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Clinical Trial NCT06443138 (PRIMECHO) for Geriatric Oncology is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Preparation for Medical and Surgical Procedures in Oncogeriatry. (PRIMECHO) 20 Senior-Focused

Recruiting
Clinical Trial NCT06443138 (PRIMECHO) is an interventional study for Geriatric Oncology that is recruiting. It started on 6 November 2024 with plans to enroll 20 participants. Led by Centre Hospitalier Universitaire de Nice, it is expected to complete by 10 November 2027. The latest data from ClinicalTrials.gov was last updated on 19 March 2026.
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 ...

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Official Title

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

Conditions
Geriatric Oncology
Other Study IDs
  • PRIMECHO
  • 23-AOIP-03
NCT ID Number
NCT06443138
Start Date (Actual)
2024-11-06
Last Update Posted
2026-03-19
Completion Date (Estimated)
2027-11-10
Enrollment (Estimated)
20
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
ederly
cancer
Primary Purpose
Prevention
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalPersonalized pre-habilitation program
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
Outcome MeasureMeasure DescriptionTime 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 MeasureMeasure DescriptionTime 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
Participation Assistant
Eligibility Criteria

Eligible Ages
Older Adult
Minimum Age
70 Years
Eligible Sexes
All
  • 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.

  • Inability to walk or perform unsupervised exercises.
  • Vulnerable people
Centre Hospitalier Universitaire de Nice logoCentre Hospitalier Universitaire de Nice
Study Central Contact
Contact: Rabia Boulahssass, MD, 04 92 03 41 94, [email protected]
Contact: Frédéric Chorin, [email protected]
1 Study Locations in 1 Countries
CHU de Nice, Nice, France
frederic Chorin, PhD, Contact
Recruiting