Breast CancerONCODAGENCT00963911
Validation of a Screening Tool in Geriatric Oncology
A study testing Geriatric screening tests and Multidimensional geriatric assessment in people with Breast Cancer and Colorectal Cancer, run by Institut Bergonié at 1 site in France.
Trial summary
RATIONALE: A screening questionnaire may help doctors plan better treatment for older patients with cancer. PURPOSE: This clinical trial is studying a questionnaire in screening older patients with cancer. Read more about this study
- Who is it for?
- Ages 70 to 120 years
- Conditions the study is for
- Breast Cancer, Colorectal Cancer, Head and Neck Cancer
- What is being tested?
- Geriatric screening tests and Multidimensional geriatric assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,674 participants
- Where
- 1 siteFrance
- Study dates
- 5 Aug 2008to 8 Mar 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 120 years
- All sexes
- No healthy volunteers
- Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed cancer including the following types:
- Colon
- Rectal
- Lung
- Squamous cell carcinoma of the head and neck
- Breast
- Prostate
- Non-Hodgkin lymphoma
- Planning to undergo first-time treatment comprising medicine, surgery, or radiotherapy
PATIENT CHARACTERISTICS:
- No persons deprived of liberty or under guardianship
- No psychological, familial, social, or geographical reasons that would make monitoring clinically impossible
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Trial locations and contacts
1 site in 1 country.
About this study
RATIONALE: A screening questionnaire may help doctors plan better treatment for older patients with cancer.
PURPOSE: This clinical trial is studying a questionnaire in screening older patients with cancer.
Read the detailed description
OBJECTIVES:
Primary
- Validate a new screening tool (G8).
Secondary
- Validate the French version of the screening tool "Vulnerable Elders Survey (VES-13)".
- Evaluate the merits of the screening tools (G8 and VES-13).
- Assess the screening tool in specific populations.
- Assess the number and type of interventions proposed after thorough geriatric assessment.
- Compare the two new tools (G8 vs VES-13).
OUTLINE: This is a multicenter study.
During the first consultation, patients have an initial clinical evaluation questionnaire comprising the G8. They also complete the self-questionnaire VES-13. Within 30 days, patients have a thorough geriatric assessment, including quality of life and physical function, by a physician without access to the G8 or VES-13 questionnaires. A blood specimen is also collected.
Information on health status and quality of life is collected from medical records or from the doctor after 1 and 5 years.
- Conditions
- Breast Cancer, Colorectal Cancer, Head and Neck Cancer, Lung Cancer, Lymphoma, Prostate Cancer
- Being tested
- Geriatric screening tests, Multidimensional geriatric assessment
- Keywords
- colon cancer, rectal cancer, non-small cell lung cancer, small cell lung cancer, hypopharyngeal squamous cell carcinoma, laryngeal squamous cell carcinoma, laryngeal verrucous carcinoma, lip and oral cavity squamous cell carcinoma, oral cavity verrucous carcinoma, nasopharyngeal squamous cell carcinoma, oropharyngeal squamous cell carcinoma, paranasal sinus and nasal cavity squamous cell carcinoma, salivary gland squamous cell carcinoma, prostate cancer, breast cancer, adult non-Hodgkin lymphoma
- Medical subject headings
- Breast Neoplasms, Colorectal Neoplasms, Head and Neck Neoplasms, Lung Neoplasms, Lymphoma, Prostatic Neoplasms, Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Geriatric screening testsOther
Also called G-8
The G-8 consists of eight items: patient age (>85, 80-85, <80), and seven items from the original 18-item MNA (Mini Nutritional Assessment: appetite changes, weight loss, mobility, neuropsychological problems, body mass index, medication, and self-rated health). The total score ranges from 0 to 17, with lower scores indicating a higher risk of impairments. The cut-off value for an 'impaired' reference test score was <=14 and the time taken to complete the test was recorded.
VES-13 is a self-administered questionnaire that was completed during the first visit after enrollment. For three pre-identified centers, patients also filled in the questionnaire at the following geriatric visit. VES-13 consisted of four groups of questions: age, self-perceived health, difficulties to perform six specific activities, and difficulties to perform daily living tasks due to health concerns. The score ranged from 0 to 10 and a score >=3 was considered to show impairment.
Multidimensional geriatric assessmentOther
Also called MGA
Patients underwent a geriatric evaluation in the month following the completion of G8 and VES-13 (+/- seven days) before treatment began. The nurse completed six of the seven instruments of the MGA (MNA, Timed Get up and Go (TUG), Activities of Daily Living (ADL), Instrumental ADL (IADL), Mini Mental State Examination (MMSE), and Geriatric Depression Scale (GDS-15)), and the geriatrician rated comorbidity on the Cumulative Illness Rating Scale (CIRS-G), recorded the time required for the consultation, identified patients who needed personalized geriatric interventions, and, if necessary, proposed further geriatric evaluation (outside of the scope of this study).
| Study group | Role | What they receive |
|---|---|---|
| Included patients | Experimental | Screening tests (G8 and VES-13) Receives: Other: Geriatric screening tests; Other: Multidimensional geriatric assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of the G8 Questionnaire
Sensitivity of the G8 questionnaire measured as Percentage of Participants with a Positive G8 among patients with a positive MGA. The G8 consists of eight items: patient age (>85, 80-85, <80), and seven items from the original 18-item MNA (Mini Nutritional Assessment: appetite changes, weight loss, mobility, neuropsychological problems, body mass index, medication, and self-rated health). The total score ranges from 0 to 17, with lower scores indicating a higher risk of impairments. The cut-off value for an 'impaired' reference test score was <=14.
Multidimensional geriatric assessment (MGA): Patients underwent a geriatric evaluation in the month following the completion of VES-13. The nurse completed six instruments of the MGA (MNA, Timed Get up and Go, Activities of Daily Living (ADL), Instrumental ADL, Mini Mental State Examination, and Geriatric Depression Scale, and the geriatrician rated comorbidity on the Cumulative Illnes Rating Scale.
Measured: at inclusion (at completion of the G8 questionnaire)
Secondary outcomes (5)
Specificity of the G8 Questionnaire
Specificity of the G8 questionnaire measured as percentage of participants with a negative G8 test among patients with a negative MGA.The G8 consists of eight items: patient age (>85, 80-85, <80), and seven items from the original 18-item MNA (Mini Nutritional Assessment: appetite changes, weight loss, mobility, neuropsychological problems, body mass index, medication, and self-rated health). The total score ranges from 0 to 17, with lower scores indicating a higher risk of impairments. The cut-off value for an 'impaired' reference test score was <=14.
Multidimensional geriatric assessment (MGA): Patients underwent a geriatric evaluation in the month following the completion of VES-13. The nurse completed six instruments of the MGA (MNA, Timed Get up and Go, Activities of Daily Living (ADL), Instrumental ADL, Mini Mental State Examination, and Geriatric Depression Scale, and the geriatrician rated comorbidity on the Cumulative Illnes Rating Scale.
Measured: at inclusion (at completion of the G8 questionnaire)
Sensitivity of the VES-13 Questionnaire
Sensitivity of the VES-13 questionnaire measured as percentage of participants with a positive VES-13 test among patients with a positive MGA. VES-13 is a self-administered questionnaire that was completed during the first visit after enrollment. For 3 pre-identified centers, patients filled in the questionnaire at the following geriatric visit. VES-13 consisted of 4 groups of questions: age, self-perceived health, difficulties to perform 6 specific activities, and difficulties to perform daily living tasks due to health concerns. The score ranged from 0 to 10 and a score >=3 was considered to show impairment.
Multidimensional geriatric assessment (MGA): see measure description for primary outcome.
Measured: at inclusion
Specificity of the VES-13 Questionnaire
Specificity of the VES-13 questionnaire measure as the percentage of participants with a negative VES-13 test among patients with a negative MGA. VES-13 is a self-administered questionnaire that was completed during the first visit after enrollment. For 3 pre-identified centers, patients filled in the questionnaire at the following geriatric visit. VES-13 consisted of 4 groups of questions: age, self-perceived health, difficulties to perform 6 specific activities, and difficulties to perform daily living tasks due to health concerns. The score ranged from 0 to 10 and a score >=3 was considered to show impairment.
Multidimensional geriatric assessment (MGA): see measure description for primary outcome.
Measured: at inclusion (at completion of the G8 questionnaire)
Reproducibility of the G8 Questionnaire
Reproducibility of G8 was assessed by comparing the score on the actual G8 with the scores extracted from the corresponding seven questions of MNA completed during the MGA for all patients. The G8 consists of eight items: patient age (>85, 80-85, <80), and seven items from the original 18-item MNA (Mini Nutritional Assessment: appetite changes, weight loss, mobility, neuropsychological problems, body mass index, medication, and self-rated health). The total score ranges from 0 to 17, with lower scores indicating a higher risk of impairments. The cut-off value for an 'impaired' reference test score was <=14.
Measured: at inclusion (at completion of the G8 questionnaire)
Reproducibility of the VES-13 Questionnaire
Reproducibility of VES-13 was assessed based on a subgroup of patients included in three pre-identified centers who completed the questionnaire on two occasions. VES-13 is a self-administered questionnaire that was completed during the first visit after enrollment. For 3 pre-identified centers, patients filled in the questionnaire at the following geriatric visit. VES-13 consisted of 4 groups of questions: age, self-perceived health, difficulties to perform 6 specific activities, and difficulties to perform daily living tasks due to health concerns. The score ranged from 0 to 10 and a score >=3 was considered to show impairment.
Measured: at inclusion (at completion of the G8 questionnaire)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2009 (estimated)
- Study start5 Aug 2008
- Primary completion8 Mar 2010
- Study completion8 Mar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,674 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Bergonié
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute, France
- Responsible party
- Sponsor
- Investigators
- Pierre Soubeyran, MD, PhD, Principal investigator, Institut Bergonié
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00963911
- Sponsor's protocol ID
- IB 2008-06
- Other IDs
- IB-ONCODAGE, IB 2008-06, 2008-A00322-53
- Acronym
- ONCODAGE
- Status last verified
- Mar 2021
- First submitted
- 21 Aug 2009
- Last updated
- 5 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bellera CA, Artaud F, Rainfray M, Soubeyran PL, Mathoulin-Pelissier S. Modeling individual and relative accuracy of screening tools in geriatric oncology. Ann Oncol. 2017 May 1;28(5):1152-1157. doi: 10.1093/annonc/mdx068.
PubMed 28327973Soubeyran P, Bellera C, Goyard J, Heitz D, Cure H, Rousselot H, Albrand G, Servent V, Jean OS, van Praagh I, Kurtz JE, Perin S, Verhaeghe JL, Terret C, Desauw C, Girre V, Mertens C, Mathoulin-Pelissier S, Rainfray M. Screening for vulnerability in older cancer patients: the ONCODAGE Prospective Multicenter Cohort Study. PLoS One. 2014 Dec 11;9(12):e115060. doi: 10.1371/journal.pone.0115060. eCollection 2014.
PubMed 25503576
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Screening Tool in Geriatric Oncology
- ClinicalTrials.gov ID
- NCT00963911
- Acronym / sponsor ID
- ONCODAGE / IB 2008-06
- Conditions
- Breast Cancer, Colorectal Cancer, Head and Neck Cancer, Lung Cancer, Lymphoma, Prostate Cancer
- Keywords
- colon cancer, rectal cancer, non-small cell lung cancer, small cell lung cancer, hypopharyngeal squamous cell carcinoma, laryngeal squamous cell carcinoma, laryngeal verrucous carcinoma, lip and oral cavity squamous cell carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,674 participants (actual)
- Lead sponsor
- Institut BergoniéUniversity, hospital or other
- Collaborators
- National Cancer Institute, France
- Study start
- 5 Aug 2008 (actual)
- Primary completion
- 8 Mar 2010 (actual)
- Study completion
- 8 Mar 2015 (actual)
- First posted
- 24 Aug 2009 (estimated)
- Results
- Posted 26 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: A screening questionnaire may help doctors plan better treatment for older patients with cancer.
PURPOSE: This clinical trial is studying a questionnaire in screening older patients with cancer.
Detailed description
OBJECTIVES:
Primary
- Validate a new screening tool (G8).
Secondary
- Validate the French version of the screening tool "Vulnerable Elders Survey (VES-13)".
- Evaluate the merits of the screening tools (G8 and VES-13).
- Assess the screening tool in specific populations.
- Assess the number and type of interventions proposed after thorough geriatric assessment.
- Compare the two new tools (G8 vs VES-13).
OUTLINE: This is a multicenter study.
During the first consultation, patients have an initial clinical evaluation questionnaire comprising the G8. They also complete the self-questionnaire VES-13. Within 30 days, patients have a thorough geriatric assessment, including quality of life and physical function, by a physician without access to the G8 or VES-13 questionnaires. A blood specimen is also collected.
Information on health status and quality of life is collected from medical records or from the doctor after 1 and 5 years.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Included patients | Experimental | Other: Geriatric screening tests, Other: Multidimensional geriatric assessmentScreening tests (G8 and VES-13) |
Who may qualify
- Ages
- 70 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
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 |
|---|---|---|
| Geriatric screening testsAlso: G-8The G-8 consists of eight items: patient age (>85, 80-85, <80), and seven items from the original 18-item MNA (Mini Nutritional Assessment: appetite changes, weight loss, mobility, neuropsychological problems, body mass index, medication, and self-rated health). The total score ranges from 0 to 17, with lower scores indicating a higher risk of impairments. The cut-off value for an 'impaired' reference test score was <=14 and the time taken to complete the test was recorded. VES-13 is a self-administered questionnaire that was completed during the first visit after enrollment. For three pre-identified centers, patients also filled in the questionnaire at the following geriatric visit. VES-13 consisted of four groups of questions: age, self-perceived health, difficulties to perform six specific activities, and difficulties to perform daily living tasks due to health concerns. The score ranged from 0 to 10 and a score >=3 was considered to show impairment. | Other | Included patients |
| Multidimensional geriatric assessmentAlso: MGAPatients underwent a geriatric evaluation in the month following the completion of G8 and VES-13 (+/- seven days) before treatment began. The nurse completed six of the seven instruments of the MGA (MNA, Timed Get up and Go (TUG), Activities of Daily Living (ADL), Instrumental ADL (IADL), Mini Mental State Examination (MMSE), and Geriatric Depression Scale (GDS-15)), and the geriatrician rated comorbidity on the Cumulative Illness Rating Scale (CIRS-G), recorded the time required for the consultation, identified patients who needed personalized geriatric interventions, and, if necessary, proposed further geriatric evaluation (outside of the scope of this study). | Other | Included patients |
Primary outcome
Sensitivity of the G8 Questionnaire
Time frame: at inclusion (at completion of the G8 questionnaire)
Sensitivity of the G8 questionnaire measured as Percentage of Participants with a Positive G8 among patients with a positive MGA. The G8 consists of eight items: patient age (>85, 80-85, <80), and seven items from the original 18-item MNA (Mini Nutritional Assessment: appetite changes, weight loss, mobility, neuropsychological problems, body mass index, medication, and self-rated health). The total score ranges from 0 to 17, with lower scores indicating a higher risk of impairments. The cut-off value for an 'impaired' reference test score was <=14. Multidimensional geriatric assessment (MGA): Patients underwent a geriatric evaluation in the month following the completion of VES-13. The nurse completed six instruments of the MGA (MNA, Timed Get up and Go, Activities of Daily Living (ADL), Instrumental ADL, Mini Mental State Examination, and Geriatric Depression Scale, and the geriatrician rated comorbidity on the Cumulative Illnes Rating Scale.
5 secondary outcomes
Specificity of the G8 Questionnaire
Time frame: at inclusion (at completion of the G8 questionnaire)
Sensitivity of the VES-13 Questionnaire
Time frame: at inclusion
Specificity of the VES-13 Questionnaire
Time frame: at inclusion (at completion of the G8 questionnaire)
Reproducibility of the G8 Questionnaire
Time frame: at inclusion (at completion of the G8 questionnaire)
Reproducibility of the VES-13 Questionnaire
Time frame: at inclusion (at completion of the G8 questionnaire)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28327973Bellera CA, Artaud F, Rainfray M, Soubeyran PL, Mathoulin-Pelissier S. Modeling individual and relative accuracy of screening tools in geriatric oncology. Ann Oncol. 2017 May 1;28(5):1152-1157. doi: 10.1093/annonc/mdx068.
- Results publication: PubMed 25503576Soubeyran P, Bellera C, Goyard J, Heitz D, Cure H, Rousselot H, Albrand G, Servent V, Jean OS, van Praagh I, Kurtz JE, Perin S, Verhaeghe JL, Terret C, Desauw C, Girre V, Mertens C, Mathoulin-Pelissier S, Rainfray M. Screening for vulnerability in older cancer patients: the ONCODAGE Prospective Multicenter Cohort Study. PLoS One. 2014 Dec 11;9(12):e115060. doi: 10.1371/journal.pone.0115060. eCollection 2014.
- Individual participant dataSharing planned: No
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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.
Pierre Soubeyran, MD, PhD principal investigator
Institut Bergonié
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Geriatric screening tests and Multidimensional geriatric assessment in people with Breast Cancer and Colorectal Cancer, run by Institut Bergonié 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?
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 5 Apr 2021. 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?
Yes. Results are posted in the registry (first posted 26 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Sensitivity of the G8 Questionnaire (time frame: at inclusion (at completion of the G8 questionnaire)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00963911, which also lists 2 linked publications.
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 5 Apr 2021.