Clinical trial NCT04517448: Quality of Life of Patients Over 75 Yars Undergoing Palliative Chemotherapy
Official title: Quality of Life of Patients Over 75 Yars Undergoing Palliative Chemotherapy for Digestive Cancer
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Colorectal Cancer
Pancreatic Cancer
Biliary Cancer
Hepatic Cancer
Oesophageal Cancer
Gastric Cancer
Keywords: Digestive cancer, age other 75 years old, palliative therapy, quality of life
Lead sponsor: Centre Hospitalier de la côte Basque
Sponsor class: OTHER
First posted: 2020-08-18
Enrollment: 31
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_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.

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.

Detailed description: The number of patients undergoing chemotherapy continues to increase as well as the age of cancer patients, it is estimated that in 2050 one cancer out of two will be discovered in a person over 75 years of age. Digestive cancers account for the majority of these patients, the goals of these palliative chemotherapies are to improve survival and maintain or improve quality of life. Since the 2009 cancer plan, a specific geriatric onco-geriatrics organization has been set up with the creation of geriatric onco-coordination units. One of the objectives of this plan is to achieve a 5% inclusion rate of patients over 75 years of age in clinical trials. However, there are relatively few studies in patients over 75 years of age concerning quality of life, as they are often excluded from trials and survival is preferred as the primary outcome. This observational study evaluates the quality of life of patients at the time of the first chemotherapy treatment and then at the end of the first cycle of chemotherapy at 3 months by a standardized questionnaire, an evaluation of autonomy and the number of days of hospitalization.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Change in the response scores to the standardized questionnaire Quality of life questionnaire in cancer patient
timeFrame: Before first chemotherapy and at Month 3 of chemotherapy
Secondary outcomes:
measure: Change in the Activity of daily living score
timeFrame: Before first chemotherapy and at Month 3 of chemotherapy
Other outcomes:
Locations:
city: Bayonne
country: France
facility: CH Côte Basque
Study officials:
References: