Colorectal Neoplasms Clinical Trial
— DEQOLAGEOfficial title:
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.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | December 2019 |
Est. primary completion date | February 2019 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 70 Years and older |
Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
France | Hôpital Henri Mondor | Créteil | |
France | CHRU Nancy | Nancy | |
France | Hôpital Saint Louis | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris | Conseil Régional de Lorraine, France, Ligue contre le cancer, France, Quality of life and cancer clinical research platform, Research Team APEMAC EA4360, University of Lorraine, Research Team CEpiA (Clinical Epidemiology and Ageing) EA7376, University Paris Est Créteil (UPEC), Unité de Coordination en Onco-Gériatrie (UCOG) Sud Val-de-Marne, Unité de Recherche Clinique Mondor, Hôpital Henri Mondor, Unité Lorraine de Coordination en Oncogériatrie (ULCOG) - Institut de Cancérologie de Lorraine |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in HRQoL of patients and their caregivers as assessed by the generic WHOQOL-BREF questionnaires | At baseline, 3, 6, and 12 months | No | |
Primary | Changes in HRQoL of patients and their caregivers if aged >70 years as assessed by the WHOQOL-OLD questionnaire | At baseline, 3, 6, and 12 months | No | |
Primary | Changes in HRQoL of patients as assessed by the specific EORTC-QLQ C30 questionnaire | At baseline, 3, 6, and 12 months | No | |
Primary | Changes in HRQoL of patients as assessed by the specific EORTC QLQ-ELD14 questionnaire | At baseline, 3, 6, and 12 months | No | |
Primary | Changes in burden of patients' caregivers as assessed by the Zarit burden inventory questionnaire | At baseline, 3, 6, and 12 months | No | |
Secondary | Psychometric properties of the HRQoL questionnaire WHOQOL-OLD (validity, reliability, sensitivity to change, feasibility) | At baseline, 3, 6, and 12 months | No | |
Secondary | Psychometric properties of the HRQoL questionnaire EORTC QLQ-ELD14 (validity, reliability, sensitivity to change, feasibility) | At baseline, 3, 6, and 12 months | No | |
Secondary | Prognostic value of baseline HRQoL measurements on cancer progression-free survival | At baseline, 3, 6, and 12 months | No | |
Secondary | Prognostic value of baseline HRQoL measurements on overall survival | At baseline, 3, 6, and 12 months | No | |
Secondary | Prognostic value of baseline HRQoL measurements on patient's functional decline, defined as any decrease in the ADL scale | At baseline, 3, 6, and 12 months | No |
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