Effectiveness, Acceptability and Feasibility of a Communication and Care Coordinator (CCC) Model in Facilitating Serious Illness Communication (SIC) and Care in Patients With Cancer

Официальное название

Evaluating the Effectiveness, Acceptability and Feasibility of a Communication and Care Coordinator (CCC) Model in Facilitating Serious Illness Communication (SIC) and Care in Patients With Cancer

Обзор

The goal of this clinical trial is to evaluate the communication and care coordinator (CCC) model in a national cancer institute and assess the utility of the model in facilitating serious illness communication (SIC) and care for patients with cancer. The study aims are: * To assess the effectiveness of the CCC model in improving patient outcomes. * To assess the effectiveness of the CCC model in increasing rates of SIC and advance care planning (ACP) record documentation. * To assess the acceptability of the CCC model to patients and clinicians. * To evaluate the feasibility of implementing a CCC model in oncology care. Researchers will compare results from the CCC intervention arm and usual care arm, to see if the CCC model can help improve patient outcomes and facilitate SIC between patients and clinicians. Patient participants will: * Follow the assignment of their clinician, who will be assigned randomly to either the usual care group or the intervention group. * Be assigned a CCC and receive 6 CCC sessions over the course of 3 months (if assigned to CCC intervention arm). * Complete 3 study assessment visits at baseline, Week 6, and 3 months * Be invited to a one-time interview to share their study experience (optional, if selected and if in CCC intervention arm).

Подробное описание

Timely SIC may facilitate earlier preferred plan of care documentation and improve patients' sense of peacefulness, hopefulness, and connectedness with their clinicians. The primary goal of the study is to evaluate the CCC model in a national cancer institute and assess the utility of the model in facilitating SIC and care for patients with cancer through a stepped wedge cluster randomized trial. This approach delivers crucial, empirical insights into how SIC can be efficiently and effectively delivered and potentially allow larger scale implementation and dissemination of the CCC model in Singapore, as an effective model for delivering patient support and facilitating patient-clinician communication in patients with advanced cancer.

Вмешательства

• Другое CCC Intervention
  CCC sessions will be on exploring participant's illness journey thus far, their concerns, values and priorities.

Первичные конечные точки

• Communication Quality [Срок оценки: Baseline, Week 6 after Baseline, and 3 months Post Enrolment.]
• Quality of Life per FACT-G7 [Срок оценки: Baseline, Week 6 after Baseline, and 3 months Post Enrolment.]
• Health Utility [Срок оценки: Baseline, Week 6 after Baseline, and 3 months Post Enrolment.]
• Spiritual Well-Being [Срок оценки: Baseline, Week 6 after Baseline, and 3 months Post Enrolment.]
• Healthcare Utilization - Rate of Unplanned Acute Hospital Utilization [Срок оценки: From Study Enrolment to 3 months Post Enrolment.]
• Healthcare utilization - Length of hospital stay [Срок оценки: From Study Enrolment until Date of Death, up to 3 years.]
• Healthcare utilization - Hospital Bill [Срок оценки: From Study Enrolment until Date of Death, up to 3 years.]
• Healthcare utilization - Chemotherapy usage (type) [Срок оценки: From Study Enrolment until Date of Death, up to 3 years.]
• Healthcare utilization - Chemotherapy usage (line) [Срок оценки: From Study Enrolment until Date of Death, up to 3 years.]
• Healthcare utilization - Intensive care unit visit [Срок оценки: From Study Enrolment until Date of Death, up to 3 years.]

Вторичные конечные точки (6)

• Acceptability - Satisfaction [Срок оценки: 3 months Post Enrolment.]
• Feasibility - Approach-to-Enrolment Rates [Срок оценки: From Commencement of Study Recruitment till the End of Recruitment, up to 24 months.]
• Feasibility - Patient Retention Rate [Срок оценки: Baseline through Study Completion, estimated as up to 3 years.]
• Effectiveness - SIC and ACP documentation [Срок оценки: From Commencement of Study Enrollment through Study Completion, estimated as up to 3 years]
• Effectiveness - Time spent [Срок оценки: From Commencement of Study Enrollment through Study Completion, estimated as up to 3 years]
• Acceptability - Clinician experience [Срок оценки: At end of intervention period (28th month).]

Критерии участия

Критерии включения

Patient Participants

• Aged 21 and above
• Diagnosed with (a) advanced cancer (stage 3 or 4) or (b) non-advanced cancer, but at high risk of recurrence
• Able to speak English or Chinese, irrespective of race

Clinicians

• Oncologists who are at least of designation of associate consultant and above in NCCS

Критерии исключения

Patient Participants

• Confused/not able to sign informed consent
• Diagnosed with untreated hearing or visual loss or psychiatric illness

Clinicians

• Overseas/not practising in Singapore for a significant amount of time

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Организация здравоохранения

Центры проведения

Сингапур · 1 центр

• National Cancer Center, Singapore — Singapore

Публикации

• Bernacki RE, Block SD; American College of Physicians High Value Care Task Force. Communication about serious illness care goals: a review and synthesis of best practices. JAMA Intern Med. 2014 Dec;174(12):1994-2003. doi: 10.1001/jamainternmed.2014.5271. PMID 25330167
• Nikbakhsh N, Moudi S, Abbasian S, Khafri S. Prevalence of depression and anxiety among cancer patients. Caspian J Intern Med. 2014 Summer;5(3):167-70. PMID 25202445
• Kumar P, Wixon-Genack J, Kavanagh J, Sanders JJ, Paladino J, O'Connor NR. Serious Illness Conversations With Outpatient Oncology Clinicians: Understanding the Patient Experience. JCO Oncol Pract. 2020 Dec;16(12):e1507-e1515. doi: 10.1200/JOP.19.00765. Epub 2020 Aug 4. PMID 32749931
• Geerse OP, Lamas DJ, Sanders JJ, Paladino J, Kavanagh J, Henrich NJ, Berendsen AJ, Hiltermann TJN, Fromme EK, Bernacki RE, Block SD. A Qualitative Study of Serious Illness Conversations in Patients with Advanced Cancer. J Palliat Med. 2019 Jul;22(7):773-781. doi: 10.1089/jpm.2018.0487. Epub 2019 Feb 6. PMID 30724693
• Paladino J, Koritsanszky L, Nisotel L, Neville BA, Miller K, Sanders J, Benjamin E, Fromme E, Block S, Bernacki R. Patient and clinician experience of a serious illness conversation guide in oncology: A descriptive analysis. Cancer Med. 2020 Jul;9(13):4550-4560. doi: 10.1002/cam4.3102. Epub 2020 May 4. PMID 32363775
• Baxter R, Fromme EK, Sandgren A. Patient Identification for Serious Illness Conversations: A Scoping Review. Int J Environ Res Public Health. 2022 Mar 31;19(7):4162. doi: 10.3390/ijerph19074162. PMID 35409844
• Sudore RL, Fried TR. Redefining the "planning" in advance care planning: preparing for end-of-life decision making. Ann Intern Med. 2010 Aug 17;153(4):256-61. doi: 10.7326/0003-4819-153-4-201008170-00008. PMID 20713793
• Agency for integrated care. Advance care planning. Accessed via: aic.sg/Care-Services/Advance-Care-Planning-ACP. Last accessed on February 6th 2026.

Идентификаторы

NCT: NCT07733973 · 2026-1239

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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