 months, 6 months after Baseline 1 (pre-coaching)

  3. Decisional Conflict in patients

    We measured decisional conflict in patients using the Traditional Decisional Conflict Scale (DCS). DCS is a validated 16-item instrument that measures personal perceptions of uncertainty in choosing among options, the factors contributing to uncertainty, and the quality of the decision made. Items are rated on a 5-point Likert scale (0 = Strongly agree to 4 = Strongly disagree). Scores are summed, divided by 16, and multiplied by 25 to produce a total score ranging from 0 (no decisional conflict) to 100 (extremely high decisional conflict). Lower scores indicate less decisional conflict and better decision support.

    Measured: Baseline 1 (pre-coaching), Baseline 2 (post-coaching), 1 month, 3 months, 6 months after Baseline 1 (pre-coaching)

  4. Goals of care and life priorities in patients

    We determined the goals of care and life priorities in patients by using the Life Priorities Survey (LPS). LPS assesses patients' goals and priorities for their medical care across five domains: prolonging life, curing a disease, establishing a diagnosis, preserving function or independence, and relieving symptoms. This tool identifies patients' primary goals of care and will be used to assess concordance between patient-reported priorities and the treatments and interventions received. Changes in life priorities over the cancer and surgical journey will also be examined.

    Measured: Baseline 1 (pre-coaching), Baseline 2 (post-coaching), 1 month, 3 months, 6 months after Baseline 1 (pre-coaching)

  5. Understanding of the patient's goals and SIC components in caregivers

    We measured the caregiver's understanding of the patient's goals and SIC components by using modified questions based on the Serious Illness Conversations Guide (Ariadne Labs). The outcome measure will be assessed by alignment and concordance with the SIC responses and seven components provided by the caregiver's respective patient. The seven components assessed are disease understanding/prognosis, fear/worry, goals of care, treatment expectations, informational preferences, trade-offs, caregiver involvement.

    Measured: Baseline 1 (pre-coaching), Baseline 2 (post-coaching), 1 month, 3 months, 6 months after Baseline 1 (pre-coaching)

  6. Decisional conflict in caregivers

    We measured decisional conflict in patients using a modified Decisional Conflict Scale (DCS) tailored to the perspective of the caregivers. DCS is a validated 16-item instrument that measures personal perceptions of uncertainty in choosing among options, the factors contributing to uncertainty, and the quality of the decision made. Items are rated on a 5-point Likert scale (0 = Strongly agree to 4 = Strongly disagree). Scores are summed, divided by 16, and multiplied by 25 to produce a total score ranging from 0 (no decisional conflict) to 100 (extremely high decisional conflict). Lower scores indicate less decisional conflict and better decision support.

    Measured: Baseline 1 (pre-coaching), Baseline 2 (post-coaching), 1 month, 3 months, 6 months after Baseline 1 (pre-coaching)

  7. Satisfaction with care in caregivers

    We measured the caregiver satisfaction by using the Family Satisfaction with the End-of-Life Care-2 (FAMCARE-2). FAMCARE-2 is a validated 17-item instrument measuring family caregiver satisfaction with palliative care. It assesses satisfaction across four domains: management of physical symptoms and comfort, provision of information, family support, and patient psychological care. Each item is rated on a 5-point Likert scale (1 = "Very satisfied" to 5 = "Very dissatisfied"). Scores are summed to produce a total score ranging from 17 to 85, with lower scores indicating greater satisfaction with care. The FAMCARE-2 will be used to evaluate caregivers' perceived quality of communication, support, and overall satisfaction with the surgical and palliative care provided throughout the surgical journey.

    Measured: Baseline 1 (pre-coaching), Baseline 2 (post-coaching), 1 month, 3 months, 6 months after Baseline 1 (pre-coaching)

  8. Quality of life in caregivers

    We measured the caregiver quality of life with the Singapore Caregiver Quality of Life Scale (SCQOLS-15). SCQOLS-15 is a validated 15-item instrument developed and normed specifically for caregivers of patients in the Singapore context. It assesses caregiver quality of life across multiple domains capturing the physical, emotional, social, and practical impact of caregiving for a patient with serious illness. The SCQOLS-15 will be used to evaluate the broader impact of the patient's advanced cancer and surgical journey on caregiver well-being, and to assess whether the CONCORD coaching program - through improved communication, goal alignment, and caregiver preparedness - translates into meaningful improvements in caregiver quality of life over the study period.

    Measured: Baseline 1 (pre-coaching), Baseline 2 (post-coaching), 1 month, 3 months, 6 months after Baseline 1 (pre-coaching)

  9. Healthcare utilization of patients

    We determined the healthcare utilization of patients by extracting the length of index hospitalization, all-cause emergency department visits, and total hospital days up to 6 months post-surgery.

    Measured: Up to 6 months post Baseline 1 (pre-coaching)

  10. Cost of intervention(s) for patients

    We determined the cost of intervention(s) by extracting inpatient and outpatient billing records will be considered in total all-cause healthcare costs up to 6 months post-surgery.

    Measured: Up to 6 months post Baseline 1 (pre-coaching)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Aug 2026
  2. Study start24 Mar 2026
  3. Primary completion30 Mar 2028 (estimated)
  4. Study completion30 Sep 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
220 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07789093
Sponsor's protocol ID
HCSAINV25jan-0004
Status last verified
Aug 2026
First submitted
13 Aug 2026
Last updated
27 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing CONCORD coaching intervention in people with Palliative Care and Advanced Cancer, run by Singapore General Hospital at 1 site in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Xindi Huang, MSc Psychology (+65 63065636, huang.xindi@nccs.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality of serious illness conversations (SIC) with patients (time frame: Baseline 1 (pre-coaching), Baseline 2 (post-coaching), 1 month, 3 months, 6 months after Baseline 1 (pre-coaching)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.

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