Clinical trial NCT03343210: Quality of Life and Cancers in Nursing Homes
Official title: Quality of Life and Cancers in Nursing Homes
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Quality of Life
Cancer
Nurse's Role
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2017-11-17
Enrollment: 73
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: quality of life measurement in patients
timeFrame: day 1
Secondary outcomes:
measure: pain level
timeFrame: day 1
measure: independance loss
timeFrame: day 1
measure: frequency of dementia
timeFrame: 3 months
Other outcomes:
Locations:
city: Amiens
country: France
facility: Amiens UH
city: Caen
country: France
facility: Caen UH
city: Cherbourg
country: France
facility: Pasteur HC
city: Fécamp
country: France
facility: Fecamp HC
city: Rouen
country: France
facility: Rouen UH
city: Saint-Quentin
country: France
facility: Saint Quentin HC
Study officials:
References:
citation: 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.
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. French.
citation: 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.
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 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.