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

NCT ID: NCT02857400

Last Updated: 2022-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

667 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-21

Study Completion Date

2022-08-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

METASTATIC CANCER

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm A (standard)

Group Type OTHER

current standard of care

Intervention Type OTHER

connection documentation faxed to GP (General practitioner) on the day of patient's discharge

Arm B (experimental)

Group Type EXPERIMENTAL

CREDO standard of care

Intervention Type OTHER

organized consultation "return home" between patient, GP DESC (diploma of complementary specialized study) and patient's referent GP

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

current standard of care

connection documentation faxed to GP (General practitioner) on the day of patient's discharge

Intervention Type OTHER

CREDO standard of care

organized consultation "return home" between patient, GP DESC (diploma of complementary specialized study) and patient's referent GP

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Institut Claudius Regaud

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Marie-Eve ROUGE BUGAT, MD

Role: PRINCIPAL_INVESTIGATOR

Institut Claudius Regaud

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Centre Hospitalier Auch

Auch, , France

Site Status

Hopital Rangueil

Toulouse, , France

Site Status

Institut Claudius Regaud

Toulouse, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

Gimenez L, Grosclaude P, Druel V, Costa N, Delpierre C, Molinier L, Delord JP, Rouge Bugat ME. Study protocol of the CREDO randomised controlled trial: evaluation of a structured return home consultation for patients suffering from metastaticcancer. BMJ Open. 2023 Jan 30;13(1):e062219. doi: 10.1136/bmjopen-2022-062219.

Reference Type DERIVED
PMID: 36717134 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

16GENE11

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.