Outpatient Versus Inpatient Care Pathway for Intra-arterial Treatment of Primary Liver Cancer (CHOC)

Proportion of consenting patients and description of refusals

Thematic analysis of individual research interviews with a sample of patients included in both arms of the study.

Number of outpatient courses completed compared with the number of scheduled courses; number of candidate, open and active centers.

Thematic analysis of verbatims collected during focus groups with centers

Characteristics of patients whose inclusion in the protocol was refused by the patient/carer.

Thematic content analysis of verbatims collected during individual research interviews with patients in both arms, in order to understand the patient experience throughout the treatment period, and to identify needs and expectations in terms of post-intervention follow-up in both groups.

Proportion of outpatient treatments planned and then cancelled, reasons for non-implementation, perception of obstacles and facilitators via individual interviews and focus groups with caregivers.

Patient-related factors associated with ambulatory care pathway failure (Indication; Techniques; Tolerance of organization).

thematic analysis of verbatims collected in the focus group, focusing on elements identified by caregivers as having contributed to organizational changes to enable implementation of the ambulatory pathway. Elements perceived as obstacles to change will also be identified and analyzed by theme

thematic analysis of verbatims collected during post-treatment interviews, focusing on elements identified by patients as having contributed to their continued health after returning home. Elements relating to improvements to be made to the ambulatory care pathway will also be recorded and analyzed by theme

Visual analogue scale (VAS) for pain : 0 ('no pain') to 10 ('pain as bad as it could possibly be')

Quality Of Life Questionnaire - Satisfaction with Cancer Care - Core questionnaire (EORTC QLQ-PATSAT-C33) for all and specific complementary outpatient module (OUT-PATSAT7) for the outpatient group.

Items are rated from 1 (bad) to 5 (Excellent)

Medical Outcome Study Short Form 12 (SF-12) A score >50 indicates above-average health-related quality of life

Patient's general condition assessed by clinical status (Eastern Cooperative Oncology Group ECOG) from 0 (Fully active, able to carry on all pre-disease performance without restriction) to 5 (dead)

Complications according to the Common Terminology Criteria for Adverse Events (CTCAE) V5.0.5 Items from 1 (mild) to 5 (death)

Technical success defined by completion of the planned procedure. Tumour response according to mRECIST and LI-RADS TRA 2024 (non-evaluable, non-viable, non-progressor, viable)

Anxiety and depression scale (HADS)

Barcelona Clinic Liver Cancer (BCLC) classification stage, sarcopenia (based on imaging).

1. for transarterial chemoembolization (TACE) : selectivity, number of segments treated, % of chemotherapy injected, additional embolization;
2. for transarterial radioembolization (TARE): number of injection sites;
3. for all: procedure duration, center volume, operator volume, treatment line, combination treatment.

Socioeconomic level

Home-hospital travel time

Comorbidities

Clinical status (ECOG)

Questionnary of quality of life = Medical Outcome Study Short Form 12 (SF-12)

From the community, health insurance and hospital perspective (depending on the type of treatment received)

Annual and cumulative 5-year budgetary impact of changing clinical practices towards outpatient management of patients treated intra-arterially for hepatocellular carcinoma, from a health insurance perspective

unplanned hospital admission after the procedure (including same-day unplanned admission), delayed discharge when same-day discharge criteria are not met, or hospital readmission within the predefined early post-procedural window (72 hours)