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NCT03343210 Clinical Trial

Quality of Life and Cancers in Nursing Homes

Cancer Clinical Trial

— QUALICE  

Official title:
Quality of Life and Cancers in Nursing Homes

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT03343210
Other study ID # QUALICE 16-180
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date July 18, 2018
Est. completion date July 9, 2020

Study information
Verified date January 2020
Source University Hospital, Caen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Description:

Investigators will also make a descriptive inventory of the oncological care and support care in these patients, in order to evaluate the need for a specific oncogeriatric intervention. Quality of life and pain will be compared with a randomized residents control group, in each hospital.

Recruitment information / eligibility
Status Terminated
Enrollment 73
Est. completion date July 9, 2020
Est. primary completion date August 16, 2018
Accepts healthy volunteers No
Gender All
Age group 70 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - Severe dementia (MMS <10/30) • Total disability to communicate

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• quality of life and pain measurement .
comparison of quality of life measurement in residents with cancer and in cancer-free residents, by a geriatric consultations'nurse

Locations
Country Name City State
France Amiens UH Amiens
France Caen UH Caen
France Pasteur HC Cherbourg
France Fecamp HC Fécamp
France Rouen UH Rouen
France Saint Quentin HC Saint-Quentin

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

References & 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. Review. — View Citation

Leplège A, Perret-Guillaume C, Ecosse E, Hervy MP, Ankri J, von Steinbüchel 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. E — View Citation

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. Review. French. — View Citation

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 — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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 pain level Simple Verbal Scale or Doloplus scale day 1
Secondary independance loss AGGIR(Autonomie Gérontologique et Groupes Iso-Ressources) scale day 1
Secondary frequency of dementia in ordrer to Prepare a interventionnal care study for residents with cancer: Describing cancers management in nursing homes without any oncogeriatrician, Refining the expected effect of an oncogeriatry intervention on QOL (margin of improvement relative to the cancer free population) Estimating the intraclass correlation coefficient of QOL, Compare quality of life scores among seniors with no cognitive impairment 3 months
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