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Preparation for Medical and Surgical Procedures in Oncogeriatry.

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06443138
Acronym
PRIMECHO
Enrollment
20
Registered
2024-06-05
Start date
2026-09-11
Completion date
2028-09-11
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Geriatric Oncology

Keywords

ederly, cancer

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.

Interventions

OTHERPersonalized 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.

Sponsors

Centre Hospitalier Universitaire de Nice
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Maximal walking distance to 6 -MWTat inclusionMetres walked during 6 minutes

Secondary

MeasureTime frameDescription
EORTC-QLQC30at inclusion, 4 weeks, 8 weeks, 16 weeksQLQC30 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.
Fatigue scale (MFI-20)at inclusion, 4 weeks, 8 weeks, 16 weeksMultidiensional 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.
Internationnal Physiqual activity questionaire (IPAQ-short)at inclusion, 4 weeks, 8 weeks, 16 weeksThis 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.

Countries

France

Contacts

CONTACTRabia Boulahssass, MD
boulahssass.r@chu-nice.fr04 92 03 41 94
CONTACTFrédéric Chorin
chorin.f@chu-nice.fr
PRINCIPAL_INVESTIGATORRabia Boulahssass, MD

Centre Hospitalier Universitaire de Nice

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 15, 2026