Clinical trial · Interventional
Better Communication, Better Care Using SICG Assistant Based on Artificial Intelligence
Improving Care for Cancer Patients by Facilitating Communication With Clinicians Through a Serious Illness Communication Program Using an Assistant Based on Artificial Intelligence.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The project 'Better Communication, Better Care' has as its main objective to evaluate the effectiveness of the implementation of the 'Guide to conversation in serious illness (SICG)' by means of a significant reduction in anxiety and depression index in patients with serious illness and their families. Additionally, it aims to explore the perceived utility of this guide from the perspective of patients, families, and healthcare professionals involved in Palliative Care. Another important objective is to assess the effectiveness of the training program to improve communicative competencies of healthcare professionals in real clinical contexts. Furthermore, the project is structured around a pragmatic randomized clinical trial by clusters, where healthcare professionals will be randomized into intervention and control groups, with patients being the unit of analysis. In parallel, a feasibility and usability study of the mobile application and virtual assistant that will support the implementation of the guide will be conducted, evaluating parameters such as learning facility, satisfaction, efficiency, and errors through validated instruments. Finally, a cost-benefit analysis will be carried out to determine the economic efficiency of the program in terms of resource optimization and improvement in care quality.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer Care Providers | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intervention Group | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Usual Care group
- description
- Usual care. the subject recieve the usual care
- type
- EXPERIMENTAL
- label
- SICG Group
- description
- The SICG Group recieved the intervention of the study. As this is a cluster trial, the intervention operates at two levels. In the case of healthcare professionals, the experimental arm receives training in the use of the SICG for subsequent use with their patients. For patients, the experimental group receives the intervention through healthcare professionals' use of the SICG to explore their wishes and expectations regarding their care.
- interventionNames
- Device: Intervention Group
Primary outcomes (1)
- measure
- Change in patient anxiety and depression
- timeFrame
- Baseline, 1 month, 3 months, and 6 months after SICG conversation (or equivalent index visit in the control arm).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adults aged 18-80 years. * Diagnosis of a serious illness, defined as an illness carrying a high risk of mortality that negatively impacts quality of life or daily functioning, and that typically causes significant emotional distress in caregivers. * Karnofsky Performance Status ≥ 50 or Performance Status ≤ 2 or Palliative Performance Scale ≥ 50. * Spanish as native/fluent language, sufficient to complete the study questionnaires. * Cared for by an HCP enrolled in the study (intervention or control arm). * Able and willing to provide written informed consent. Exclusion Criteria: * Cognitive or perceptual impairment that prevents reliable completion of the study questionnaires. * Inability to communicate in Spanish to the level required by the assessment instruments. * Any condition that, in the investigator's judgment, makes participation unsafe or unfeasible (e.g., clinical instability incompatible with follow-up).
References
Publications (10)
- BACKGROUNDPaladino J, Brannen E, Benotti E, Henrich N, Ritchie C, Sanders J, Lakin JR. Implementing Serious Illness Communication Processes in Primary Care: A Qualitative Study. Am J Hosp Palliat Care. 2021 May;38(5):459-466. doi: 10.1177/1049909120951095. Epub 2020 Aug 14. PMID 32794412
- BACKGROUNDJain N, Bernacki RE. Goals of Care Conversations in Serious Illness: A Practical Guide. Med Clin North Am. 2020 May;104(3):375-389. doi: 10.1016/j.mcna.2019.12.001. PMID 32312404
- BACKGROUNDPaladino 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
- BACKGROUNDPaladino J, Koritsanszky L, Neal BJ, Lakin JR, Kavanagh J, Lipsitz S, Fromme EK, Sanders J, Benjamin E, Block S, Bernacki R. Effect of the Serious Illness Care Program on Health Care Utilization at the End of Life for Patients with Cancer. J Palliat Med. 2020 Oct;23(10):1365-1369. doi: 10.1089/jpm.2019.0437. Epub 2020 Jan 3. PMID 31904304
- BACKGROUNDAndrady AL, Pandey KK, Heikkila AM. Interactive effects of solar UV radiation and climate change on material damage. Photochem Photobiol Sci. 2019 Mar 1;18(3):804-825. doi: 10.1039/c8pp90065e. Epub 2019 Feb 27. PMID 30810563
- BACKGROUNDBernacki 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
- BACKGROUNDBernacki R, Hutchings M, Vick J, Smith G, Paladino J, Lipsitz S, Gawande AA, Block SD. Development of the Serious Illness Care Program: a randomised controlled trial of a palliative care communication intervention. BMJ Open. 2015 Oct 6;5(10):e009032. doi: 10.1136/bmjopen-2015-009032.