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

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

Study Overview

• Status: Completed
• Conditions: METASTATIC CANCER
• Intervention / Treatment: Other: current standard of care; Other: CREDO standard of care

• Study Type: Interventional
• Enrollment (Actual): 667
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Auch, France, 32008
    • Centre Hospitalier Auch
  • Toulouse, France, 31059
    • Institut Claudius Regaud
  • Toulouse, France, 31 059
    • Hopital Rangueil

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Institut Claudius Regaud
• Investigators: Principal Investigator: Marie-Eve ROUGE BUGAT, MD, Institut Claudius Regaud

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 21, 2017
• Primary Completion (ACTUAL): August 30, 2022
• Study Completion (ACTUAL): August 30, 2022

Study Registration Dates

• First Submitted: July 28, 2016
• First Submitted That Met QC Criteria: August 2, 2016
• First Posted (ESTIMATE): August 5, 2016

Study Record Updates

• Last Update Posted (ACTUAL): September 29, 2022
• Last Update Submitted That Met QC Criteria: September 28, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis
• Other Study ID Numbers: 16GENE11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No