Determinants of Quality Of Life in AGEd Cancer Patients

Colorectal Neoplasms Clinical Trial

— DEQOLAGE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02672657
• Other study ID #: 2014-A00317-40
• Status: Recruiting
• Phase: N/A
• First received: January 14, 2016
• Last updated: August 25, 2016
• Start date: February 2016
• Est. completion date: December 2019

Study information

• Verified date: August 2016
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Etienne Audureau, Md, PhD
• Phone: (0)1 49 81 36 64
• Email: etienne.audureau[@]aphp.fr
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Neoplasms
• Prostatic Neoplasms

Locations

Country	Name	City	State
France	Hôpital Henri Mondor	Créteil
France	CHRU Nancy	Nancy
France	Hôpital Saint Louis	Paris

Sponsors (9)

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

Country where clinical trial is conducted

France, 

Outcome

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