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

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.

Study Overview

• Status: Completed
• Conditions: Aged Patients Treated for Cancer in Outclinics
• Intervention / Treatment: Diagnostic test: screening risk for falling and identifiy the risk level low-intermediate-high; Diagnostic test: 3 mnth-follow-up

• Study Type: Observational
• Enrollment (Actual): 328

Contacts and Locations

Study Locations

• France
  • Avranches, France
    • Centre de radiothérapie de la Baie
  • Caen, France
    • Centre de radiothérapie Maurice Tubiana/Polyclinique Parc
  • Caen, France
    • CLCC François BACLESSE
  • Cherbourg, France
    • Centre Hospitalier Public du Cotentin
  • Le Havre, France
    • Hopital Prive de L Estuaire
  • Lisieux, France
    • Centre Hospitalier Robert Bisson
  • Rouen, France, 76000
    • Becquerel Cancer CEnter
  • Rouen, France
    • CHU de Rouen Charles Nicolle
  • Évreux, France
    • Centre Hospitalier Evreux-VErnon
  • Normandie
    • Caen, Normandie, France, 14000
      • Caen UH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Diagnostic test: 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; Other Names: prevention by handing over a leeflet listing recommendations to patients and general practitionners
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	Diagnostic test: 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; Other Names: prevention by handing over a leeflet listing recommendations to patients and general practitionners
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	Diagnostic test: 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; Other Names: prevention by handing over a leeflet listing recommendations to patients and general practitionners; Diagnostic test: 3 mnth-follow-up; patient's phone call, and data collected from electronic medical record

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
prevalence of each of the three levels of fall-risk	describe the distribution of patients in mild, intermediate and high risk for falling	Day 1

Secondary Outcome Measures

Outcome Measure	Time Frame
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).	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.	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	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	Day 1

Collaborators and Investigators

• Sponsor: University Hospital, Caen

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2024
• Primary Completion (Actual): September 16, 2024
• Study Completion (Actual): February 15, 2025

Study Registration Dates

• First Submitted: July 10, 2024
• First Submitted That Met QC Criteria: July 10, 2024
• First Posted (Actual): July 17, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 24, 2025
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: cancer; accidental falls; aged; outpatients
• Other Study ID Numbers: 2024-A00979-38

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No