Aged Patients Treated for Cancer in OutclinicsCHUPACHOUPNCT06504628
Falls Among the Older Patients Treated for Cancer in Normandy's Outclinics: Screening and Prevention
An observational study of Aged Patients Treated for Cancer in Outclinics, run by University Hospital, Caen at 10 sites in France.
Trial summary
The French Plan National AntiChute (published on February 21, 2022) and international recommendations on falls prevention (Age Ageing,September 2022) recommend identifying the risk of falling in people aged 65 and over, at least once a year during a follow-up consultation. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Aged Patients Treated for Cancer in Outclinics
- What is being tested?
- screening risk for falling and identifiy the risk level low-intermediate-high and 3 mnth-follow-up
- How many people
- 328 participants
- Where
- 10 sitesFrance
- Study dates
- 16 Sep 2024to 15 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients aged 65 and over treated for cancer or haematological malignancy in public and private outclinics -hospitals in Normandy
Who may be able to join
- aged 65 or over
- undergoing treatment for cancer or hematological malignancy (oral or injectable systemic treatment, radiotherapy)
- covered by health insurance
- having read the information document and no objection
- French-speaking
- Autonomous ( with occasional assistance with instrumental daily activities),
Who cannot join
- refusal to participate
- unable to communicate
- dependent (requiring geriatric care)
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites
Centre de radiothérapie de la Baie
Avranches
Caen UH
Caen, Normandy, 14000
Centre de radiothérapie Maurice Tubiana/Polyclinique Parc
Caen
CLCC François Baclesse
Caen
Centre Hospitalier Public du Cotentin
Cherbourg
Centre Hospitalier Evreux-VErnon
Évreux
Hôpital Privé de l Estuaire
Le Havre
Centre Hospitalier Robert Bisson
Lisieux
Becquerel Cancer CEnter
Rouen, 76000
CHU de Rouen Charles Nicolle
Rouen
About this study
Official title: CHUtes Chez Les Personnes Agées traitées Pour Cancer Dans Les HOpitaUx Normands : repérage et Prévention
The French Plan National AntiChute (published on February 21, 2022) and international recommendations on falls prevention (Age Ageing,September 2022) recommend identifying the risk of falling in people aged 65 and over, at least once a year during a follow-up consultation. The presence of chronic illness such as cancer increases the risk for falling. Recommendations suggest targeted preventive interventions according to the risk level, and early reassessment at 3 months in case of high risk.
This study consists of a cross-sectional survey conducted during a week dedicated to patient safety (September 16-20, 2024), to identify the prevalence of patients at high risk for falling, requiring enhanced care. The relation between high risk for falling and social and oncological characteristics will be studied. A 3-month telephone follow-up will identify any obstacles to implementing the recommendations in this high-risk group.
This multicenter cross-sectional prospective study is exploratory.
- Being tested
- screening risk for falling and identifiy the risk level low-intermediate-high, 3 mnth-follow-up
- Keywords
- aged, outpatients, cancer, accidental falls
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
screening risk for falling and identifiy the risk level low-intermediate-highDiagnostic test
Also called prevention by handing over a leeflet listing recommendations to patients and general practitionners
3 key questions: Any posiitve answer to a) Has fallen in the past year? b) Feels unsteady when standing or walking? or c) Worries about falling? prompts to "fall severity" step.
if "no" at the three questions= low level of fall-risk Fall severity: fall with injuires, laying on the ground with no capacity to get up, or a visit to emergency room, or loss of conscienciousness/suspected syncope. or Frailty (Clinical Frailty Scale)= if positive, high risk otherwise, 4 meter-walk test: if =<0.8m/sec= intermediate risk if >0.8m/sec=intermediate risk
3 mnth-follow-upDiagnostic test
patient's phone call, and data collected from electronic medical record
| Study group | Role | What they receive |
|---|---|---|
| low risk for fall subgroup | according to Manuel Montero-Odasso M, Nathalie van der Velde, Finbarr C Martin, Mirko Petrovic, Maw Pin Tan, Jesper Ryg, et al. World guidelines for falls prevention and management for older adults: a global initiative. Age and Ageing, Volume 51, Issue 9, September 2022 Receives: Diagnostic Test: screening risk for falling and identifiy the risk level low-intermediate-high | |
| intermediate risk for fall subgroup | according to Manuel Montero-Odasso M, Nathalie van der Velde, Finbarr C Martin, Mirko Petrovic, Maw Pin Tan, Jesper Ryg, et al. World guidelines for falls prevention and management for older adults: a global initiative. Age and Ageing, Volume 51, Issue 9, September 2022 Receives: Diagnostic Test: screening risk for falling and identifiy the risk level low-intermediate-high | |
| high risk for fall subgroup | according to Manuel Montero-Odasso M, Nathalie van der Velde, Finbarr C Martin, Mirko Petrovic, Maw Pin Tan, Jesper Ryg, et al. World guidelines for falls prevention and management for older adults: a global initiative. Age and Ageing, Volume 51, Issue 9, September 2022.
Those patients will be contacted 3 mnths after inclusion for follow-up assessment Receives: Diagnostic Test: screening risk for falling and identifiy the risk level low-intermediate-high; Diagnostic Test: 3 mnth-follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of each of the three levels of fall-risk
describe the distribution of patients in mild, intermediate and high risk for falling
Measured: Day 1
Secondary outcomes (4)
look for association between high-risk categorization and rural place of residence, gender, age bracket (65-74 and 75 and over), investigating center, type of cancer (location).
Measured: Day 1
Describe the rate of high-risk patients who will have benefited from (full or partial) implementation of recommended interventions according to 3-month follow-up.
Measured: 3 mnths
among high-risk patients followed up at 3 months, look for an association between the absence ofimplementation of recommendations and social, medical characteristics and motive
Measured: 3 mnths
describe the Average number of STOPPFALL medications per patient. Rate of patients with at least one oncologydrug listed as a fall risk (CIPN), in the 3 fall risk categories
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start16 Sep 2024
- Primary completion16 Sep 2024
- Study completion15 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aged Patients Treated for Cancer in OutclinicsStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 328 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06504628
- Sponsor's protocol ID
- 2024-A00979-38
- Acronym
- CHUPACHOUP
- Status last verified
- Sep 2024
- First submitted
- 10 Jul 2024
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Levard R, Mesnilgrante O, Le Bon P, Evenden P, L'Orphelin JM, Lebaube S, Villemin M, Delarue E, Dumont A, Basti S, Hamon M, Kaluzinski L, Pottier L, Dumont D, Fournier E, Bernardin P, Calache T, Boudin G, Homokos H, Cherel A, Magnan C, Fournel F, Meurant A, Briant A, Beauplet B. Falls in older patients treated for cancer in French outpatient departments: screening and prevention-a prospective observational study. Support Care Cancer. 2026 Aug 17;34(9):861. doi: 10.1007/s00520-026-11108-9.
PubMed 42608484
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CHUtes Chez Les Personnes Agées traitées Pour Cancer Dans Les HOpitaUx Normands : repérage et Prévention
- ClinicalTrials.gov ID
- NCT06504628
- Acronym / sponsor ID
- CHUPACHOUP / 2024-A00979-38
- Keywords
- aged, outpatients, cancer, accidental falls
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 328 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 16 Sep 2024 (actual)
- Primary completion
- 16 Sep 2024 (actual)
- Study completion
- 15 Feb 2025 (actual)
- First posted
- 17 Jul 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.
The French Plan National AntiChute (published on February 21, 2022) and international recommendations on falls prevention (Age Ageing,September 2022) recommend identifying the risk of falling in people aged 65 and over, at least once a year during a follow-up consultation. The presence of chronic illness such as cancer increases the risk for falling. Recommendations suggest targeted preventive interventions according to the risk level, and early reassessment at 3 months in case of high risk.
This study consists of a cross-sectional survey conducted during a week dedicated to patient safety (September 16-20, 2024), to identify the prevalence of patients at high risk for falling, requiring enhanced care. The relation between high risk for falling and social and oncological characteristics will be studied. A 3-month telephone follow-up will identify any obstacles to implementing the recommendations in this high-risk group.
This multicenter cross-sectional prospective study is exploratory.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| low risk for fall subgroup | – | Diagnostic Test: screening risk for falling and identifiy the risk level low-intermediate-highaccording to Manuel Montero-Odasso M, Nathalie van der Velde, Finbarr C Martin, Mirko Petrovic, Maw Pin Tan, Jesper Ryg, et al. World guidelines for falls prevention and management for older adults: a global initiative. Age and Ageing, Volume 51, Issue 9, September 2022 |
| intermediate risk for fall subgroup | – | Diagnostic Test: screening risk for falling and identifiy the risk level low-intermediate-highaccording to Manuel Montero-Odasso M, Nathalie van der Velde, Finbarr C Martin, Mirko Petrovic, Maw Pin Tan, Jesper Ryg, et al. World guidelines for falls prevention and management for older adults: a global initiative. Age and Ageing, Volume 51, Issue 9, September 2022 |
| high risk for fall subgroup | – | Diagnostic Test: screening risk for falling and identifiy the risk level low-intermediate-high, Diagnostic Test: 3 mnth-follow-upaccording to Manuel Montero-Odasso M, Nathalie van der Velde, Finbarr C Martin, Mirko Petrovic, Maw Pin Tan, Jesper Ryg, et al. World guidelines for falls prevention and management for older adults: a global initiative. Age and Ageing, Volume 51, Issue 9, September 2022. Those patients will be contacted 3 mnths after inclusion for follow-up assessment |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients aged 65 and over treated for cancer or haematological malignancy in public and private outclinics -hospitals in Normandy
Key inclusion criteria (6 listed)
- aged 65 or over
- undergoing treatment for cancer or hematological malignancy (oral or injectable systemic treatment, radiotherapy)
- covered by health insurance
- having read the information document and no objection
- French-speaking
Key exclusion criteria (3 listed)
- refusal to participate
- unable to communicate
- dependent (requiring geriatric care)
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 |
|---|---|---|
| screening risk for falling and identifiy the risk level low-intermediate-highAlso: prevention by handing over a leeflet listing recommendations to patients and general practitionners3 key questions: Any posiitve answer to a) Has fallen in the past year? b) Feels unsteady when standing or walking? or c) Worries about falling? prompts to "fall severity" step. if "no" at the three questions= low level of fall-risk Fall severity: fall with injuires, laying on the ground with no capacity to get up, or a visit to emergency room, or loss of conscienciousness/suspected syncope. or Frailty (Clinical Frailty Scale)= if positive, high risk otherwise, 4 meter-walk test: if =<0.8m/sec= intermediate risk if >0.8m/sec=intermediate risk | Diagnostic test | high risk for fall subgroup, intermediate risk for fall subgroup, low risk for fall subgroup |
| 3 mnth-follow-uppatient's phone call, and data collected from electronic medical record | Diagnostic test | high risk for fall subgroup |
Primary outcome
prevalence of each of the three levels of fall-risk
Time frame: Day 1
describe the distribution of patients in mild, intermediate and high risk for falling
4 secondary outcomes
look for association between high-risk categorization and rural place of residence, gender, age bracket (65-74 and 75 and over), investigating center, type of cancer (location).
Time frame: Day 1
Describe the rate of high-risk patients who will have benefited from (full or partial) implementation of recommended interventions according to 3-month follow-up.
Time frame: 3 mnths
among high-risk patients followed up at 3 months, look for an association between the absence ofimplementation of recommendations and social, medical characteristics and motive
Time frame: 3 mnths
describe the Average number of STOPPFALL medications per patient. Rate of patients with at least one oncologydrug listed as a fall risk (CIPN), in the 3 fall risk categories
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- Derived from this study: PubMed 42608484Levard R, Mesnilgrante O, Le Bon P, Evenden P, L'Orphelin JM, Lebaube S, Villemin M, Delarue E, Dumont A, Basti S, Hamon M, Kaluzinski L, Pottier L, Dumont D, Fournier E, Bernardin P, Calache T, Boudin G, Homokos H, Cherel A, Magnan C, Fournel F, Meurant A, Briant A, Beauplet B. Falls in older patients treated for cancer in French outpatient departments: screening and prevention-a prospective observational study. Support Care Cancer. 2026 Aug 17;34(9):861. doi: 10.1007/s00520-026-11108-9.
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aged Patients Treated for Cancer in Outclinics, run by University Hospital, Caen at 10 sites 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 6 inclusion and 3 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: finished, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of each of the three levels of fall-risk (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06504628, which also lists 1 linked publication.
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 25 Mar 2025; AzTrials last refreshed its copy on 7 Nov 2026.