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

University Hospital, Angers206 enrolled

Overview

Randomized multicentre trial comparing two care organisations (ambulatory vs conventional inpatient) for patients undergoing transarterial chemoembolization (TACE) or radioembolization (TARE) for primary liver cancer (Hepato Cellular Carcinoma (HCC) or intrahepatic cholangiocarcinoma (iCCA)). Patients are followed for 7 months to assess patient satisfaction, safety and clinical outcomes. A qualitative implementation study and a medico-economic evaluation (cost analysis and 5-years budget impact analysis) are embedded to assess acceptability, adoption, feasability, and sustainability and to inform scaling.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

206

Conditions

Hepato Cellular Carcinoma (HCC)Intrahepatic Cholangiocarcinoma

Interventions

Patients with Hepato cellular carcinoma (HCC) and Intrahepatic cholangiocarcinoma (iCCA) treated by chemo-embolization (CEH) or radioembolization (REH) are managed on an outpatient basis: hospitalization in an outpatient unit, followed by systematic telephone and on-demand nursing follow-up for 48 hours for REH and 72 hours for CEH. A dedicated re-hospitalization circuit has also been set up in the event of complications.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age ≥ 18 years * HCC or iCCA diagnosed according to the criteria of the European Association for the Study of the Liver (2024) or histologically proven. * HCC or iCCA naive to intra-arterial treatment. HCC or iCCA may have been previously treated with other non-intra-arterial therapies. Other HCC may have been previously treated but not with intra-arterial therapy. * If HCC ou iCCA treatment is proposed at a Multidisciplinary Consultation Meeting (RCP): * Patient Child-Pugh \< B8 * Single or multiple HCC * Absence of lobar or truncal portal obstruction * Absence of bile duct dilatation * If treatment by REH proposed in RCP: * Absence of truncal portal tumor invasion * Uni-lobar tumor invasion (except for centrohepatic iCCA) * Total bilirubin \< 20 mg/l (or 35 µmol/L) * Patient affiliated to or benefiting from a social security scheme * Patient having signed an informed consent form Exclusion Criteria: * Technical contraindication or morphological elements of predictable technical difficulty * Planned combined same day therapeutic strategies at the index procedure (e.g., TACE combined with percutaneous ablation) are not allowed * Chronic renal insufficiency (Clairance \< 30 ml/min) * Known allergy to a contrast agent or chemotherapy agent * inability to participate in ambulatory care (inability to understand and follow discharge instructions, lack of reliable telephone access, absence of a responsible accompanying adult for the first night after discharge, or inability to access urgent care in a timely manner if symptoms occur) * Patient previously included in the study * Patient who, for psychological, social, family or geographical reasons, could not be regularly monitored, patient who, for psychological, social, family or geographical reasons, could not be followed regularly * Concomitant disease or severe uncontrolled clinical situation * Severe uncontrolled infection * Pregnant, breast-feeding or parturient woman * Person deprived of liberty by judicial or administrative decision * Person under compulsory psychiatric care * Person under a legal protection measure * Person unable to give consent

Locations (14)

University hospital of Amiens

Amiens, France

NOT_YET_RECRUITING

University hospital of Angers

Angers, France

RECRUITING

University hospital of Besançon

Besançon, France

RECRUITING

Hospital of Avicennes (AP-HP)

Bobigny, France

NOT_YET_RECRUITING

University hospital of Brest

Brest, France

NOT_YET_RECRUITING

Hospital of Beaujon (AP-HP)

Clichy, France

RECRUITING

Hospital of Vendée

La Roche-sur-Yon, France

RECRUITING

University hospital of Grenoble-Alpes

La Tronche, France

NOT_YET_RECRUITING

University hospital of Montpellier

Montpellier, France

NOT_YET_RECRUITING

University hospital of Nice

Nice, France

RECRUITING

...and 4 more locations

Outcomes

Primary Outcomes

Overall patient satisfaction

EORTC PATSAT-C33 questionnaire. All items are scored 1 (bad) to 5 (excellent). The total score measures range in score from 0 to 100. A high score represents a high level of satisfaction with care / perceived care quality.

Time frame: 72 hours after treatment procedure

Secondary Outcomes

Acceptability (quantitative)

Proportion of consenting patients and description of refusals

Time frame: At inclusion visit (pre-treatment)

Acceptability (qualitative)

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

Time frame: At inclusion visit (pre-treatment)

Adoption (quantitative)

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

Time frame: 32 months

Adoption (qualitative)

Thematic analysis of verbatims collected during focus groups with centers

Time frame: 36 months

Relevance (reasons for refusal)

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

Time frame: 24 months

Relevance (patient expectations)

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.

Time frame: 36 months

Feasibility of outpatient care

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.

Time frame: One year after the end of inclusions

Reach (Quantitative)

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

Time frame: One year after the end of inclusions

Reach (Qualitative for centers)

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

Time frame: One year after the end of inclusions

Reach (Qualitative for patients)

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

Time frame: One year after the end of inclusions

Comparing the organizations (Comfort and satisfaction)

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

Time frame: Day of procedure (baseline), evening after the procedure, and end of the care pathway (up to 72 hours, depending on treatment)

Comparing the organizations (Comfort and satisfaction)

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)

Time frame: 72 hours after procedure

Comparing the organizations (Quality of life)

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

Time frame: At inclusion visit (pre-treatment), Day 7, Month2/Month3 visit

Comparing the organizations (General condition)

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)

Time frame: At inclusion visit (pre-treatment), Month2/Month3 visit

Comparing the organizations (Complications)

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

Time frame: Month 6

Comparing the organizations (Technical succes)

Technical success defined by completion of the planned procedure. Tumor response according to Response Evaluation Criteria in Solid Tumors (mRECIST) and Liver Imaging Reporting and Data System (LIRADS)

Time frame: Month2/Month3 visit, Month 6

Factors for patient satisfaction (HADS)

Anxiety and depression scale (HADS)

Time frame: Inclusion, Admission before surgery and 72 hours after procedure

Factors for patient satisfaction (Disease characteristics)

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

Time frame: At inclusion visit (pre-treatment)

Factors for patient satisfaction (Treatment characteristics)

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

Time frame: Day of treatment procedure

Factors for patient satisfaction (socioeconomic)

Socioeconomic level

Time frame: At inclusion visit (pre-treatment)

Factors for patient satisfaction (travel)

Home-hospital travel time

Time frame: At inclusion visit (pre-treatment)

Factors for patient satisfaction (comorbidities)

Comorbidities

Time frame: At inclusion visit (pre-treatment)

Factors for patient satisfaction (ECOG)

Clinical status (ECOG)

Time frame: At inclusion visit (pre-treatment)

Factors for patient satisfaction (Quality of life)

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

Time frame: At inclusion visit (pre-treatment), Day 7, Month 2/Month3

Total cost of each treatment pathway

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

Time frame: From day of treatment to Month 2/Month 3 visit

Budgetary impact

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

Time frame: 5 years after study

Ambulatory pathway failure

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)

Time frame: within 72 hours post-procedure

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

Overview

Conditions

Interventions

Eligibility

Locations (14)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts