Monthly ICOPE monitoring for older adults with multiple myeloma
Onco-ICOPE: ICOPE Program Feasibility in the Management of Myeloma Patients Over 70 Years
NA · University Hospital, Toulouse · NCT06247189
We will test whether monthly ICOPE monitoring can catch early signs of functional decline and help maintain independence in people over 70 with multiple myeloma.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 70 Years and up |
| Sex | All |
| Sponsor | University Hospital, Toulouse (other) |
| Locations | 1 site (Toulouse) |
| Trial ID | NCT06247189 on ClinicalTrials.gov |
What this trial studies
This single-center feasibility project adapts the WHO ICOPE MONITOR program to a monthly rhythm for elderly patients with multiple myeloma to detect earlier declines in intrinsic capacity across mobility, memory, nutrition, mood, vision, and hearing. At inclusion patients undergo step 1 assessments of functional autonomy, quality of life, a clinical exam, and hematologic data collection, then enter monthly digital monitoring via an app or chatbot. When abnormalities are detected, the protocol triggers further geriatric steps and individualized care plans to try to limit decline. The program targets patients able to use digital tools and is conducted at CHU de Toulouse.
Who should consider this trial
Good fit: Ideal candidates are people aged over 70 with multiple myeloma starting first- or second-line treatment who can read and speak French and use a smartphone, tablet, or computer (or have a caregiver who can).
Not a fit: Patients in palliative care, those under legal guardianship, unable to use digital tools or understand the program, or with very limited life expectancy are unlikely to benefit.
Why it matters
Potential benefit: If successful, this approach could detect problems earlier and enable timely, personalized interventions that help preserve independence and reduce treatment interruptions.
How similar studies have performed: The ICOPE framework has shown promise for monitoring older adults in other settings, but a monthly adaptation specifically for older myeloma patients is a novel approach without established results.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Toulouse
- CHU de Toulouse — Toulouse, France (RECRUITING)
Study contacts
- Principal investigator: Gilles BOURGADE — University Hospital, Toulouse
- Study coordinator: Gilles BOURGADE
- Email: bourgade.g@chu-toulouse.fr
- Phone: 06 04 54 59 39
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Frailty, Multiple Myeloma, ICOPE, multiple myeloma, older patients, follow-up, frailty, geriatric nursing