Preparation for Medical and Surgical Procedures in Oncogeriatry.

Geriatric Oncology Clinical Trial

— PRIMECHO  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06443138
• Other study ID #: 23-AOIP-03
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 10, 2024
• Est. completion date: September 10, 2026

Study information

• Verified date: May 2024
• Source: Centre Hospitalier Universitaire de Nice
• Contact: Rabia Boulahssass, MD
• Phone: 04 92 03 41 94
• Email: boulahssass.r[@]chu-nice.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: September 10, 2026
• Est. primary completion date: September 10, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Geriatric Oncology
• Neoplasms

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximal walking distance to 6 -MWT	Metres walked during 6 minutes	at inclusion
Primary	Maximal walking distance to 6 -MWT	Metres walked during the test	at 4 weeks
Primary	Maximal walking distance to 6 -MWT	Metres walked during the test	at 8 weeks
Primary	Maximal walking distance to 6 -MWT	Metres walked during the test	at 16 weeks
Secondary	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
Secondary	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
Secondary	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