ICOPE Program Feasibility in the Management of Myeloma Patients

NCT06247189 | Recruiting

• 1 other identifier: RC31/22/0485
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This project proposes to adapt monthly the existing ICOPE (Integrated Care for Older People) MONITOR program for elderly myeloma patients. This adaptation aims to detect earlier functional decline and prevent loss of autonomy.

Conditions

Frailty; Multiple Myeloma

Keywords

ICOPE; multiple myeloma; older patients; follow-up; frailty; geriatric nursing

Outcome Measures

Primary Outcomes (1)

• Feasibility of the implementation

  Feasibility will be assessed on patient adherence to ICOPE MONITOR program. An interruption of 3 or more consecutive Step 1 over one year, apart from death, will be considered a failure of adherence for the patient.

  12 months

Study Arms (1)

ICOPE Monitor Program

EXPERIMENTAL

Evaluation at inclusion and re-evaluation monthly.

Other: ICOPE Monitoring

Interventions

ICOPE Monitoring OTHER

At inclusion set up of the ICOPE monitor program on the patient's device and evaluation (all steps) of ICOPE Monitor program. Monthly, re-evaluation of the patient (Step 1 and others if necessary ) according to the ICOPE Monitor program

ICOPE Monitor Program

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Male or female aged over 70 years,
• Patient with multiple myeloma
• WHO performance status 0-3,
• Patient eligible for first- or second-line treatment
• Patient willing to participate in ICOPE MONITOR program
• Patient or caregiver able to use digital tools of ICOPE MONITOR: application or chatbot (computer or tablet or smartphone)
• Patient with a life expectancy of more than 3 months,
• Patient or caregiver able to understand, read and speak French
• Person affiliated or benefiting from a social security.

You may not qualify if:

• Patient in palliative care
• Patient participating in a study evaluating another frailty prevention program
• Patient unable to understand the study
• Patient under court protection, guardianship or curatorship,
• Patient refusal.

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

CHU de Toulouse

Toulouse, France

RECRUITING

MeSH Terms

Conditions

Frailty; Multiple Myeloma

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Gilles BOURGADE

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gilles BOURGADE

CONTACT

06 04 54 59 39; bourgade.g@chu-toulouse.fr

Stéphanie LOZANO, MD

CONTACT

05 61 77 66 48; lozano.stephanie@chu-toulouse.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2024
• First Posted: February 7, 2024
• Study Start: December 3, 2025
• Primary Completion (Estimated): December 3, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)