ICOPE Program Feasibility in the Management of Myeloma Patients

Multiple Myeloma Clinical Trial

— Onco-ICOPE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06247189
• Other study ID #: RC31/22/0485
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2024
• Est. completion date: September 1, 2026

Study information

• Verified date: April 2024
• Source: University Hospital, Toulouse
• Contact: Gilles BOURGADE
• Phone: 06 04 54 59 39
• Email: bourgade.g[@]chu-toulouse.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: September 1, 2026
• Est. primary completion date: September 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Frailty
• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

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

Locations

Country	Name	City	State
France	CHU de Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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