CHU de Toulouse
Toulouse, France
Location status: Recruiting
NCT Number: NCT06247189
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.
Interested in participating?
Request Info70 year and older
All sexes
Interventional
Not applicable
Toulouse, France
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 12 months
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.
Interested in participating?
Request InfoUniversity Hospital, Toulouse
Other
Onco-ICOPE: ICOPE Program Feasibility in the Management of Myeloma Patients Over 70 Years
Acronym: Onco-ICOPE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06099912
Blood Protein Disorders, Cardiovascular Diseases
Changchun, Jilin, China
View Trial DetailsNCT07829484
Falls, Frailty
Pamplona, Navarre, Spain
View Trial DetailsNCT07824700
Frailty, Pathologic Processes
Hong Kong
View Trial DetailsNCT06507527
Comorbidities and Coexisting Conditions, Complication
Barcelona, Spain
View Trial Details