ICOPE Program Feasibility in the Management of Myeloma Patients (Onco-ICOPE)

Onco-ICOPE: ICOPE Program Feasibility in the Management of Myeloma Patients Over 70 Years

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.

Study Overview

• Status: Recruiting
• Conditions: Multiple Myeloma; Frailty
• Intervention / Treatment: Other: ICOPE Monitoring

Detailed Description

With a median age of 70 years at diagnosis, multiple myeloma is a disease of the elderly, with 30-40% of patients over 75 years. Patients identified as frail have a higher risk of mortality, an increase in non-haematological adverse events and a significantly higher risk of treatment discontinuation. Comprehensive geriatric assessment is time-consuming, difficult to follow up regularly, and not routinely offered. However, this population presents an increased risk of loss of autonomy, linked both to age and treatment. For all seniors, ambition of ICOPE (Integrated Care for Older People) program is healthy aging by developing and maintaining their functional ability. To achieve this, the World Health Organization (WHO) recommends monitoring the evolution of intrinsic capacity, every 4 to 6 months. This covers 6 areas: mobility, memory, nutrition, psychological state, vision and hearing. This program is divided into 5 steps (Annex1). Adapting this monitoring to a monthly rhythm will prevent loss of autonomy in this population at greater risk. Early detection allows implementation of early and individualized care plan, thus limiting decline which could prove irreversible.

At inclusion, patient will be included in ICOPE MONITOR program. During this visit, the patient will undergo step 1 of the program, an evaluation of functional autonomy and quality of life, as well as a clinical examination and a collection of hematological data. If anomalies are detected, following steps (2-3-4-5) will be done.

Monthly, patient will carry out a screening (Step1) on his own. In case of abnormalities, following steps can be performed.

Visits will be made every 3 months with a screening (Step1), and if necessary, following steps, an evaluation of autonomy and an evaluation of quality of life.

Patients will be followed for 12 months. At the last visit the patient and the nurse will answer satisfaction questionnaires.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gilles BOURGADE; Phone Number: +33 06 04 54 59 39; Email: bourgade.g@chu-toulouse.fr
• Study Contact Backup: Name: Stéphanie LOZANO, MD; Phone Number: +33 05 61 77 66 48; Email: lozano.stephanie@chu-toulouse.fr

Study Locations

• France
  • Toulouse, France
    • Recruiting
    • CHU de Toulouse
    • Sub-Investigator: Stéphanie LOZANO
    • Contact: Gilles BOURGADE; Phone Number: +33 06 04 54 59 39; Email: bourgade.g@chu-toulouse.fr
    • Contact: Stéphanie LOZANO, MD; Phone Number: +33 05 61 77 66 48; Email: lozano.stephanie@chu-toulouse.fr
    • Principal Investigator: Gilles BOURGADE

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.
• Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research)

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ICOPE Monitor Program; Evaluation at inclusion and re-evaluation monthly.	Other: ICOPE Monitoring; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Gilles BOURGADE, University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2025
• Primary Completion (Estimated): December 3, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: January 30, 2024
• First Submitted That Met QC Criteria: January 30, 2024
• First Posted (Actual): February 7, 2024

Study Record Updates

• Last Update Posted (Actual): December 22, 2025
• Last Update Submitted That Met QC Criteria: December 15, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: frailty; follow-up; older patients; multiple myeloma; geriatric nursing; ICOPE
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Neoplasms, Plasma Cell; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Frailty; Multiple Myeloma
• Other Study ID Numbers: RC31/22/0485

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