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

METASTATIC CANCER Clinical Trial

— CREDO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02857400
• Other study ID #: 16GENE11
• Status: Completed
• Phase: N/A
• Start date: July 21, 2017
• Est. completion date: August 30, 2022

Study information

• Verified date: September 2022
• Source: Institut Claudius Regaud
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 667
• Est. completion date: August 30, 2022
• Est. primary completion date: August 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• METASTATIC CANCER
• Neoplasm Metastasis

Intervention

Other:
• current standard of care
connection documentation faxed to GP (General practitioner) on the day of patient's discharge
• CREDO standard of care
organized consultation "return home" between patient, GP DESC (diploma of complementary specialized study) and patient's referent GP

Locations

Country	Name	City	State
France	Centre Hospitalier Auch	Auch
France	Hopital Rangueil	Toulouse
France	Institut Claudius Regaud	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Institut Claudius Regaud

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Comparison of the 2 standard of care (current and CREDO) regarding subject' satisfaction	phone call , specific question	up to 12 months
Secondary	Comparison of the 2 standard of care (current and CREDO) regarding subject's quality of life	quality of life questionnaire	up to 12 months
Secondary	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
Secondary	To quantify the caregiver burden in the 2 standard of care (current and CREDO)	Zarit Burden Interview	up to 12 months
Secondary	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