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

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

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 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

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

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

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

Assistance Publique - Hôpitaux de Paris

Collaborators

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

  • Study Chair: Christine Perret-Guillaume, Chu de Nancy
  • Study Chair: Elena Paillaud, Hopital 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

February 1, 2016

Primary Completion (Anticipated)

February 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

January 14, 2016

First Submitted That Met QC Criteria

January 29, 2016

First Posted (Estimate)

February 3, 2016

Study Record Updates

Last Update Posted (Estimate)

August 26, 2016

Last Update Submitted That Met QC Criteria

August 25, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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