Quality of Life in Elderly Patients After Pancreatic Cancer Surgery

Pancreatic Cancer Clinical Trial

— ADL_DPC_PA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06079229
• Other study ID #: 69HCL23_0569
• Secondary ID: 2023-A01551-44
• Status: Completed
• Start date: November 6, 2023
• Est. completion date: April 24, 2024

Study information

• Verified date: May 2024
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: April 24, 2024
• Est. primary completion date: April 24, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Elderly
• Pancreatic Cancer
• Pancreatic Neoplasms
• Surgery

Intervention

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.

Locations

Country	Name	City	State
France	Service de Gériatrie aigue, Hôpital Edouard Herriot, Hospices Civils de Lyon	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evolution in the ADL questionnaire score between pre-operative and post-operative 3 to 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.