Quality of Life of Patients Over 75 Yars Undergoing Palliative Chemotherapy

• Conditions: Pancreatic Cancer; Biliary Cancer; Hepatic Cancer; Gastric Cancer; Colorectal Cancer; Oesophageal Cancer

• Registration Number: NCT04517448
• Lead Sponsor: Centre Hospitalier de la côte Basque

Brief Summary

The aim of this research is to evaluate the quality of life of patients over 75 years of age undergoing palliative chemotherapy for digestive cancer. It is a non-interventional study that evaluates the quality of life before and after a cycle of chemotherapy with a composite criterion including: a standardized questionnaire "Cancer specific quality of Life questionnaire" (QLQC30), an assessment of autonomy by "Activity of daily living" questionnaire (ADL), and the number of days of hospitalization.

Detailed Description

The number of patients undergoing chemotherapy continues to increase as well as the age of cancer patients, it is estimated that in 2050 one cancer out of two will be discovered in a person over 75 years of age. Digestive cancers account for the majority of these patients, the goals of these palliative chemotherapies are to improve survival and maintain or improve quality of life. Since the 2009 cancer plan, a specific geriatric onco-geriatrics organization has been set up with the creation of geriatric onco-coordination units. One of the objectives of this plan is to achieve a 5% inclusion rate of patients over 75 years of age in clinical trials. However, there are relatively few studies in patients over 75 years of age concerning quality of life, as they are often excluded from trials and survival is preferred as the primary outcome. This observational study evaluates the quality of life of patients at the time of the first chemotherapy treatment and then at the end of the first cycle of chemotherapy at 3 months by a standardized questionnaire, an evaluation of autonomy and the number of days of hospitalization.

Study Timeline

• Study First Submitted: 2020-08-14
• Study First Submitted QC: 2020-08-14
• Study First Posted: 2020-08-18
• Study Start: 2020-10-16
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-27
• Last Update Posted: 2021-11-03
• Primary Completion: 2021-12-15
• Study Completion: 2022-03-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Age over 75 years old
• Suffering from digestive cancer : colorectal, pancreatic, biliary, oesophageal, gastric
• Palliative cancer : not resectable, multimetastatic
• Decision in multi-disciplinary liaising meeting (CPR) to perform a first course of palliative chemotherapy
• Having received an informed consent form
• Understanding french language

Exclusion Criteria

• Cognitive disorders
• Patient benefiting from a legal protection measure
• Life expectancy below 1 year
• Not understanding french language

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in the response scores to the standardized questionnaire Quality of life questionnaire in cancer patient	Before first chemotherapy and at Month 3 of chemotherapy	The primary outcome is a composite criterion comparing the response scores to the standardized questionnaire Quality of life in cancer patient . These data will be collected during the first inpatient chemotherapy course in hospitalization and during the last chemotherapy before evaluation. A higher score would mean a worsening of the situation

Secondary Outcome Measures

Name	Time	Method
Change in the Activity of daily living score	Before first chemotherapy and at Month 3 of chemotherapy	The secondary outcome in to compare the Activity of daily living score at first chemotherapy and at the end of the first cycle at 3 months. We will collect the patient's place of residence in order to look for possible institutionalization, which is an important marker of quality of life. A higher score would mean a worsening of the situation.

Trial Locations

Locations (1)

CH Côte Basque; 🇫🇷 Bayonne, France