Quality of Life and Cancers in Nursing Homes (QUALICE)

September 29, 2021 updated by: University Hospital, Caen

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

73

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France
        • Amiens UH
      • Caen, France
        • Caen UH
      • Cherbourg, France
        • Pasteur HC
      • Fécamp, France
        • Fecamp HC
      • Rouen, France
        • Rouen UH
      • Saint-Quentin, France
        • Saint Quentin HC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
quality of life measurement in patients
Time Frame: day 1
Logsdon Quality Of Life Alzheimer Dementia scale if neurodegenerative disease or WHO-Quality Of Life- OLD scale if none
day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain level
Time Frame: day 1
Simple Verbal Scale or Doloplus scale
day 1
independance loss
Time Frame: day 1
AGGIR(Autonomie Gérontologique et Groupes Iso-Ressources) scale
day 1
frequency of dementia
Time Frame: 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
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Caen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 18, 2018

Primary Completion (ACTUAL)

August 16, 2018

Study Completion (ACTUAL)

July 9, 2020

Study Registration Dates

First Submitted

March 7, 2017

First Submitted That Met QC Criteria

November 9, 2017

First Posted (ACTUAL)

November 17, 2017

Study Record Updates

Last Update Posted (ACTUAL)

October 7, 2021

Last Update Submitted That Met QC Criteria

September 29, 2021

Last Verified

January 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • QUALICE 16-180

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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