Determinants of Quality Of Life in AGEd Cancer Patients

NCT ID: NCT02672657

Last Updated: 2016-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-02-29

Study Completion Date

2019-12-31

Brief Summary

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Patients face multiple stresses and challenges in the aftermath of cancer diagnosis. Despite needs perceived by elderly patients might differ from those of younger patients, there is a paucity of published data assessing the specific evolution and relevant determinants of health-related quality of life (HRQoL) in older patients with cancer. Such determinants may include cancer type/location/stage, treatment type/intensity, comorbidities, nutritional status or socioeconomic features, but also practical organization of care -frequency, geographical distance, supporting measures -, or psychosocial and material support - social network, housing conditions and contextual neighborhood features. Comparatively to dementia or cancer in younger patients, little is known in the oncogeriatric field of the impact on caregivers' perceived burden and HRQol of the support they provide to patients. Further, the potential interactions between patients' and caregivers' HRQoL remain largely unknown, while caregivers are often themselves old with chronic diseases and/or daily living activities' limitations.

The DEQOLAGE study is a prospective observational cohort study that aims to describe the HRQoL of patients aged over 70 years with a colorectal or prostatic cancer during the first year following the diagnosis of the disease as well as the HRQoL and burden in their main caregivers. This study will allow a comprehensive assessment of multiple determinants of HRQoL operating at different levels, including individual (cancer type/location/stage, treatment type/intensity, comorbidities, nutritional status or socioeconomic features), contextual (social network, housing conditions and contextual neighborhood features) and organizational factors (frequency, geographical distance, supporting measures). We also hypothesize that complex interactions may operate between patient's and caregiver's HRQoL and perceived burden. Quality of life measurement will be based on two recent scales specifically designed for the elderly to confirm their psychometric properties and in-field feasibility.

Detailed Description

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Conditions

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Colorectal Neoplasms Prostatic Neoplasms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Aged 70 or more
* With a new histologically confirmed diagnosis of colorectal or prostate cancer
* With a Comprehensive Geriatric Assessment (CGA) performed before the initiation of cancer treatment
* Having expressed their oral non-opposition to participate in the study
* Affiliated to a health insurance scheme


* Aged 18 or more
* Nonprofessionally, partially or fully helping the patient in daily activities and accompanying the patient to visits; familial ties with the patient are not required (spouse, child, friend or neighbor)
* In contact with the patient more than once a week
* Defined by the patient during the inclusion visit as the main caregiver

Exclusion Criteria

* Expected survival inferior to 6 months, based on the clinical appreciation from the physician in charge of the enrollment
* Cancer recurrence in patients previously treated
* Physical, cognitive or linguistic incapacity to complete questionnaires


\- Physical, cognitive or linguistic incapacity to complete questionnaires
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Paris 12 Val de Marne University

OTHER

Sponsor Role collaborator

Research Team APEMAC EA4360, University of Lorraine

UNKNOWN

Sponsor Role collaborator

Unité de Recherche Clinique Mondor, Hôpital Henri Mondor

UNKNOWN

Sponsor Role collaborator

Institut de Cancérologie de Lorraine

OTHER

Sponsor Role collaborator

Unité de Coordination en Onco-Gériatrie (UCOG) Sud Val-de-Marne

UNKNOWN

Sponsor Role collaborator

Quality of life and cancer clinical research platform

UNKNOWN

Sponsor Role collaborator

Ligue contre le cancer, France

OTHER

Sponsor Role collaborator

Conseil Régional de Lorraine, France

UNKNOWN

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christine Perret-Guillaume

Role: STUDY_CHAIR

Central Hospital, Nancy, France

Elena Paillaud

Role: STUDY_CHAIR

Hôpital Albert Chenevier

Locations

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Hôpital Henri Mondor

Créteil, , France

Site Status RECRUITING

CHRU Nancy

Nancy, , France

Site Status RECRUITING

Hôpital Saint Louis

Paris, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Etienne Audureau, Md, PhD

Role: CONTACT

(0)1 49 81 36 64 ext. +33

Facility Contacts

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Philippe Caillet

Role: primary

(0)1 49 81 24 86 ext. +33

Jean Yves Niemier

Role: primary

(0)3 83 15 32 20 ext. +33

Pierre Mongiat-Artus

Role: primary

(0)1 42 49 96 23 ext. +33

Other Identifiers

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2014-A00317-40

Identifier Type: -

Identifier Source: org_study_id

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