Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2024-A02727-40 | Other Identifier | ANSM |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Université Paris Cité | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm Ambulatory care | Experimental | Ambulatory care : Outpatient management of radiological treatment for HCC and iCCA |
|
| Arm Conventional inpatient care | Other | Conventional inpatient care : Conventional inpatient management for radiological treatment of HCC and iCCA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ambulatory care | Other | Patients with Hepato cellular carcinoma (HCC) and Intrahepatic cholangiocarcinoma (iCCA) treated by transarterial chemoembolization (TACE) or transarterial radioembolization (TARE) 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 72 hours after treatment procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability (quantitative) | Proportion of consenting patients and description of refusals | 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. |
Not provided
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.
Patient with HCC or iCCA eligible for intra-arterial treatment (transarterial chemoembolization [TACE] or transarterial radioembolization [TARE]), with no prior intra-arterial treatment of the same type as the one planned in the trial:
If TACE is proposed at the multidisciplinary tumour board (RCP):
If treatment by TARE proposed in RCP:
Patient affiliated to or benefiting from a social security scheme
Patient having signed an informed consent form
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christophe AUBE, Pr | Contact | +33(0)24-135-4281 | ChAube@chu-angers.fr | |
| Sandra MERZEAU | Contact | +33(0)24-135-5970 | SaMerzeau@chu-angers.fr |
| Name | Affiliation | Role |
|---|---|---|
| Christophe AUBE, Pr | University Hospital, Angers | Principal Investigator |
| Jules GREGORY, Assoc Pr | Beaujon Hospital (APHP) - Paris cité University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University hospital of Amiens | Recruiting | Amiens | 80054 | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Conventional inpatient care | Other | Patients with Hepato cellular carcinoma (HCC) and Intrahepatic cholangiocarcinoma treated by transarterial chemoembolization (TACE) or transarterial radioembolization (TARE) are managed on an inpatient basis: conventional hospitalization. |
|
| 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. | 32 months |
| Adoption (qualitative) | Thematic analysis of verbatims collected during focus groups with centers | 36 months |
| Relevance (reasons for refusal) | Characteristics of patients whose inclusion in the protocol was refused by the patient/carer. | 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. | 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. | One year after the end of inclusions |
| Reach (Quantitative) | Patient-related factors associated with ambulatory care pathway failure (Indication; Techniques; Tolerance of organization). | 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 | 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 | One year after the end of inclusions |
| Comparing the organizations (Pain) | Visual analogue scale (VAS) for pain : 0 ('no pain') to 10 ('pain as bad as it could possibly be') | 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) | 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 | 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) | 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) | Month 6 |
| Comparing the organizations (Technical succes) | 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) | Month2/Month3 visit, Month 6 |
| Factors for patient satisfaction (HADS) | Anxiety and depression scale (HADS) | 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). | At inclusion visit (pre-treatment) |
| Factors for patient satisfaction (Treatment characteristics) |
| Day of treatment procedure |
| Factors for patient satisfaction (socioeconomic) | Socioeconomic level | At inclusion visit (pre-treatment) |
| Factors for patient satisfaction (travel) | Home-hospital travel time | At inclusion visit (pre-treatment) |
| Factors for patient satisfaction (comorbidities) | Comorbidities | At inclusion visit (pre-treatment) |
| Factors for patient satisfaction (ECOG) | Clinical status (ECOG) | 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) | 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) | 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 | 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) | within 72 hours post-procedure |
| University hospital of Angers | Recruiting | Angers | 49933 | France |
|
| University hospital of Besançon | Recruiting | Besançon | 25030 | France |
|
| Hospital of Avicennes (AP-HP) | Recruiting | Bobigny | France |
|
| University hospital of Brest | Recruiting | Brest | 29609 | France |
|
| Hospital of Beaujon (AP-HP) | Recruiting | Clichy | 92110 | France |
|
| Hospital of Vendée | Recruiting | La Roche-sur-Yon | 85925 | France |
|
| University hospital of Grenoble-Alpes | Recruiting | La Tronche | 38700 | France |
|
| University hospital of Marseille (AP-HM) | Recruiting | Marseille | 13005 | France |
|
| Saint-Joseph Hospital | Recruiting | Marseille | 13008 | France |
|
| University hospital of Montpellier | Not yet recruiting | Montpellier | 34090 | France |
|
| University hospital of Nantes | Not yet recruiting | Nantes | 44093 | France |
|
| University hospital of Nice | Recruiting | Nice | 06202 | France |
|
| Saint-Antoine Hospital (AP-HP) | Recruiting | Paris | 75012 | France |
|
| Hospital of Pitié-Salpétrière (AP-HP) | Recruiting | Paris | 75013 | France |
|
| Hospital of Cochin (AP-HP) | Recruiting | Paris | 75014 | France |
|
| Univesity hospital of Bordeaux | Not yet recruiting | Pessac | 33607 | France |
|
| University hospital of Toulouse | Recruiting | Toulouse | 31059 | France |
|
| Institut Gustave Roussy (IGR) | Recruiting | Villejuif | 94805 | France |
|
| ID | Term |
|---|---|
| D018281 | Cholangiocarcinoma |
| D017060 | Patient Satisfaction |
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000553 | Ambulatory Care |
| ID | Term |
|---|---|
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
Not provided
Not provided