Outpatient Care Pathway for Patients Treated Intra-arterially for Primary Liver Cancer
- Conditions
- Hepato Cellular Carcinoma (HCC)
- Registration Number
- NCT06990659
- Lead Sponsor
- University Hospital, Angers
- Brief Summary
Randomized trial comparing two care organizations (outpatient versus conventional inpatient care) using a mixed method (quantitative and qualitative data and analysis).
The protocol involves randomization between an ambulatory group and a conventional hospitalization group. Patients will be monitored for 7 months to assess satisfaction, complications and treatment efficacy. A qualitative study will be carried out to understand the obstacles and facilitate implementation of the ambulatory pathway. A medico-economic analysis will accompany this study to assess the financial impact of adopting the ambulatory pathway. The expected results will help determine the best management strategy for these patients.
The study's hypotheses are that performing intra-arterial treatments for primary liver cancer on an outpatient basis, combined with telephone follow-up, will improve patient satisfaction with their care, and that analysis of the implementation of this outpatient pathway will help improve the pathway and facilitate its implementation at other sites, by identifying obstacles and solutions.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 206
- Age ≥ 18 years
- HCC or CCi diagnosed according to the criteria of the European Association for the Study of the Liver (2024) or histologically proven.
- HCC or CCi naive to intra-arterial treatment. HCC 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 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 CCi)
- 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
- Technical contraindication or morphological elements of predictable technical difficulty
- Chronic renal insufficiency (Clairance < 30 ml/min)
- Known allergy to a contrast agent or chemotherapy agent
- Patient unable to be a candidate for outpatient management
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Overall patient satisfaction 72 hours after treatment procedure 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.
- Secondary Outcome Measures
Name Time Method Comparing the organizations (Technical succes) Month2/Month3 visit, Month 6 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)
Factors for patient satisfaction (HADS) Inclusion, Admission before surgery and 72 hours after treatment Anxiety and depression scale (HADS)
Factors for patient satisfaction (Disease characteristics) At inclusion visit (pre-treatment) Barcelona Clinic Liver Cancer (BCLC) classification stage, sarcopenia (based on imaging).
Comparing the organizations (Complications) Month 6 Complications according to the Common Terminology Criteria for Adverse Events (CTCAE) V5.0.5 Items from 1 (mild) to 5 (death)
Scope (Quantitative) One year after the end of inclusions Patient-related factors associated with ambulatory care pathway failure (Indication; Techniques; Tolerance of organization).
Scope (Qualitative for centers) One year after the end of inclusions 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
Scope (Qualitative for patients) One year after the end of inclusions 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
Comparing the organizations (Comfort and satisfaction) 72 hours after treatment 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)Comparing the organizations (Quality of life) At inclusion visit (pre-treatment), Day 7, Month2/Month3 visit Medical Outcome Study Short Form 12 (SF-12) A score \>50 indicates above-average health-related quality of life
Comparing the organizations (General condition) At inclusion visit (pre-treatment), Month2/Month3 visit 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)
Factors for patient satisfaction (Treatment characteristics) Day of treatment procedure 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.Factors for patient satisfaction (socioeconomic) At inclusion visit (pre-treatment) Socioeconomic level
Factors for patient satisfaction (travel) At inclusion visit (pre-treatment) Home-hospital travel time
Factors for patient satisfaction (comorbidities) At inclusion visit (pre-treatment) Comorbidities
Factors for patient satisfaction (ECOG) At inclusion visit (pre-treatment) Clinical status (ECOG)
Factors for patient satisfaction (Quality of life) At inclusion visit (pre-treatment), Day 7, Month 2/Month3 Questionnary of quality of life = Medical Outcome Study Short Form 12 (SF-12)
Total cost of each treatment pathway From day of treatment to Month 2/Month 3 visit From the community, health insurance and hospital perspective (depending on the type of treatment received)
Budgetary impact 5 years after study 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
Acceptability (quantitative) At inclusion visit (pre-treatment) Proportion of consenting patients and description of refusals
Acceptability (qualitative) At inclusion visit (pre-treatment) Thematic analysis of individual research interviews with a sample of patients included in both arms of the study.
4. Adoption (quantitative) 32 months Number of outpatient courses completed compared with the number of scheduled courses; number of candidate, open and active centers.
Adoption (qualitative) 36 months Thematic analysis of verbatims collected during focus groups with centers
Relevance (reasons for refusal) 24 months Characteristics of patients whose inclusion in the protocol was refused by the patient/carer.
Relevance (patient expectations) 36 months 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.
Feasibility of outpatient care One year after the end of inclusions 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.
Trial Locations
- Locations (16)
University hospital of Amiens
🇫🇷Amiens, France
University hospital of Angers
🇫🇷Angers, France
University hospital of Besançon
🇫🇷Besançon, France
Hospital of Avicennes (AP-HP)
🇫🇷Bobigny, France
University hospital of Brest
🇫🇷Brest, France
University hospital of Clermont-Ferrand
🇫🇷Clermont-Ferrand, France
Hospital of Beaujon (AP-HP)
🇫🇷Clichy, France
Hospital of Vendée
🇫🇷La Roche-sur-Yon, France
University hospital of Grenoble-Alpes
🇫🇷La Tronche, France
University hospital of Montpellier
🇫🇷Montpellier, France
Nantes
🇫🇷Nantes, France
University hospital of Nice
🇫🇷Nice, France
Hospital of Pitié-Salpétrière (AP-HP)
🇫🇷Paris, France
Hospital of Cochin (AP-HP)
🇫🇷Paris, France
Univesity hospital of Bordeaux
🇫🇷Pessac, France
Institut Gustave Roussy (IGR)
🇫🇷Villejuif, France