Quality of Life of Patients Over 75 Yars Undergoing Palliative Chemotherapy

NCT ID: NCT04517448

Last Updated: 2024-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

31 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-16

Study Completion Date

2021-11-23

Brief Summary

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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

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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.

Conditions

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Colorectal Cancer Pancreatic Cancer Biliary Cancer Hepatic Cancer Oesophageal Cancer Gastric Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier de la côte Basque

OTHER

Sponsor Role lead

Responsible Party

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AUDEMAR Franck

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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CH Côte Basque

Bayonne, , France

Site Status

Countries

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France

Other Identifiers

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P-2020/01

Identifier Type: -

Identifier Source: org_study_id

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