Evaluation of an Organized Consultation Return Home of Patients With a Cancer (CREDO)

Study Overview
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Brief Summary
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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

Official Title
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Evaluation of an Organized Consultation Return Home of Patients With a Cancer (CREDO)

Conditions
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METASTATIC CANCER

Intervention / Treatment
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* Other: current standard of care
* Other: CREDO standard of care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > or = 18 years old Subject hospitalized in an oncology dedicated center for administration of the first chemotherapy cycle. Subject with metastatic solid tumor whatever the organ subject planned to be discharged home after chemotherapy administration Affiliated to the French social security system. Subjects must provide written informed consent prior to any study-specific procedure or assessment Exclusion Criteria: Subject included in another trial evaluating the pathways care Pregnant or breastfeedings women Subject law protected

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Arm A (standard)<br> | Other: current standard of care<br>* connection documentation faxed to GP (General practitioner) on the day of patient's discharge<br>|
| Experimental: Arm B (experimental)<br> | Other: CREDO standard of care<br>* organized consultation return home between patient, GP DESC (diploma of complementary specialized study) and patient's referent GP<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of an organized consultation return home of patients with a metastatic cancer | Evaluation of number of non planned consultation and hospitalization compared to current standard of care | up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the 2 standard of care (current and CREDO) regarding subject' satisfaction | phone call , specific question | up to 12 months | 
| Comparison of the 2 standard of care (current and CREDO) regarding subject's quality of life | quality of life questionnaire | up to 12 months | 
| Identification of the conformity of the standard of care regarding the place of care | Comparison with the initial predefined place of standard of care | up to 12 months | 
| To quantify the caregiver burden in the 2 standard of care (current and CREDO) | Zarit Burden Interview | up to 12 months | 
| To assess the medical and economic consequences of the 2 standard of care (current and CREDO) | A cost effectiveness analysis will be performed | up to 12 months |