An observational study in Colorectal Cancer, Pancreatic Cancer and Biliary Cancer, sponsored by Centre Hospitalier de la côte Basque. Terminated at 1 site in France. Open to participants aged 75 Years and older. Per ClinicalTrials.gov, last updated 2024-09-26.
Sponsored by Centre Hospitalier de la côte Basque · Observational
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.
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.
1,391 studies on the registry are indexed under Liver Neoplasms; 345 are open to participants now.
This study's enrollment of 31 is below the median of 200 across 350 observational studies indexed under Liver Neoplasms.
Browse Liver Neoplasms studies →Centre Hospitalier de la côte Basque is the lead sponsor of 5 studies on the registry; 3 are open to participants now.
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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.
Exclusion Criteria:
Change in the response scores to the standardized questionnaire Quality of life questionnaire in cancer patient
The primary outcome is a composite criterion comparing the response scores to the standardized questionnaire Quality of life in cancer patient . These data will be collected during the first inpatient chemotherapy course in hospitalization and during the last chemotherapy before evaluation. A higher score would mean a worsening of the situation
Time frame: Before first chemotherapy and at Month 3 of chemotherapy
Change in the Activity of daily living score
The secondary outcome in to compare the Activity of daily living score at first chemotherapy and at the end of the first cycle at 3 months. We will collect the patient's place of residence in order to look for possible institutionalization, which is an important marker of quality of life. A higher score would mean a worsening of the situation.
Time frame: Before first chemotherapy and at Month 3 of chemotherapy
This study is terminated, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier de la côte Basque