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Coaching in Palliative Surgical Oncology

24. August 2026 aktualisiert von: Jolene Wong Si Min, Singapore General Hospital

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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

220

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

  • Singapur
      • Singapore, Singapur, 169608
        • Rekrutierung
        • Singapore General Hospital
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Inclusion Criteria:

(i) Patient:

  1. Aged 21 or above;
  2. Diagnosis of advanced cancer, i.e. stage 3 or 4 solid organ
  3. Consulted for palliative surgery or other interventions, i.e. procedures aimed at relieving symptoms and improving quality of life
  4. Able to speak English or Mandarin;

(ii) Caregiver

  1. Aged 21 or above;
  2. 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
  3. Able to speak English or Mandarin.

Exclusion Criteria:

(i). Patient

  1. Patient refusal,
  2. Active mental illness or severe dementia, or being certified unfit to make medical decision by a specialist physician,
  3. Pregnant Women

(ii). Caregiver

  1. Self-reported severe mental illness, dementia, active suicidal ideation, uncorrected hearing loss;
  2. Unable to complete caregiver-reported outcomes.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Unterstützende Pflege
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Kein Eingriff: Usual Care
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.
Experimental: CONCORD Coaching Intervention
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.
Sonstiges: CONCORD coaching intervention
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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Quality of serious illness conversations (SIC) with patients
Zeitfenster: Baseline 1 (pre-coaching), Baseline 2 (post-coaching), 1 month, 3 months, 6 months after Baseline 1 (pre-coaching)
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)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Health-Related Quality of Life (HRQoL) in patients
Zeitfenster: Baseline 1 (pre-coaching), Baseline 2 (post-coaching), 1 month, 3 months, 6 months after Baseline 1 (pre-coaching)
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.
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
Zeitfenster: Baseline 1 (pre-coaching), Baseline 2 (post-coaching), 1 month, 3 months, 6 months after Baseline 1 (pre-coaching)
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.
Baseline 1 (pre-coaching), Baseline 2 (post-coaching), 1 month, 3 months, 6 months after Baseline 1 (pre-coaching)
Decisional Conflict in patients
Zeitfenster: Baseline 1 (pre-coaching), Baseline 2 (post-coaching), 1 month, 3 months, 6 months after Baseline 1 (pre-coaching)
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.
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
Zeitfenster: Baseline 1 (pre-coaching), Baseline 2 (post-coaching), 1 month, 3 months, 6 months after Baseline 1 (pre-coaching)
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.
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
Zeitfenster: Baseline 1 (pre-coaching), Baseline 2 (post-coaching), 1 month, 3 months, 6 months after Baseline 1 (pre-coaching)
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.
Baseline 1 (pre-coaching), Baseline 2 (post-coaching), 1 month, 3 months, 6 months after Baseline 1 (pre-coaching)
Decisional conflict in caregivers
Zeitfenster: Baseline 1 (pre-coaching), Baseline 2 (post-coaching), 1 month, 3 months, 6 months after Baseline 1 (pre-coaching)
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.
Baseline 1 (pre-coaching), Baseline 2 (post-coaching), 1 month, 3 months, 6 months after Baseline 1 (pre-coaching)
Satisfaction with care in caregivers
Zeitfenster: Baseline 1 (pre-coaching), Baseline 2 (post-coaching), 1 month, 3 months, 6 months after Baseline 1 (pre-coaching)
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.
Baseline 1 (pre-coaching), Baseline 2 (post-coaching), 1 month, 3 months, 6 months after Baseline 1 (pre-coaching)
Quality of life in caregivers
Zeitfenster: Baseline 1 (pre-coaching), Baseline 2 (post-coaching), 1 month, 3 months, 6 months after Baseline 1 (pre-coaching)
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.
Baseline 1 (pre-coaching), Baseline 2 (post-coaching), 1 month, 3 months, 6 months after Baseline 1 (pre-coaching)
Healthcare utilization of patients
Zeitfenster: Up to 6 months post Baseline 1 (pre-coaching)
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.
Up to 6 months post Baseline 1 (pre-coaching)
Cost of intervention(s) for patients
Zeitfenster: Up to 6 months post Baseline 1 (pre-coaching)
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.
Up to 6 months post Baseline 1 (pre-coaching)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Singapore General Hospital

Mitarbeiter

Duke-NUS Graduate Medical School

Ermittler

  • Hauptermittler: Jolene Si Min Wong, MBBS, MMed (Surgery), MPH, Singapore General Hospital

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

24. März 2026

Primärer Abschluss (Geschätzt)

30. März 2028

Studienabschluss (Geschätzt)

30. September 2028

Studienanmeldedaten

Zuerst eingereicht

13. August 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

24. August 2026

Zuerst gepostet (Tatsächlich)

27. August 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

27. August 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

24. August 2026

Zuletzt verifiziert

1. August 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • HCSAINV25jan-0004

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Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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