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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04517448
Other study ID # P-2020/01
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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

Study Design


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
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