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Completed

NCT Number: NCT06504628

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

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.

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Key information

Conditions

Aged Patients Treated for Cancer in Outclinics Neoplasms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Caen UH, Caen, Normandy, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

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

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

3 mnth-follow-up

Diagnostic Test

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Registry information

Official study title

CHUtes Chez Les Personnes Agées traitées Pour Cancer Dans Les HOpitaUx Normands : repérage et Prévention

Acronym: CHUPACHOUP

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Jul 17, 2024
Registry last updated
Mar 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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