Falls Among the Older Patients Treated for Cancer in Normandy's Outclinics: Screening and Prevention

NCT ID: NCT06504628

Last Updated: 2025-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

328 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-09-16

Study Completion Date

2025-02-15

Brief Summary

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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.

Detailed Description

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Conditions

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Aged Patients Treated for Cancer in Outclinics

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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

screening risk for falling and identifiy the risk level low-intermediate-high

Intervention Type DIAGNOSTIC_TEST

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

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

screening risk for falling and identifiy the risk level low-intermediate-high

Intervention Type DIAGNOSTIC_TEST

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

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

screening risk for falling and identifiy the risk level low-intermediate-high

Intervention Type DIAGNOSTIC_TEST

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-up

Intervention Type DIAGNOSTIC_TEST

patient's phone call, and data collected from electronic medical record

Interventions

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screening risk for falling and identifiy the risk level low-intermediate-high

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

Intervention Type DIAGNOSTIC_TEST

3 mnth-follow-up

patient's phone call, and data collected from electronic medical record

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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prevention by handing over a leeflet listing recommendations to patients and general practitionners

Eligibility Criteria

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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)
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Caen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Caen UH

Caen, Normandy, France

Site Status

Centre de radiothérapie de la Baie

Avranches, , France

Site Status

Centre de radiothérapie Maurice Tubiana/Polyclinique Parc

Caen, , France

Site Status

CLCC François Baclesse

Caen, , France

Site Status

Centre Hospitalier Public du Cotentin

Cherbourg, , France

Site Status

Centre Hospitalier Evreux-VErnon

Évreux, , France

Site Status

Hôpital Privé de l Estuaire

Le Havre, , France

Site Status

Centre Hospitalier Robert Bisson

Lisieux, , France

Site Status

Becquerel Cancer CEnter

Rouen, , France

Site Status

CHU de Rouen Charles Nicolle

Rouen, , France

Site Status

Countries

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France

Other Identifiers

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2024-A00979-38

Identifier Type: -

Identifier Source: org_study_id

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