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

NCT02857400 | Completed

• 1 other identifier: 16GENE11
• Study Type: interventional
• Target: 667
• Locations: 1 country
• Sites: 3

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

Conditions

METASTATIC CANCER

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Comparison of the 2 standard of care (current and CREDO) regarding subject' satisfaction

  up to 12 months

• Comparison of the 2 standard of care (current and CREDO) regarding subject's quality of life

  up to 12 months

• Identification of the conformity of the standard of care regarding the place of care

  up to 12 months

• To quantify the caregiver burden in the 2 standard of care (current and CREDO)

  up to 12 months

• To assess the medical and economic consequences of the 2 standard of care (current and CREDO)

  up to 12 months

Study Arms (2)

Arm A (standard)

OTHER

Other: current standard of care

Arm B (experimental)

EXPERIMENTAL

Other: CREDO standard of care

Interventions

current standard of care OTHER

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

Arm A (standard)

CREDO standard of care OTHER

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

Arm B (experimental)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Subject included in another trial evaluating the pathways care
• Pregnant or breastfeedings women
• Subject law protected

Sponsors & Collaborators

• Institut Claudius Regaud: lead

Study Sites (3)

Centre Hospitalier Auch

Auch, 32008, France

Location

Hopital Rangueil

Toulouse, 31 059, France

Location

Institut Claudius Regaud

Toulouse, 31059, France

Location

Related Publications (1)

• 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.

  PMID: 36717134 BACKGROUND

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marie-Eve ROUGE BUGAT, MD

  Institut Claudius Regaud

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2016
• First Posted: August 5, 2016
• Study Start: July 21, 2017
• Primary Completion: August 30, 2022
• Study Completion: August 30, 2022
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)