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Coaching in Palliative Surgical Oncology

2026年8月24日 更新者：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.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

220

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

  • 姓名：Louis Shee Siang Lim, Bachelor's degree
  • 电话号码：+65 63065636
  • 邮箱：lim.shee.sl@sgh.com.sg

学习地点

  • 新加坡
      • Singapore、新加坡、169608
        • 招聘中
        • Singapore General Hospital
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：支持治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
无干预：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.
实验性的：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.
其他：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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Quality of serious illness conversations (SIC) with patients
大体时间：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)

次要结果测量

结果测量
措施说明
大体时间
Health-Related Quality of Life (HRQoL) in patients
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Singapore General Hospital

合作者

Duke-NUS Graduate Medical School

调查人员

  • 首席研究员：Jolene Si Min Wong, MBBS, MMed (Surgery), MPH、Singapore General Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年3月24日

初级完成 (估计的)

2028年3月30日

研究完成 (估计的)

2028年9月30日

研究注册日期

首次提交

2026年8月13日

首先提交符合 QC 标准的

2026年8月24日

首次发布 (实际的)

2026年8月27日

研究记录更新

最后更新发布 (实际的)

2026年8月27日

上次提交的符合 QC 标准的更新

2026年8月24日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • HCSAINV25jan-0004

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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