Preparation for Medical and Surgical Procedures in Oncogeriatry. (PRIMECHO)

Preparation for Medical and Surgical Procedures in Oncogeriatry. Pilote Study PRIMECHO

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.

Study Overview

• Status: Recruiting
• Conditions: Geriatric Oncology
• Intervention / Treatment: Other: Personalized pre-habilitation program

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rabia Boulahssass, MD; Phone Number: 04 92 03 41 94; Email: boulahssass.r@chu-nice.fr
• Study Contact Backup: Name: Frédéric Chorin; Email: chorin.f@chu-nice.fr

Study Locations

• France
  • Nice, France
    • Recruiting
    • Chu de Nice
    • Contact: frederic Chorin, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Personalized pre-habilitation program	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
EORTC-QLQC30	QLQC30 is a 30-item instrument designed to measure quality of life in all cancer patients. It contains 30 questions and assesses the quality of life of oncological patients multidimensionally over 10 subscales. All sub-scales and the 6 individual items have a score range from 0 to 100 points. A higher score represents better function and a higher quality of life. In the symptom subscale, however, a higher score represents a higher level of symptoms or problems. Since there is no total score, all subscales and the individual items must be considered individually and evaluated using normative data.	at inclusion, 4 weeks, 8 weeks, 16 weeks
Fatigue scale (MFI-20)	Multidiensional Fatigue Inventory-20 (MFI-20) questionnaire. 5 scales. Higher scores means worse outcome. General Fatigue dimension: Minimum value: 4. Maximum Value: 20. Physical fatigue dimension: Minimum value: 4. Maximum Value: 20. Reduced activity dimension: Minimum value: 4. Maximum Value: 20. Reduced motivation dimension: Minimum value: 4. Maximum Value: 20. Mental fatigue dimension: Minimum value: 4. Maximum Value: 20.	at inclusion, 4 weeks, 8 weeks, 16 weeks
Internationnal Physiqual activity questionaire (IPAQ-short)	This questionnaire assesses overall physical activity and sedentary time over the last seven days. The questionnaire looks at intense, moderate and walking activity, as well as time spent sitting down (sedentary lifestyle), whether during leisure activities, at work, in daily life or during transport. The questionnaire composed with 7 questions classifies the subject according to 3 levels of activity: inactive, moderate, high.	at inclusion, 4 weeks, 8 weeks, 16 weeks

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice
• Investigators: Principal Investigator: Rabia Boulahssass, MD, Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2024
• Primary Completion (Estimated): November 10, 2027
• Study Completion (Estimated): November 10, 2027

Study Registration Dates

• First Submitted: May 23, 2024
• First Submitted That Met QC Criteria: May 29, 2024
• First Posted (Actual): June 5, 2024

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: cancer; ederly
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 23-AOIP-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No