CancerepigacNCT02000011
Interest of a Geriatric Intervention Plan Associated to a Comprehensive Geriatric Assessment on Autonomy, Quality of Life and Survival of Patients Aged 70 Years Old and More Surgically Treated for a Resectable Cancer (Thoracic, Digestive or Urologic). Randomized Multicentric Study
A study testing comprehensive geriatric assessment (CGA) and Geriatric intervention plan (GIP) in people with Cancer, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
The curative treatment of thoracic (lung and oesophagus), digestive (gastric, pancreatic, hepatic, colorectal), and urologic (renal, bladder, prostatic) cancers needs a surgical resection. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- comprehensive geriatric assessment (CGA) and Geriatric intervention plan (GIP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 23 May 2014to 27 Oct 2022
- Phase
- Interventional
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Male or female aged 70 years old or more
- Patient with a resectable cancer( thoracic, digestive ore urologic);
- Patients who have to undergo a surgery with general anaesthesia;
- Patients treated in one of the partner programme unit ;
- Patient able to fill in an auto-questionnaire alone or with some help;
- Patient who have signed an informed consent and who commits himself or herself to respect the protocol instructions.
Who cannot join
- Patient younger than 70 years old;
- Patient who is not registered to the social ;
- Patient for whom surgery is performed under local anaesthesia;
- Patient unable to fill-in alone an autoquestionnaire (because of an inability to read French language or severe cognitive troubles);
- Patient treated with neuroleptic or lithium ;
- Patient with already known cognitive impairment (Alzheimer, dementia, neurologic sequel);
- Patient under legal protection;
- Patient who has not signed informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
The curative treatment of thoracic (lung and oesophagus), digestive (gastric, pancreatic, hepatic, colorectal), and urologic (renal, bladder, prostatic) cancers needs a surgical resection. For patients aged of 70 years old and more, this surgery is associated to an increased morbid-mortality especially because of more frequent co-morbidities. Comprehensive geriatric assessment (CGA) allows distinguishing patients for whom a resection surgery can be complicated by high morbid-mortality or a loss of autonomy. It has been proved that for old patient population without cancer, CGA associated with a geriatric intervention plan (GIP) allows autonomy preservation, decrease of institution admission, and survival improvement. The reference study showed that a CGA associated to a GIP improves survival of old patients who had a cancer surgery. However this study included patients from 60 years old and the GIP consisted in 3 home visits and 5 phone calls during the 4 weeks following hospital discharge.
We propose to perform a prospective and randomized study to evaluate the impact of a CGA with GIP in 70 years old and more patients with a thoracic, digestive or urologic cancer resection, respectively 1, 3, 6 and 12 months after discharge. CGA and GIP will focus on 8 distinct fields: autonomy, co-morbidities, co-medication, mobility, nutritional status, depression, cognitive function and social status. The impact of such a strategy on autonomy and survival has never been studied.
- Conditions
- Cancer
- Being tested
- comprehensive geriatric assessment (CGA), Geriatric intervention plan (GIP)
- Keywords
- patients, aged 70 years old, thoracic,, digestive or, urological, resectable
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
comprehensive geriatric assessment (CGA)Other
Geriatric intervention plan (GIP)Other
| Study group | Role | What they receive |
|---|---|---|
| standard strategy | Other | Not described Receives: Other: comprehensive geriatric assessment (CGA) |
| experimental strategy | Experimental | Not described Receives: Other: comprehensive geriatric assessment (CGA); Other: Geriatric intervention plan (GIP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
the 6-month autonomy after surgery
Measured: 24 MONTHS
Secondary outcomes (1)
12-month autonomy
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2013 (estimated)
- Study start23 May 2014
- Primary completion18 Apr 2016
- Study completion27 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- LOIC MONDOLONI, Study director, Assistance Publique Hopitaux De Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02000011
- Sponsor's protocol ID
- 2013-A01038-37
- Other IDs
- 2013-33
- Acronym
- epigac
- Status last verified
- Nov 2022
- First submitted
- 26 Nov 2013
- Last updated
- 14 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of a Geriatric Intervention Plan Associated to a Comprehensive Geriatric Assessment on Autonomy, Quality of Life and Survival of Patients Aged 70 Years Old and More Surgically Treated for a Resectable Cancer (Thoracic, Digestive or Urologic). Randomized Multicentric Study
- ClinicalTrials.gov ID
- NCT02000011
- Acronym / sponsor ID
- epigac / 2013-A01038-37
- Conditions
- Cancer
- Keywords
- patients, aged 70 years old, thoracic,, digestive or, urological, resectable
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 23 May 2014 (actual)
- Primary completion
- 18 Apr 2016 (actual)
- Study completion
- 27 Oct 2022 (actual)
- First posted
- 3 Dec 2013 (estimated)
- 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 curative treatment of thoracic (lung and oesophagus), digestive (gastric, pancreatic, hepatic, colorectal), and urologic (renal, bladder, prostatic) cancers needs a surgical resection. For patients aged of 70 years old and more, this surgery is associated to an increased morbid-mortality especially because of more frequent co-morbidities. Comprehensive geriatric assessment (CGA) allows distinguishing patients for whom a resection surgery can be complicated by high morbid-mortality or a loss of autonomy. It has been proved that for old patient population without cancer, CGA associated with a geriatric intervention plan (GIP) allows autonomy preservation, decrease of institution admission, and survival improvement. The reference study showed that a CGA associated to a GIP improves survival of old patients who had a cancer surgery. However this study included patients from 60 years old and the GIP consisted in 3 home visits and 5 phone calls during the 4 weeks following hospital discharge.
We propose to perform a prospective and randomized study to evaluate the impact of a CGA with GIP in 70 years old and more patients with a thoracic, digestive or urologic cancer resection, respectively 1, 3, 6 and 12 months after discharge. CGA and GIP will focus on 8 distinct fields: autonomy, co-morbidities, co-medication, mobility, nutritional status, depression, cognitive function and social status. The impact of such a strategy on autonomy and survival has never been studied.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard strategy | Other | Other: comprehensive geriatric assessment (CGA) |
| experimental strategy | Experimental | Other: comprehensive geriatric assessment (CGA), Other: Geriatric intervention plan (GIP) |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Male or female aged 70 years old or more
- Patient with a resectable cancer( thoracic, digestive ore urologic);
- Patients who have to undergo a surgery with general anaesthesia;
- Patients treated in one of the partner programme unit ;
- Patient able to fill in an auto-questionnaire alone or with some help;
Key exclusion criteria (8 listed)
- Patient younger than 70 years old;
- Patient who is not registered to the social ;
- Patient for whom surgery is performed under local anaesthesia;
- Patient unable to fill-in alone an autoquestionnaire (because of an inability to read French language or severe cognitive troubles);
- Patient treated with neuroleptic or lithium ;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| comprehensive geriatric assessment (CGA) | Other | experimental strategy, standard strategy |
| Geriatric intervention plan (GIP) | Other | experimental strategy |
Primary outcome
the 6-month autonomy after surgery
Time frame: 24 MONTHS
1 secondary outcome
12-month autonomy
Time frame: 48 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
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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.
LOIC MONDOLONI study director
Assistance Publique Hopitaux De Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing comprehensive geriatric assessment (CGA) and Geriatric intervention plan (GIP) in people with Cancer, run by Assistance Publique Hopitaux De Marseille 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 8 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: finished, as of the sponsor's last update on 14 Nov 2022. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
the 6-month autonomy after surgery (time frame: 24 MONTHS). 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 14 Nov 2022.