NCT03343210

Brief Summary

Quality of life (QOL) of nursing homes residents with cancer in France is not known. High prevalence of neurodegenerative diseases makes it difficult. It was found that oncological management is suboptimal among Poitevin territory residents. Publications report an inadequate management of symptoms of discomfort related to cancers. The multicentric study will comparate quality of life in patients with and without Cancers in nursing homes, including residents with neurodegenerative disease, using validated questionnaires. These questionnaires, as well as pain evaluation, will be carried out by a geriatric consultations' nurse.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P50-P75 for not_applicable quality-of-life

Timeline
Completed

Started Jul 2018

Typical duration for not_applicable quality-of-life

Geographic Reach
1 country

6 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 7, 2017

Completed
9 months until next milestone

First Posted

Study publicly available on registry

November 17, 2017

Completed
8 months until next milestone

Study Start

First participant enrolled

July 18, 2018

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 16, 2018

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 9, 2020

Completed
Last Updated

October 7, 2021

Status Verified

January 1, 2020

Enrollment Period

29 days

First QC Date

March 7, 2017

Last Update Submit

September 29, 2021

Conditions

Quality of LifeCancerNurse's Role

Outcome Measures

Primary Outcomes (1)

  • quality of life measurement in patients

    Logsdon Quality Of Life Alzheimer Dementia scale if neurodegenerative disease or WHO-Quality Of Life- OLD scale if none

    day 1

Secondary Outcomes (3)

  • pain level

    day 1

  • independance loss

    day 1

  • frequency of dementia

    3 months

Study Arms (2)

cancer patient

EXPERIMENTAL

cancer patient

Diagnostic Test: quality of life and pain measurement .

no cancer patient

ACTIVE COMPARATOR

no cancer patient

Diagnostic Test: quality of life and pain measurement .

Interventions

quality of life and pain measurement .DIAGNOSTIC_TEST

comparison of quality of life measurement in residents with cancer and in cancer-free residents, by a geriatric consultations'nurse

cancer patientno cancer patient

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Affiliated to the social security system
  • talking french language
  • Cancer group: All residents with a history of cancer,
  • Control group: residents without any history of cancer (same number of residents as in the cancer group), randomly selected in each nursing home, matched to age, sex, presence of dementia (mild or Moderate), and AGGIR dependancy scale

You may not qualify if:

  • Severe dementia (MMS \<10/30) • Total disability to communicate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Amiens UH

Amiens, France

Location

Caen UH

Caen, France

Location

Pasteur HC

Cherbourg, France

Location

Fecamp HC

Fécamp, France

Location

Rouen UH

Rouen, France

Location

Saint Quentin HC

Saint-Quentin, France

Location

Related Publications (4)

  • Drageset J, Corbett A, Selbaek G, Husebo BS. Cancer-related pain and symptoms among nursing home residents: a systematic review. J Pain Symptom Manage. 2014 Oct;48(4):699-710.e1. doi: 10.1016/j.jpainsymman.2013.12.238. Epub 2014 Apr 3.

    PMID: 24703946RESULT

  • Novella JL, Dhaussy G, Wolak A, Morrone I, Drame M, Blanchard F, Jolly D. [Quality of life in dementia: state of the knowledge]. Geriatr Psychol Neuropsychiatr Vieil. 2012 Dec;10(4):365-72. doi: 10.1684/pnv.2012.0375. French.

    PMID: 23250016RESULT

  • Leplege A, Perret-Guillaume C, Ecosse E, Hervy MP, Ankri J, von Steinbuchel N. [A new instrument to measure quality of life in older people: The French version of the WHOQOL-OLD]. Rev Med Interne. 2013 Feb;34(2):78-84. doi: 10.1016/j.revmed.2012.07.011. Epub 2012 Dec 23. French.

    PMID: 23266010RESULT

  • Wheelwright S, Darlington AS, Fitzsimmons D, Fayers P, Arraras JI, Bonnetain F, Brain E, Bredart A, Chie WC, Giesinger J, Hammerlid E, O'Connor SJ, Oerlemans S, Pallis A, Reed M, Singhal N, Vassiliou V, Young T, Johnson C. International validation of the EORTC QLQ-ELD14 questionnaire for assessment of health-related quality of life elderly patients with cancer. Br J Cancer. 2013 Aug 20;109(4):852-8. doi: 10.1038/bjc.2013.407. Epub 2013 Jul 18.

    PMID: 23868003RESULT

MeSH Terms

Conditions

Neoplasms

Interventions

Pain Measurement

Intervention Hierarchy (Ancestors)

Neurologic ExaminationPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2017

First Posted

November 17, 2017

Study Start

July 18, 2018

Primary Completion

August 16, 2018

Study Completion

July 9, 2020

Last Updated

October 7, 2021

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(6)