Preparation for Medical and Surgical Procedures in Oncogeriatry.

NCT06443138 | Recruiting

• 1 other identifier: 23-AOIP-03
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Geriatric Oncology

Keywords

ederly; cancer

Outcome Measures

Primary Outcomes (4)

• Maximal walking distance to 6 -MWT

  Metres walked during 6 minutes

  at inclusion

• Maximal walking distance to 6 -MWT

  Metres walked during the test

  at 4 weeks

• Maximal walking distance to 6 -MWT

  Metres walked during the test

  at 8 weeks

• Maximal walking distance to 6 -MWT

  Metres walked during the test

  at 16 weeks

Secondary Outcomes (3)

• EORTC-QLQC30

  at inclusion, 4 weeks, 8 weeks, 16 weeks

• Fatigue scale (MFI-20)

  at inclusion, 4 weeks, 8 weeks, 16 weeks

• Internationnal Physiqual activity questionaire (IPAQ-short)

  at inclusion, 4 weeks, 8 weeks, 16 weeks

Study Arms (1)

Personalized pre-habilitation program

EXPERIMENTAL

Other: Personalized pre-habilitation program

Interventions

Personalized pre-habilitation program OTHER

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.

Personalized pre-habilitation program

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Inability to walk or perform unsupervised exercises.
• Vulnerable people

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de Nice

Nice, France

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

• Rabia Boulahssass, MD

  Centre Hospitalier Universitaire de Nice

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rabia Boulahssass, MD

CONTACT

04 92 03 41 94; boulahssass.r@chu-nice.fr

Frédéric Chorin

CONTACT

chorin.f@chu-nice.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Implementation of a personalized pre-habilitation program at home before surgery

Study Record Dates

• First Submitted: May 23, 2024
• First Posted: June 5, 2024
• Study Start: November 6, 2024
• Primary Completion (Estimated): November 10, 2027
• Study Completion (Estimated): November 10, 2027
• Last Updated: March 19, 2026

Record last verified: 2026-03

Locations

FR (1)