Colorectal CancerEQLVCPALNCT04517448
Quality of Life of Patients Over 75 Yars Undergoing Palliative Chemotherapy
An observational study of Colorectal Cancer and Pancreatic Cancer, run by Centre Hospitalier de la côte Basque at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Colorectal Cancer, Pancreatic Cancer, Biliary Cancer
- How many people
- 31 participants
- Where
- 1 siteFrance
- Study dates
- 16 Oct 2020to 23 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- Older adult
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.
Who may be able to join
- 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
Who cannot join
- Cognitive disorders
- Patient benefiting from a legal protection measure
- Life expectancy below 1 year
- Not understanding french language
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quality of Life of Patients Over 75 Yars Undergoing Palliative Chemotherapy for Digestive Cancer
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.
Read the 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.
- 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
- Medical subject headings
- Colorectal Neoplasms, Pancreatic Neoplasms, Biliary Tract Neoplasms, Liver Neoplasms, Esophageal Neoplasms, Stomach Neoplasms, Gastrointestinal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Before first chemotherapy and at Month 3 of chemotherapy
Secondary outcomes (1)
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.
Measured: Before first chemotherapy and at Month 3 of chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2020
- Study start16 Oct 2020
- Primary completion23 Oct 2021
- Study completion23 Nov 2021
Why it stopped: End of recruitment - Number of required subjects enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de la côte Basque
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AUDEMAR Franck, Centre Hospitalier de la côte Basque
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04517448
- Sponsor's protocol ID
- P-2020/01
- Acronym
- EQLVCPAL
- Status last verified
- Sep 2024
- First submitted
- 14 Aug 2020
- Last updated
- 26 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life of Patients Over 75 Yars Undergoing Palliative Chemotherapy for Digestive Cancer
- ClinicalTrials.gov ID
- NCT04517448
- Acronym / sponsor ID
- EQLVCPAL / P-2020/01
- 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
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: End of recruitment - Number of required subjects enrolled
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Centre Hospitalier de la côte BasqueUniversity, hospital or other
- Study start
- 16 Oct 2020 (actual)
- Primary completion
- 23 Oct 2021 (actual)
- Study completion
- 23 Nov 2021 (actual)
- First posted
- 18 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Age groups
- Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- Cognitive disorders
- Patient benefiting from a legal protection measure
- Life expectancy below 1 year
- Not understanding french language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in the response scores to the standardized questionnaire Quality of life questionnaire in cancer patient
Time frame: Before first chemotherapy and at Month 3 of chemotherapy
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
1 secondary outcome
Change in the Activity of daily living score
Time frame: Before first chemotherapy and at Month 3 of chemotherapy
Results and safety
The study was stopped early (reason given: End of recruitment - Number of required subjects enrolled). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Pancreatic Cancer, run by Centre Hospitalier de la côte Basque at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: End of recruitment - Number of required subjects enrolled). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the response scores to the standardized questionnaire Quality of life questionnaire in cancer patient (time frame: Before first chemotherapy and at Month 3 of chemotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2024.