Clinical trial NCT06079229: Quality of Life in Elderly Patients After Pancreatic Cancer Surgery
Official title: Pilot Study of Geriatric Parameters and Quality of Life in Patients Over 70 Years Old Undergoing Pancreatic Cancer Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Cancer
Surgery
Elderly
Keywords: Pancreatic cancer
pancreatectomy
pancreatic surgery
independence
quality of life
elderly people
octogenarian
geriatric assessment
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2023-10-12
Enrollment: 12
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Evolution in the ADL questionnaire score between pre-operative and post-operative 3 to 30 months after surgery.
timeFrame: Between 3 months and 30 months after surgery.
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Service de Gériatrie aigue, Hôpital Edouard Herriot, Hospices Civils de Lyon
Study officials:
affiliation: Service de Gériatrie aigue, Hôpital Édouard Herriot, Hospices Civils de Lyon
name: Byeul-A KIM, MD
role: PRINCIPAL_INVESTIGATOR
References: