Evaluation of an Organized Consultation "Return Home" of Patients With a Cancer (CREDO) (CREDO)
Primary Purpose
METASTATIC CANCER
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
current standard of care
CREDO standard of care
Sponsored by
About this trial
This is an interventional health services research trial for METASTATIC CANCER
Eligibility Criteria
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
Sites / Locations
- Centre Hospitalier Auch
- Hopital Rangueil
- Institut Claudius Regaud
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Arm A (standard)
Arm B (experimental)
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Comparison of the 2 standard of care (current and CREDO) regarding subject' satisfaction
phone call , specific question
Comparison of the 2 standard of care (current and CREDO) regarding subject's quality of life
quality of life questionnaire
Identification of the conformity of the standard of care regarding the place of care
Comparison with the initial predefined place of standard of care
To quantify the caregiver burden in the 2 standard of care (current and CREDO)
Zarit Burden Interview
To assess the medical and economic consequences of the 2 standard of care (current and CREDO)
A cost effectiveness analysis will be performed
Full Information
NCT ID
NCT02857400
First Posted
July 28, 2016
Last Updated
September 28, 2022
Sponsor
Institut Claudius Regaud
1. Study Identification
Unique Protocol Identification Number
NCT02857400
Brief Title
Evaluation of an Organized Consultation "Return Home" of Patients With a Cancer (CREDO)
Acronym
CREDO
Official Title
Evaluation of an Organized Consultation "Return Home" of Patients With a Cancer (CREDO)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
July 21, 2017 (Actual)
Primary Completion Date
August 30, 2022 (Actual)
Study Completion Date
August 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Claudius Regaud
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
METASTATIC CANCER
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
667 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm A (standard)
Arm Type
Other
Arm Title
Arm B (experimental)
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
current standard of care
Intervention Description
connection documentation faxed to GP (General practitioner) on the day of patient's discharge
Intervention Type
Other
Intervention Name(s)
CREDO standard of care
Intervention Description
organized consultation "return home" between patient, GP DESC (diploma of complementary specialized study) and patient's referent GP
Primary Outcome Measure Information:
Title
Evaluation of an organized consultation "return home" of patients with a metastatic cancer
Description
Evaluation of number of non planned consultation and hospitalization compared to current standard of care
Time Frame
up to 12 months
Secondary Outcome Measure Information:
Title
Comparison of the 2 standard of care (current and CREDO) regarding subject' satisfaction
Description
phone call , specific question
Time Frame
up to 12 months
Title
Comparison of the 2 standard of care (current and CREDO) regarding subject's quality of life
Description
quality of life questionnaire
Time Frame
up to 12 months
Title
Identification of the conformity of the standard of care regarding the place of care
Description
Comparison with the initial predefined place of standard of care
Time Frame
up to 12 months
Title
To quantify the caregiver burden in the 2 standard of care (current and CREDO)
Description
Zarit Burden Interview
Time Frame
up to 12 months
Title
To assess the medical and economic consequences of the 2 standard of care (current and CREDO)
Description
A cost effectiveness analysis will be performed
Time Frame
up to 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie-Eve ROUGE BUGAT, MD
Organizational Affiliation
Institut Claudius Regaud
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Auch
City
Auch
ZIP/Postal Code
32008
Country
France
Facility Name
Hopital Rangueil
City
Toulouse
ZIP/Postal Code
31 059
Country
France
Facility Name
Institut Claudius Regaud
City
Toulouse
ZIP/Postal Code
31059
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of an Organized Consultation "Return Home" of Patients With a Cancer (CREDO)
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