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Determinants of Quality Of Life in AGEd Cancer Patients (DEQOLAGE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02672657
Recruitment Status : Unknown
Verified August 2016 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was:  Recruiting
First Posted : February 3, 2016
Last Update Posted : August 26, 2016
Sponsor:
Collaborators:
Research Team CEpiA (Clinical Epidemiology and Ageing) EA7376, University Paris Est Créteil (UPEC)
Research Team APEMAC EA4360, University of Lorraine
Unité de Recherche Clinique Mondor, Hôpital Henri Mondor
Institut de Cancérologie de Lorraine
Unité de Coordination en Onco-Gériatrie (UCOG) Sud Val-de-Marne
Quality of life and cancer clinical research platform
Ligue contre le cancer, France
Conseil Régional de Lorraine, France
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:

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.


Condition or disease
Colorectal Neoplasms Prostatic Neoplasms

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessing the Evolution and Determinants of Quality of Life in Elderly Cancer Patients and Their Caregivers: a Prospective Multicenter Observational Cohort Study.
Study Start Date : February 2016
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers




Primary Outcome Measures :
  1. Changes in HRQoL of patients and their caregivers as assessed by the generic WHOQOL-BREF questionnaires [ Time Frame: At baseline, 3, 6, and 12 months ]
  2. Changes in HRQoL of patients and their caregivers if aged >70 years as assessed by the WHOQOL-OLD questionnaire [ Time Frame: At baseline, 3, 6, and 12 months ]
  3. Changes in HRQoL of patients as assessed by the specific EORTC-QLQ C30 questionnaire [ Time Frame: At baseline, 3, 6, and 12 months ]
  4. Changes in HRQoL of patients as assessed by the specific EORTC QLQ-ELD14 questionnaire [ Time Frame: At baseline, 3, 6, and 12 months ]
  5. Changes in burden of patients' caregivers as assessed by the Zarit burden inventory questionnaire [ Time Frame: At baseline, 3, 6, and 12 months ]

Secondary Outcome Measures :
  1. Psychometric properties of the HRQoL questionnaire WHOQOL-OLD (validity, reliability, sensitivity to change, feasibility) [ Time Frame: At baseline, 3, 6, and 12 months ]
  2. Psychometric properties of the HRQoL questionnaire EORTC QLQ-ELD14 (validity, reliability, sensitivity to change, feasibility) [ Time Frame: At baseline, 3, 6, and 12 months ]
  3. Prognostic value of baseline HRQoL measurements on cancer progression-free survival [ Time Frame: At baseline, 3, 6, and 12 months ]
  4. Prognostic value of baseline HRQoL measurements on overall survival [ Time Frame: At baseline, 3, 6, and 12 months ]
  5. Prognostic value of baseline HRQoL measurements on patient's functional decline, defined as any decrease in the ADL scale [ Time Frame: At baseline, 3, 6, and 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients presenting at the participating hospitals with newly diagnosed colorectal or prostate cancer and referred by an oncologist, surgeon, radiotherapist, or other specialist to the hospital geriatric oncology clinics for a multidimensional geriatric assessment before the initiation of cancer treatment will be eligible for inclusion, regardless of stage at diagnosis and plans for treatment
Criteria

Patients

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

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

Caregivers Inclusion criteria

  • 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

- Physical, cognitive or linguistic incapacity to complete questionnaires


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): NCT02672657


Contacts
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Contact: Etienne Audureau, Md, PhD (0)1 49 81 36 64 ext +33 etienne.audureau@aphp.fr

Locations
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France
Hôpital Henri Mondor Recruiting
Créteil, France, 94010
Contact: Philippe Caillet    (0)1 49 81 24 86 ext +33    philippe.caillet@hmn.aphp.fr   
CHRU Nancy Recruiting
Nancy, France, 54000
Contact: Jean Yves Niemier    (0)3 83 15 32 20 ext +33    jy.niemier@chu-nancy.fr   
Hôpital Saint Louis Recruiting
Paris, France, 75010
Contact: Pierre Mongiat-Artus    (0)1 42 49 96 23 ext +33    pierre.mongiat-artus@sls.aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Research Team CEpiA (Clinical Epidemiology and Ageing) EA7376, University Paris Est Créteil (UPEC)
Research Team APEMAC EA4360, University of Lorraine
Unité de Recherche Clinique Mondor, Hôpital Henri Mondor
Institut de Cancérologie de Lorraine
Unité de Coordination en Onco-Gériatrie (UCOG) Sud Val-de-Marne
Quality of life and cancer clinical research platform
Ligue contre le cancer, France
Conseil Régional de Lorraine, France
Investigators
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Study Chair: Christine Perret-Guillaume CHU de Nancy
Study Chair: Elena Paillaud Hôpital Albert Chenevier
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02672657    
Other Study ID Numbers: 2014-A00317-40
First Posted: February 3, 2016    Key Record Dates
Last Update Posted: August 26, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Health-Related Quality of life
Cancer
Elderly
Caregivers
Additional relevant MeSH terms:
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Colorectal Neoplasms
Prostatic Neoplasms
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Diseases