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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
206
Patients with Hepato cellular carcinoma (HCC) 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.
Patients with Hepato cellular carcinoma (HCC) treated by chemo-embolization (CEH) or radioembolization (REH) are managed on an inpatient basis: conventional hospitalization.
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
...and 6 more locations
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
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)
4. 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
Scope (Quantitative)
Patient-related factors associated with ambulatory care pathway failure (Indication; Techniques; Tolerance of organization).
Time frame: One year after the end of inclusions
Scope (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
Scope (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 surgery, evening after surgery and 10 days after 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 treatment
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 treatment
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
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