QUALICE: Quality of Life and Cancers in Nursing Homes

Sponsor
University Hospital, Caen (Other)
Overall Status
Terminated
CT.gov ID
NCT03343210
Collaborator
(none)
73
Enrollment
6
Locations
2
Arms
23.7
Actual Duration (Months)
12.2
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Diagnostic Test: quality of life and pain measurement .
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
73 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Quality of Life and Cancers in Nursing Homes
Actual Study Start Date :
Jul 18, 2018
Actual Primary Completion Date :
Aug 16, 2018
Actual Study Completion Date :
Jul 9, 2020

Arms and Interventions

ArmIntervention/Treatment
Experimental: cancer patient

cancer patient

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

Active Comparator: no cancer patient

no cancer patient

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

Outcome Measures

Primary Outcome Measures

  1. quality of life measurement in patients [day 1]

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

Secondary Outcome Measures

  1. pain level [day 1]

    Simple Verbal Scale or Doloplus scale

  2. independance loss [day 1]

    AGGIR(Autonomie Gérontologique et Groupes Iso-Ressources) scale

  3. frequency of dementia [3 months]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
70 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Amiens UHAmiensFrance
2Caen UHCaenFrance
3Pasteur HCCherbourgFrance
4Fecamp HCFécampFrance
5Rouen UHRouenFrance
6Saint Quentin HCSaint-QuentinFrance

Sponsors and Collaborators

  • University Hospital, Caen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Caen
ClinicalTrials.gov Identifier:
NCT03343210
Other Study ID Numbers:
  • QUALICE 16-180
First Posted:
Nov 17, 2017
Last Update Posted:
Oct 7, 2021
Last Verified:
Jan 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Oct 7, 2021