ICOPE Program Feasibility in the Management of Myeloma Patients

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 70 Years and Over
Gender All
More 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06247189
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University Hospital, Toulouse
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Gilles BOURGADE
Principal Investigator Affiliation University Hospital, Toulouse
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Frailty, Multiple Myeloma
Additional Details

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.

Arms & Interventions

Arms

Experimental: ICOPE Monitor Program

Evaluation at inclusion and re-evaluation monthly.

Interventions

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

CHU de Toulouse, Toulouse, France

Status

Address

CHU de Toulouse

Toulouse, ,

Site Contact

Gilles BOURGADE

bourgade.g@chu-toulouse.fr

06 04 54 59 39 #+33