Clinical trial NCT06443138: Preparation for Medical and Surgical Procedures in Oncogeriatry.
Official title: Preparation for Medical and Surgical Procedures in Oncogeriatry. Pilote Study PRIMECHO
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Geriatric Oncology
Keywords: ederly
cancer
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2024-06-05
Enrollment: 20
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Implementation of a personalized pre-habilitation program at home before surgery
Primary purpose: PREVENTION

Brief 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.


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

Primary outcomes:
measure: Maximal walking distance to 6 -MWT
timeFrame: at inclusion
measure: Maximal walking distance to 6 -MWT
timeFrame: at 4 weeks
measure: Maximal walking distance to 6 -MWT
timeFrame: at 8 weeks
measure: Maximal walking distance to 6 -MWT
timeFrame: at 16 weeks
Secondary outcomes:
measure: EORTC-QLQC30
timeFrame: at inclusion, 4 weeks, 8 weeks, 16 weeks
measure: Fatigue scale (MFI-20)
timeFrame: at inclusion, 4 weeks, 8 weeks, 16 weeks
measure: Internationnal Physiqual activity questionaire (IPAQ-short)
timeFrame: at inclusion, 4 weeks, 8 weeks, 16 weeks
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice
Study officials:
affiliation: Centre Hospitalier Universitaire de Nice
name: Rabia Boulahssass, MD
role: PRINCIPAL_INVESTIGATOR
References: