Quality of Life of Patients Over 75 Yars Undergoing Palliative Chemotherapy

Colorectal Cancer Clinical Trial

— EQLVCPAL  

Official title:

Quality of Life of Patients Over 75 Yars Undergoing Palliative Chemotherapy for Digestive Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04517448
• Other study ID #: P-2020/01
• Status: Recruiting
• Start date: October 16, 2020
• Est. completion date: March 15, 2022

Study information

• Verified date: October 2021
• Source: Centre Hospitalier de la côte Basque
• Contact: Franck AUDEMAR
• Phone: +33559443726
• Email: faudemar[@]ch-cotebasque.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 15, 2022
• Est. primary completion date: December 15, 2021
• Gender: All
• Age group: 75 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Biliary Cancer
• Colorectal Cancer
• Gastric Cancer
• Hepatic Cancer
• Liver Neoplasms
• Oesophageal Cancer
• Pancreatic Cancer

Locations

Country	Name	City	State
France	CH Côte Basque	Bayonne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier de la côte Basque

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the response scores to the standardized questionnaire Quality of life questionnaire in cancer patient	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	Before first chemotherapy and at Month 3 of chemotherapy
Secondary	Change in the Activity of daily living score	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.	Before first chemotherapy and at Month 3 of chemotherapy