NCT06247189

ICOPE Program Feasibility in the Management of Myeloma Patients

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University Hospital, Toulouse · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Frailty
• Multiple Myeloma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-12-03
• Primary completion: 2026-12-03
• Completion: 2026-12-30
• First posted: 2024-02-07
• Last updated: 2025-12-22

Locations

1 site across 1 country: France