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NCT Number: NCT06443138

Preparation for Medical and Surgical Procedures in Oncogeriatry.

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.

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Key information

Conditions

Geriatric Oncology Neoplasms

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Nice

Nice, France

Location status: Recruiting

Location contact

frederic Chorin, PhD

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Maximal walking distance to 6 -MWT

    Time frame: at inclusion

    Metres walked during 6 minutes

  2. Maximal walking distance to 6 -MWT

    Time frame: at 4 weeks

    Metres walked during the test

  3. Maximal walking distance to 6 -MWT

    Time frame: at 8 weeks

    Metres walked during the test

  4. Maximal walking distance to 6 -MWT

    Time frame: at 16 weeks

    Metres walked during the test

Secondary outcomes

  1. EORTC-QLQC30

    Time frame: at inclusion, 4 weeks, 8 weeks, 16 weeks

    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.

  2. Fatigue scale (MFI-20)

    Time frame: at inclusion, 4 weeks, 8 weeks, 16 weeks

    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.

  3. Internationnal Physiqual activity questionaire (IPAQ-short)

    Time frame: at inclusion, 4 weeks, 8 weeks, 16 weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Frédéric Chorin

CONTACT

[email protected]

Rabia Boulahssass, MD

CONTACT

[email protected]

04 92 03 41 94

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

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

Acronym: PRIMECHO

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jun 5, 2024
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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