ICOPE Program Feasibility in the Management of Myeloma Patients

NCT ID: NCT06247189

Last Updated: 2025-12-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-03
• Study Completion Date: 2026-12-30

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.

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

Keywords

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

ICOPE Monitor Program

Evaluation at inclusion and re-evaluation monthly.

Group Type: EXPERIMENTAL

ICOPE Monitoring

Intervention Type: 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

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gilles BOURGADE

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

CHU de Toulouse

Toulouse, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Gilles BOURGADE

Role: CONTACT

Phone: 06 04 54 59 39

Email: bourgade.g@chu-toulouse.fr

Stéphanie LOZANO, MD

Role: CONTACT

Phone: 05 61 77 66 48

Email: lozano.stephanie@chu-toulouse.fr

Facility Contacts

Gilles BOURGADE

Role: primary

Stéphanie LOZANO, MD

Role: backup

Other Identifiers

RC31/22/0485

Identifier Type: -

Identifier Source: org_study_id