Clinical trial NCT06504628: Falls Among the Older Patients Treated for Cancer in Normandy's Outclinics: Screening and Prevention
Official title: CHUtes Chez Les Personnes Agées traitées Pour Cancer Dans Les HOpitaUx Normands : repérage et Prévention
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aged Patients Treated for Cancer in Outclinics
Keywords: aged
outpatients
cancer
accidental falls
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2024-07-17
Enrollment: 328
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 65 and over treated for cancer or haematological malignancy in public and private outclinics -hospitals in Normandy

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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),

Exclusion Criteria:

* refusal to participate
* unable to communicate
* dependent (requiring geriatric care)

Primary outcomes:
measure: prevalence of each of the three levels of fall-risk
timeFrame: Day 1
Secondary outcomes:
measure: 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).
timeFrame: Day 1
measure: 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.
timeFrame: 3 mnths
measure: 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
timeFrame: 3 mnths
measure: 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
timeFrame: Day 1
Other outcomes:
Locations:
city: Caen
country: France
facility: Caen UH
state: Normandie
city: Avranches
country: France
facility: Centre de radiothérapie de la Baie
city: Caen
country: France
facility: Centre de radiothérapie Maurice Tubiana/Polyclinique Parc
city: Caen
country: France
facility: CLCC François Baclesse
city: Cherbourg
country: France
facility: Centre Hospitalier Public du Cotentin
city: Le Havre
country: France
facility: Hôpital Privé de l Estuaire
city: Lisieux
country: France
facility: Centre Hospitalier Robert Bisson
city: Rouen
country: France
facility: Becquerel Cancer CEnter
city: Rouen
country: France
facility: CHU de Rouen Charles Nicolle
city: Évreux
country: France
facility: Centre Hospitalier Evreux-VErnon
Study officials:
References: