Quality of Life in Elderly Patients After Pancreatic Cancer Surgery (ADL_DPC_PA)

May 24, 2024 updated by: Hospices Civils de Lyon

Pilot Study of Geriatric Parameters and Quality of Life in Patients Over 70 Years Old Undergoing Pancreatic Cancer Surgery

Pancreatic cancer mainly affects the elderly, with over 85% of patients diagnosed after the age of 60 and over half after the age of 70. In France, the incidence of pancreatic cancer is currently around 14,000 new cases per year, making it the fourth leading cause of cancer death in women and the fifth in men.

Surgery is currently the only curative option available to patients, but it is not an option for many patients who already have metastatic or locally advanced cancer at the time of diagnosis. The main studies carried out on this type of intervention in the elderly focus on the surgical aspect, and the tolerability of such surgery is not well studied.

The aim of this study is to describe the impact of pancreatic surgery on the independence in daily activities and quality of life of patients aged over 70 with pancreatic cancer. These patients underwent surgery at Édouard Herriot Hospital (Hospices Civils de Lyon) since July 2021, and the assessment will be conducted through telephone questionnaires.

It is hypothesised that these patients will be able to maintain their independence in terms of daily activities.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

12

Contacts and Locations

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

Study Locations

  • France
      • Lyon, France, 69003
        • Service de Gériatrie aigue, Hôpital Edouard Herriot, Hospices Civils de Lyon

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

  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This study focuses on adult patients over the age of 70 with pancreatic cancer (of any type) who have undergone pancreatectomy and have been operated on at the Édouard Herriot Hospital, Lyon, France since July 2021.

Description

Inclusion Criteria:

  • Subjects with histologically proven pancreatic cancer (all types) on biopsy or surgical specimen
  • Operated on for this cancer (by cephalic duodenopancreatectomy or left pancreatectomy) at the Édouard Herriot Hospital since July 2021
  • 70 years of age or older at the time of surgery.

Exclusion Criteria:

  • Patients who have expressed their opposition to the study
  • Patients under curatorship, guardianship or legal protection
  • Patient unable to express non-opposition
  • Patient unreachable after 4 attempted calls over 3 consecutive weeks
  • Patient deceased at the time of the telephone call
  • Persons deprived of their liberty by a judicial or administrative decision
  • Persons under compulsory psychiatric care

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients over 70 undergoing pancreatic cancer surgery at the Édouard Herriot Hospital.
This is a non-comparative study, in which all subjects with histologically proven pancreatic cancer (all types) on biopsy or surgical specimen, operated on for this cancer (by cephalic duodenopancreatectomy or left pancreatectomy) at the Édouard Herriot Hospital since July 2021, aged 70 or older at the time of surgery, will be included in the same group.
Other: Phone call
The only follow-up visit provided for in the protocol was a telephone contact 3 to 30 months after the patient's surgery. The rest of the data required for the study were obtained from the patient's medical records, collected in the course of routine practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evolution in the ADL questionnaire score between pre-operative and post-operative 3 to 30 months after surgery.
Time Frame: Between 3 months and 30 months after surgery.

The ADL score (Activities of Daily Living) is designed to assess independence for activities of daily living. It is scored from 0 to 6, with 6 representing maximum independence for activities of daily living (washing, eating, dressing, etc.) and 0 a complete lack of independence.

The significance of the difference in the ADL score before and after surgery will be tested using the Wilcoxon test.

ADL will therefore be measured at 3 months after surgery at the earliest and at 30 months at the latest, at the time of the telephone call with the patient. The pre-operative value is recorded in the patient's file, measured a few weeks before surgery.
Between 3 months and 30 months after surgery.

Collaborators and Investigators

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

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Byeul-A KIM, MD, Service de Gériatrie aigue, Hôpital Edouard Herriot, Hospices Civils de Lyon

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)

November 6, 2023

Primary Completion (Actual)

April 24, 2024

Study Completion (Actual)

April 24, 2024

Study Registration Dates

First Submitted

October 6, 2023

First Submitted That Met QC Criteria

October 6, 2023

First Posted (Actual)

October 12, 2023

Study Record Updates

Last Update Posted (Actual)

May 28, 2024

Last Update Submitted That Met QC Criteria

May 24, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL23_0569
  • 2023-A01551-44 (Other Identifier: ID-RCB)

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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