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Trial record 7 of 261 for:    Not yet recruiting Studies | Quality of Life

Quality of Life and Cancers in Nursing Homes (QUALICE)

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ClinicalTrials.gov Identifier: NCT03343210
Recruitment Status : Not yet recruiting
First Posted : November 17, 2017
Last Update Posted : November 30, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Caen

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 disease Intervention/treatment Phase
Quality of Life Cancer Nurse's Role Diagnostic Test: quality of life and pain measurement . Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 176 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
Estimated Study Start Date : December 1, 2017
Estimated Primary Completion Date : February 1, 2018
Estimated Study Completion Date : May 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Nursing Homes

Arm Intervention/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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. pain [ Time Frame: day 1 ]
    Simple Verbal Scale or Doloplus scale

  2. independance loss [ Time Frame: day 1 ]
    AGGIR(Autonomie Gérontologique et Groupes Iso-Ressources) scale

  3. 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



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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03343210


Contacts
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Contact: berengere beauplet, PhD +33231065344 beauplet-b@chu-caen.fr
Contact: cathy gaillard +33231065349 gaillard-c@chu-caen.fr

Sponsors and Collaborators
University Hospital, Caen

Publications of Results:
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Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT03343210     History of Changes
Other Study ID Numbers: QUALICE 16-180
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: November 30, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No