METASTATIC CANCER
Conditions
Brief summary
Prospective, open label, randomized and multicentric study evaluating the efficacy of an organized consultation "return home" compared to a current standard of care in patient hospitalized due to metastatic solid tumor cancer. Subject will be randomized (1:1) as described below : • Arm A (standard) : current standard of care ; connection documentation faxed to GP ( General practitioner) on the day of patient's discharge Arm B (experimental) : CREDO standard of care, organized consultation "return home" between patient, GP DESC (diploma of complementary specialized study) and patient's referent GP
Interventions
connection documentation faxed to GP (General practitioner) on the day of patient's discharge
OTHERCREDO standard of care
organized consultation "return home" between patient, GP DESC (diploma of complementary specialized study) and patient's referent GP
Sponsors
Institut Claudius Regaud
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age \> or = 18 years old 2. Subject hospitalized in an oncology dedicated center for administration of the first chemotherapy cycle. 3. Subject with metastatic solid tumor whatever the organ 4. subject planned to be discharged home after chemotherapy administration 5. Affiliated to the French social security system. 6. Subjects must provide written informed consent prior to any study-specific procedure or assessment
Exclusion criteria
1. Subject included in another trial evaluating the pathways care 2. Pregnant or breastfeedings women 3. Subject law protected
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of an organized consultation "return home" of patients with a metastatic cancer | up to 12 months | Evaluation of number of non planned consultation and hospitalization compared to current standard of care |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of the 2 standard of care (current and CREDO) regarding subject' satisfaction | up to 12 months | phone call , specific question |
| Comparison of the 2 standard of care (current and CREDO) regarding subject's quality of life | up to 12 months | quality of life questionnaire |
| Identification of the conformity of the standard of care regarding the place of care | up to 12 months | Comparison with the initial predefined place of standard of care |
| To quantify the caregiver burden in the 2 standard of care (current and CREDO) | up to 12 months | Zarit Burden Interview |
| To assess the medical and economic consequences of the 2 standard of care (current and CREDO) | up to 12 months | A cost effectiveness analysis will be performed |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORMarie-Eve ROUGE BUGAT, MD
Institut Claudius Regaud
Outcome results
None listed