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

August 25, 2016 updated by: Assistance Publique - Hôpitaux de Paris

Assessing the Evolution and Determinants of Quality of Life in Elderly Cancer Patients and Their Caregivers: a Prospective Multicenter Observational Cohort Study.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Créteil, France, 94010
      • Nancy, France, 54000
        • Recruiting
        • CHRU NANCY
        • Contact:
      • Paris, France, 75010

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
At baseline, 3, 6, and 12 months
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
At baseline, 3, 6, and 12 months
Changes in HRQoL of patients as assessed by the specific EORTC-QLQ C30 questionnaire
Time Frame: At baseline, 3, 6, and 12 months
At baseline, 3, 6, and 12 months
Changes in HRQoL of patients as assessed by the specific EORTC QLQ-ELD14 questionnaire
Time Frame: At baseline, 3, 6, and 12 months
At baseline, 3, 6, and 12 months
Changes in burden of patients' caregivers as assessed by the Zarit burden inventory questionnaire
Time Frame: At baseline, 3, 6, and 12 months
At baseline, 3, 6, and 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Psychometric properties of the HRQoL questionnaire WHOQOL-OLD (validity, reliability, sensitivity to change, feasibility)
Time Frame: At baseline, 3, 6, and 12 months
At baseline, 3, 6, and 12 months
Psychometric properties of the HRQoL questionnaire EORTC QLQ-ELD14 (validity, reliability, sensitivity to change, feasibility)
Time Frame: At baseline, 3, 6, and 12 months
At baseline, 3, 6, and 12 months
Prognostic value of baseline HRQoL measurements on cancer progression-free survival
Time Frame: At baseline, 3, 6, and 12 months
At baseline, 3, 6, and 12 months
Prognostic value of baseline HRQoL measurements on overall survival
Time Frame: At baseline, 3, 6, and 12 months
At baseline, 3, 6, and 12 months
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
At baseline, 3, 6, and 12 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assistance Publique - Hôpitaux de Paris

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Institut de Cancérologie de Lorraine
Ligue contre le cancer, France
Quality of life and cancer clinical research platform
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
Unité de Coordination en Onco-Gériatrie (UCOG) Sud Val-de-Marne
Conseil Régional de Lorraine, France

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Christine Perret-Guillaume, CHU de Nancy
  • Study Chair: Elena Paillaud, Hôpital Albert Chenevier

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 14, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 3, 2016

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 26, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 25, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2014-A00317-40

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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