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Trial Title:
Preparation for Medical and Surgical Procedures in Oncogeriatry.
NCT ID:
NCT06443138
Condition:
Geriatric Oncology
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
ederly
cancer
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Implementation of a personalized pre-habilitation program at home before surgery
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Personalized pre-habilitation program
Description:
Each patient will undergo 4 weeks of individualized pre-habilitation before surgery.
Each session (1 session per day) will be carried out autonomously by the patient at home,
via a dedicated application (Activiti Pro) installed on their tablet or smartphone.
Arm group label:
Personalized pre-habilitation program
Summary:
Surgical management is one of the most frequently used interventions in the treatment of
many cancers, but it can be associated with a high risk of postoperative complications.
The maintenance and optimization of functional abilities before, during and after
treatment are major for elderly cancer patients, as it is now well established that there
is a link between the level of functional capacity and the occurrence of these
complications.
The scientific literature shows that the benefits of pre- and post-operative training
programs, but these benefits only apply to a fraction of the patients adhering to the
programs. The modalities of intervention (training load, follow-up, etc.) as well as
patient involvement in these programs are major issues that need to be addressed to
optimize their benefits.
Individualizing pre-habilitation, on the basis of the management of the training load,
and therefore objective fatigue, would enable better patient adherence to the program,
and optimize its benefits.
In this context, the PRIMECHO project aims to individualize pre-habilitation in order to
improve functional of patients in the pre-habilitation or accelerated recovery after
surgery phase. The aim is for the patient to be in optimum physical condition at the time
of the intervention or treatment.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patient aged 70 or over
- Cancer patient with planned surgery,
- Mini Mental State Examination score greater than or equal to 24 (performed in
advance by the geriatrician),
- Patient affiliated to or benefiting from a social security insurance
- Signed free and informed consent.
Exclusion Criteria:
- Inability to walk or perform unsupervised exercises.
- Vulnerable people
Gender:
All
Minimum age:
70 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
October 10, 2024
Completion date:
October 10, 2026
Lead sponsor:
Agency:
Centre Hospitalier Universitaire de Nice
Agency class:
Other
Source:
Centre Hospitalier Universitaire de Nice
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06443138
