Determinants of Quality Of Life in AGEd Cancer Patients

NCT02672657 | Unknown

• 1 other identifier: 2014-A00317-40
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 3

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.

Conditions

Colorectal Neoplasms; Prostatic Neoplasms

Keywords

Health-Related Quality of life; Cancer; Elderly; Caregivers

Outcome Measures

Primary Outcomes (5)

• Changes in HRQoL of patients and their caregivers as assessed by the generic WHOQOL-BREF questionnaires

  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

  At baseline, 3, 6, and 12 months

• Changes in HRQoL of patients as assessed by the specific EORTC-QLQ C30 questionnaire

  At baseline, 3, 6, and 12 months

• Changes in HRQoL of patients as assessed by the specific EORTC QLQ-ELD14 questionnaire

  At baseline, 3, 6, and 12 months

• Changes in burden of patients' caregivers as assessed by the Zarit burden inventory questionnaire

  At baseline, 3, 6, and 12 months

Secondary Outcomes (5)

• Psychometric properties of the HRQoL questionnaire WHOQOL-OLD (validity, reliability, sensitivity to change, feasibility)

  At baseline, 3, 6, and 12 months

• Psychometric properties of the HRQoL questionnaire EORTC QLQ-ELD14 (validity, reliability, sensitivity to change, feasibility)

  At baseline, 3, 6, and 12 months

• Prognostic value of baseline HRQoL measurements on cancer progression-free survival

  At baseline, 3, 6, and 12 months

• Prognostic value of baseline HRQoL measurements on overall survival

  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

  At baseline, 3, 6, and 12 months

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• \- Physical, cognitive or linguistic incapacity to complete questionnaires

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Paris 12 Val de Marne University: collaborator
• Research Team APEMAC EA4360, University of Lorraine: collaborator
• Unité de Recherche Clinique Mondor, Hôpital Henri Mondor: collaborator
• Institut de Cancérologie de Lorraine: collaborator
• Unité de Coordination en Onco-Gériatrie (UCOG) Sud Val-de-Marne: collaborator
• Quality of life and cancer clinical research platform: collaborator
• Ligue contre le cancer, France: collaborator
• Conseil Régional de Lorraine, France: collaborator

Study Sites (3)

Hôpital Henri Mondor

Créteil, 94010, France

RECRUITING

CHRU Nancy

Nancy, 54000, France

RECRUITING

Hôpital Saint Louis

Paris, 75010, France

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms; Prostatic Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

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; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Christine Perret-Guillaume

  Central Hospital, Nancy, France

  STUDY CHAIR

• Elena Paillaud

  Hôpital Albert Chenevier

  STUDY CHAIR

Central Study Contacts

Etienne Audureau, Md, PhD

CONTACT

(0)1 49 81 36 64; etienne.audureau@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2016
• First Posted: February 3, 2016
• Study Start: February 1, 2016
• Primary Completion: February 1, 2019
• Study Completion: December 1, 2019
• Last Updated: August 26, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)