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OpenTrials
Completed

NCT Number: NCT06079229

Quality of Life in Elderly Patients After 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.

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Key information

Age range

70 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Service de Gériatrie aigue, Hôpital Edouard Herriot, Hospices Civils de Lyon

Lyon, 69003, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

phone call

Other

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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: ADL_DPC_PA

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 12, 2023
Registry last updated
May 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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