Preparation for Medical and Surgical Procedures in Oncogeriatry.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Personalized pre-habilitation program.
- Who it may be relevant to
- Registry conditions: Geriatric Oncology. Basic parameters: from 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Preparation for Medical and Surgical Procedures in Oncogeriatry. Pilote Study PRIMECHO
Overview
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.
Interventions
- Other Personalized pre-habilitation program
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.
Primary outcome measures
- Maximal walking distance to 6 -MWT [Time frame: at inclusion]
- Maximal walking distance to 6 -MWT [Time frame: at 4 weeks]
- Maximal walking distance to 6 -MWT [Time frame: at 8 weeks]
- Maximal walking distance to 6 -MWT [Time frame: at 16 weeks]
Secondary outcome measures (3)
- EORTC-QLQC30 [Time frame: at inclusion, 4 weeks, 8 weeks, 16 weeks]
- Fatigue scale (MFI-20) [Time frame: at inclusion, 4 weeks, 8 weeks, 16 weeks]
- Internationnal Physiqual activity questionaire (IPAQ-short) [Time frame: at inclusion, 4 weeks, 8 weeks, 16 weeks]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
France · 1 center
- CHU de Nice — Nice
Identifiers
NCT: NCT06443138 · 23-AOIP-03