Implementation and evaluation of an ambulatory care pathway for intra-arterial treatment of primary liver cancer: study protocol for a multicentre randomised controlled hybrid type 1 trial (CHOC).
Primary liver cancers, including hepatocellular carcinoma and intrahepatic cholangiocarcinoma, are one of the leading causes of cancer-related mortality. Transarterial chemoembolisation (TACE) and radioembolisation (TARE) are established palliative treatments yet they are traditionally performed during inpatient hospitalisation. Recent technical and organisational advances allow for safe same-day ambulatory procedures. In particular, the extent to which ambulatory intra-arterial therapy aligns with patients' expectations, comfort and quality of life remains poorly documented. The Care pathway for Hepatic intra-arterial Oncology in an ambulatory Context study (CHOC) trial aims to evaluate the implementation and effectiveness from both patient-centred and clinical perspectives of an ambulatory care pathway for intra-arterial treatment of primary liver cancer in a multicentre randomised hybrid type 1 trial.
CHOC is a pragmatic, multicentre, randomised controlled hybrid type 1 trial comparing ambulatory versus conventional inpatient care for patients undergoing TACE or TARE for primary liver cancer. A total of 206 patients (103 per arm) will be randomised 1:1 and followed for 7 months. The primary outcome is the patient's global satisfaction score, measured 3 days post-procedure using the EORTC PATSAT-C33 questionnaire. Secondary outcomes include quality of life, safety, clinical outcomes, cost analysis and an embedded qualitative implementation study assessing acceptability, adoption, feasibility and sustainability across centres. Economic analyses will estimate both per-patient costs and the 5-year budget impact for the French national health insurance.
The study has received ethical approval from the Protection of Persons Committee and adheres to the Declaration of Helsinki, good clinical practice and French regulatory requirements. Findings will be disseminated through peer-reviewed publications, conferences and participating centres to guide broader implementation of ambulatory interventional radiology care.
NCT06990659.
CHOC is a pragmatic, multicentre, randomised controlled hybrid type 1 trial comparing ambulatory versus conventional inpatient care for patients undergoing TACE or TARE for primary liver cancer. A total of 206 patients (103 per arm) will be randomised 1:1 and followed for 7 months. The primary outcome is the patient's global satisfaction score, measured 3 days post-procedure using the EORTC PATSAT-C33 questionnaire. Secondary outcomes include quality of life, safety, clinical outcomes, cost analysis and an embedded qualitative implementation study assessing acceptability, adoption, feasibility and sustainability across centres. Economic analyses will estimate both per-patient costs and the 5-year budget impact for the French national health insurance.
The study has received ethical approval from the Protection of Persons Committee and adheres to the Declaration of Helsinki, good clinical practice and French regulatory requirements. Findings will be disseminated through peer-reviewed publications, conferences and participating centres to guide broader implementation of ambulatory interventional radiology care.
NCT06990659.
Authors
Grégory Grégory, Hammel Hammel, Ronot Ronot, Roux Roux, Barat Barat, Allaire Allaire, Parlati Parlati, Moussa Moussa, Beunon Beunon, Oberti Oberti, Chevallier Chevallier, Anty Anty, Girot Girot, Sutter Sutter, Ganne Ganne, Papadopoulos Papadopoulos, Blanc Blanc, Ghelfi Ghelfi, Decaens Decaens, Yzet Yzet, Nguyen-Khac Nguyen-Khac, Magnin Magnin, Muti Muti, Risson Risson, Tann Tann, Boige Boige, Calame Calame, Richou Richou, Vilgrain Vilgrain, Rautou Rautou, Darsonval Darsonval, Nhora Nhora, Devictor Devictor, Bouattour Bouattour, Cartron Cartron, Aubé Aubé
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