NCT07789093

Brief 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. CONCORD will be delivered by lay healthcare providers. We compare outcomes between participants receiving CONCORD vs usual care.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
26mo left

Started Mar 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress17%
Mar 2026Sep 2028

Study Start

First participant enrolled

March 24, 2026

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 13, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 27, 2026

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2028

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2028

Last Updated

August 27, 2026

Status Verified

August 1, 2026

Enrollment Period

2 years

First QC Date

August 13, 2026

Last Update Submit

August 24, 2026

Conditions

Palliative CareAdvanced Cancer

Keywords

Palliative CareSurgical OncologyOncologyCare coachCoachingDecision makingCancerQuality of LifeCaregiverAdvanced Cancer

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (10)

  • Health-Related Quality of Life (HRQoL) in patients

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

  • Health-Related Quality of Life (HRQoL) in patients

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

  • Decisional Conflict in patients

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

  • Goals of care and life priorities in patients

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

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

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

  • +5 more secondary outcomes

Study Arms (2)

Usual Care

NO INTERVENTION

Participants 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 Intervention

EXPERIMENTAL

Participants 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.

Other: CONCORD coaching intervention

Interventions

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.

CONCORD Coaching Intervention

Eligibility Criteria

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

You may qualify if:

  • (i) 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;
  • (ii) Caregiver
  • 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.

You may not qualify if:

  • (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Singapore General Hospital

Singapore, 169608, Singapore

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

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

    Singapore General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xindi Huang, MSc Psychology

CONTACT

+65 63065636huang.xindi@nccs.com.sg

Louis Shee Siang Lim, Bachelor's degree

CONTACT

+65 63065636lim.shee.sl@sgh.com.sg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 13, 2026

First Posted

August 27, 2026

Study Start

March 24, 2026

Primary Completion (Estimated)

March 30, 2028

Study Completion (Estimated)

September 30, 2028

Last Updated

August 27, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations

SG(1)