Quality of Life of Patients Over 75 Yars Undergoing Palliative Chemotherapy (EQLVCPAL)

October 27, 2021 updated by: AUDEMAR Franck, Centre Hospitalier de la côte Basque

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

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

75 years and older (Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patient other 75 years old, undergoing a palliative chemotherapy for a digestive cancer : colorectal, pancreatic, biliary, oesophageal, gastric, proved by histology, whatever the histologic type (adenocarcinoma, epidermoid carcinoma, neuroendocrine carcinoma); at a palliative stage (not resecable, multimetastatic) and who will perform a first course of palliative chemotherapy.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the response scores to the standardized questionnaire Quality of life questionnaire in cancer patient
Time Frame: 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
Before first chemotherapy and at Month 3 of chemotherapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the Activity of daily living score
Time Frame: 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.
Before first chemotherapy and at Month 3 of chemotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier de la côte Basque

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 16, 2020

Primary Completion (Anticipated)

December 15, 2021

Study Completion (Anticipated)

March 15, 2022

Study Registration Dates

First Submitted

August 14, 2020

First Submitted That Met QC Criteria

August 14, 2020

First Posted (Actual)

August 18, 2020

Study Record Updates

Last Update Posted (Actual)

November 3, 2021

Last Update Submitted That Met QC Criteria

October 27, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P-2020/01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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