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

Not Applicable

Completed

• Conditions: METASTATIC CANCER
• Interventions: Other: current standard of care; Other: CREDO standard of care

• Registration Number: NCT02857400
• Lead Sponsor: Institut Claudius Regaud

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-07-28
• Study First Submitted QC: 2016-08-02
• Study First Posted: 2016-08-05
• Study Start: 2017-07-21
• Primary Completion: 2022-08-30
• Study Completion: 2022-08-30
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-28
• Last Update Posted: 2022-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 667

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A (standard)	current standard of care	-
Arm B (experimental)	CREDO standard of care	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Comparison of the 2 standard of care (current and CREDO) regarding subject' satisfaction	up to 12 months	phone call , specific question
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
Comparison of the 2 standard of care (current and CREDO) regarding subject's quality of life	up to 12 months	quality of life questionnaire

Trial Locations

Locations (3)

Centre Hospitalier Auch; 🇫🇷 Auch, France

Hopital Rangueil; 🇫🇷 Toulouse, France

Institut Claudius Regaud; 🇫🇷 Toulouse, France