Geriatric OncologyPRIMECHONCT06443138
Preparation for Medical and Surgical Procedures in Oncogeriatry.
A study testing Personalized pre-habilitation program in people with Geriatric Oncology, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Geriatric Oncology
- What is being tested?
- Personalized pre-habilitation program
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 11 Sep 2026to 11 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- Inability to walk or perform unsupervised exercises.
- Vulnerable people
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Frédéric Chorin contact
About this study
Official title: 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.
Read more
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.
- Conditions
- Geriatric Oncology
- Being tested
- Personalized pre-habilitation program
- Keywords
- ederly, cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized pre-habilitation programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Personalized pre-habilitation program | Experimental | Not described Receives: Other: Personalized pre-habilitation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal walking distance to 6 -MWT
Metres walked during 6 minutes
Measured: at inclusion
Maximal walking distance to 6 -MWT
Metres walked during the test
Measured: at 4 weeks
Maximal walking distance to 6 -MWT
Metres walked during the test
Measured: at 8 weeks
Maximal walking distance to 6 -MWT
Metres walked during the test
Measured: at 16 weeks
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: at inclusion, 4 weeks, 8 weeks, 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2024
- Study start11 Sep 2026
- Primary completion11 May 2028 (estimated)
- Study completion11 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Geriatric OncologyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Implementation of a personalized pre-habilitation program at home before surgery
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rabia Boulahssass, MD, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06443138
- Sponsor's protocol ID
- 23-AOIP-03
- Acronym
- PRIMECHO
- Status last verified
- Sep 2026
- First submitted
- 23 May 2024
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preparation for Medical and Surgical Procedures in Oncogeriatry. Pilote Study PRIMECHO
- ClinicalTrials.gov ID
- NCT06443138
- Acronym / sponsor ID
- PRIMECHO / 23-AOIP-03
- Conditions
- Geriatric Oncology
- Keywords
- ederly, cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 11 Sep 2026 (actual)
- Primary completion
- 11 May 2028 (estimated)
- Study completion
- 11 Sep 2028 (estimated)
- First posted
- 5 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Implementation of a personalized pre-habilitation program at home before surgery
| Arm | Type | Receives |
|---|---|---|
| Personalized pre-habilitation program | Experimental | Other: Personalized pre-habilitation program |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Inability to walk or perform unsupervised exercises.
- Vulnerable people
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalized pre-habilitation programEach 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. | Other | Personalized pre-habilitation program |
Primary outcome
Maximal walking distance to 6 -MWT
Time frame: at inclusion
Metres walked during 6 minutes
Maximal walking distance to 6 -MWT
Time frame: at 4 weeks
Metres walked during the test
Maximal walking distance to 6 -MWT
Time frame: at 8 weeks
Metres walked during the test
Maximal walking distance to 6 -MWT
Time frame: at 16 weeks
Metres walked during the test
3 secondary outcomes
EORTC-QLQC30
Time frame: at inclusion, 4 weeks, 8 weeks, 16 weeks
Fatigue scale (MFI-20)
Time frame: at inclusion, 4 weeks, 8 weeks, 16 weeks
Internationnal Physiqual activity questionaire (IPAQ-short)
Time frame: at inclusion, 4 weeks, 8 weeks, 16 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Frédéric Chorin contact
Rabia Boulahssass, MD principal investigator
Centre Hospitalier Universitaire de Nice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized pre-habilitation program in people with Geriatric Oncology, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rabia Boulahssass, MD (04 92 03 41 94, boulahssass.r@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal walking distance to 6 -MWT (time frame: at inclusion). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.