NCT04517448

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 14, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 18, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

October 16, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 23, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 23, 2021

Completed
Last Updated

September 26, 2024

Status Verified

September 1, 2024

Enrollment Period

1 year

First QC Date

August 14, 2020

Last Update Submit

September 24, 2024

Conditions

Keywords

Digestive cancer, age other 75 years old, palliative therapy, quality of life

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Change in the Activity of daily living score

    Before first chemotherapy and at Month 3 of chemotherapy

Eligibility Criteria

Age75 Years+
Sexall
Age GroupsOlder Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CH Côte Basque

Bayonne, 64109, France

Location

MeSH Terms

Conditions

Colorectal NeoplasmsPancreatic NeoplasmsBiliary Tract NeoplasmsLiver NeoplasmsEsophageal NeoplasmsStomach NeoplasmsGastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesEndocrine Gland NeoplasmsPancreatic DiseasesEndocrine System DiseasesBiliary Tract DiseasesLiver DiseasesHead and Neck NeoplasmsEsophageal DiseasesStomach Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

August 14, 2020

First Posted

August 18, 2020

Study Start

October 16, 2020

Primary Completion

October 23, 2021

Study Completion

November 23, 2021

Last Updated

September 26, 2024

Record last verified: 2024-09

Locations