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| Name | Class |
|---|---|
| Paris 12 Val de Marne University | OTHER |
| Research Team APEMAC EA4360, University of Lorraine | UNKNOWN |
| Unité de Recherche Clinique Mondor, Hôpital Henri Mondor | UNKNOWN |
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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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Patients
Inclusion Criteria:
Exclusion Criteria:
Caregivers Inclusion criteria
Exclusion criteria
- Physical, cognitive or linguistic incapacity to complete questionnaires
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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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Etienne Audureau, Md, PhD | Contact | (0)1 49 81 36 64 | +33 | etienne.audureau@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Christine Perret-Guillaume | Central Hospital, Nancy, France | Study Chair |
| Elena Paillaud | Hôpital Albert Chenevier | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Henri Mondor | Recruiting | Créteil | 94010 | France |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D011471 | Prostatic Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| Institut de Cancérologie de Lorraine |
| OTHER |
| Unité de Coordination en Onco-Gériatrie (UCOG) Sud Val-de-Marne | UNKNOWN |
| Quality of life and cancer clinical research platform | UNKNOWN |
| Ligue contre le cancer, France | OTHER |
| Conseil Régional de Lorraine, France | UNKNOWN |
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| 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 |
| CHRU Nancy | Recruiting | Nancy | 54000 | France |
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| Hôpital Saint Louis | Recruiting | Paris | 75010 | France |
|
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |