TriangleNCT00963911 · STUDY IN CONTEXT
Validation of a Screening Tool in Geriatric Oncology
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
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.
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.
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.
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.
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.
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.
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-lung-carcinoma
- nct id
- NCT00963911
- trial label
- Validation of a Screening Tool in Geriatric Oncology
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 6
- harms Count
- 1
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-lung-carcinoma
- nct id
- NCT00963911
- outcome key
- om-0000
- source section id
- NCT00963911-om-0000
- source outcome index
- 0
- endpoint
- Sensitivity of the G8 Questionnaire
- endpoint definition
- 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.
- time origin
- at inclusion (at completion of the G8 questionnaire)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Eligible patients assessable for the primary outcome measure AND with a positive MGA
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-lung-carcinoma
- nct id
- NCT00963911
- outcome key
- om-0001
- source section id
- NCT00963911-om-0001
- source outcome index
- 1
- endpoint
- Specificity of the G8 Questionnaire
- endpoint definition
- 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.
- time origin
- at inclusion (at completion of the G8 questionnaire)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Eligible patients assessable for the primary outcome measure AND with a negative MGA
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-lung-carcinoma
- nct id
- NCT00963911
- outcome key
- om-0002
- source section id
- NCT00963911-om-0002
- source outcome index
- 2
- endpoint
- Sensitivity of the VES-13 Questionnaire
- endpoint definition
- 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.
- time origin
- at inclusion
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Eligible Patients Assessable for the Primary Outcome Measure AND with a positive VES-13
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-lung-carcinoma
- nct id
- NCT00963911
- outcome key
- om-0003
- source section id
- NCT00963911-om-0003
- source outcome index
- 3
- endpoint
- Specificity of the VES-13 Questionnaire
- endpoint definition
- 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.
- time origin
- at inclusion (at completion of the G8 questionnaire)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Eligible patients assessable for the primary endpoint (sensitivity of the G8 questionnaire) and with a negative MGA
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-lung-carcinoma
- nct id
- NCT00963911
- outcome key
- om-0004
- source section id
- NCT00963911-om-0004
- source outcome index
- 4
- endpoint
- Reproducibility of the G8 Questionnaire
- endpoint definition
- 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.
- time origin
- at inclusion (at completion of the G8 questionnaire)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Eligible Patients Assessable for the Primary Outcome Measure AND with two assessments of the G8 available
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-lung-carcinoma
- nct id
- NCT00963911
- outcome key
- om-0005
- source section id
- NCT00963911-om-0005
- source outcome index
- 5
- endpoint
- Reproducibility of the VES-13 Questionnaire
- endpoint definition
- 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.
- time origin
- at inclusion (at completion of the G8 questionnaire)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Eligible Patients Assessable for the Primary Outcome Measure AND with two assessments of the VES-13 available
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-lung-carcinoma
- nct id
- NCT00963911
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Eligible Patients Assessable for the Primary Outcome Measure
- regimen
- Patients older than 70 years and included either before any first-line treatment, or between any two steps of a pre-defined first-line treatment sequence (chemotherapy, endocrine therapy, targeted treatment, surgery or radiotherapy) for various types of histologically-confirmed cancer (colon, lung, upper aero digestive tract (UAT)/head and neck, breast, prostate, and non-Hodgkin's lymphomas (NHL)), and for whom G8 as well as at least one instrument of the multidimensional assessment were available.
- analyzed count
- 1151
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00963911-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-lung-carcinoma
- nct id
- NCT00963911
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Eligible Patients Assessable for the Primary Outcome Measure
- regimen
- Patients older than 70 years and included either before any first-line treatment, or between any two steps of a pre-defined first-line treatment sequence (chemotherapy, endocrine therapy, targeted treatment, surgery or radiotherapy) for various types of histologically-confirmed cancer (colon, lung, upper aero digestive tract (UAT)/head and neck, breast, prostate, and non-Hodgkin's lymphomas (NHL)), and for whom G8 as well as at least one instrument of the multidimensional assessment were available.
- analyzed count
- 284
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00963911-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-lung-carcinoma
- nct id
- NCT00963911
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Eligible Patients Assessable for the Primary Outcome Measure
- regimen
- Patients older than 70 years and included either before any first-line treatment, or between any two steps of a pre-defined first-line treatment sequence (chemotherapy, endocrine therapy, targeted treatment, surgery or radiotherapy) for various types of histologically-confirmed cancer (colon, lung, upper aero digestive tract (UAT)/head and neck, breast, prostate, and non-Hodgkin's lymphomas (NHL)), and for whom G8 as well as at least one instrument of the multidimensional assessment were available.
- analyzed count
- 1151
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00963911-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-lung-carcinoma
- nct id
- NCT00963911
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Eligible Patients Assessable for the Primary Outcome Measure
- regimen
- Patients older than 70 years and included either before any first-line treatment, or between any two steps of a pre-defined first-line treatment sequence (chemotherapy, endocrine therapy, targeted treatment, surgery or radiotherapy) for various types of histologically-confirmed cancer (colon, lung, upper aero digestive tract (UAT)/head and neck, breast, prostate, and non-Hodgkin's lymphomas (NHL)), and for whom G8 as well as at least one instrument of the multidimensional assessment were available.
- analyzed count
- 284
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00963911-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-lung-carcinoma
- nct id
- NCT00963911
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Eligible Patients Assessable for the Primary Outcome Measure
- regimen
- Patients older than 70 years and included either before any first-line treatment, or between any two steps of a pre-defined first-line treatment sequence (chemotherapy, endocrine therapy, targeted treatment, surgery or radiotherapy) for various types of histologically-confirmed cancer (colon, lung, upper aero digestive tract (UAT)/head and neck, breast, prostate, and non-Hodgkin's lymphomas (NHL)), and for whom G8 as well as at least one instrument of the multidimensional assessment were available.
- analyzed count
- 1429
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00963911-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-lung-carcinoma
- nct id
- NCT00963911
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Eligible Patients Assessable for the Primary Outcome Measure
- regimen
- Patients older than 70 years and included either before any first-line treatment, or between any two steps of a pre-defined first-line treatment sequence (chemotherapy, endocrine therapy, targeted treatment, surgery or radiotherapy) for various types of histologically-confirmed cancer (colon, lung, upper aero digestive tract (UAT)/head and neck, breast, prostate, and non-Hodgkin's lymphomas (NHL)), and for whom G8 as well as at least one instrument of the multidimensional assessment were available.
- analyzed count
- 251
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00963911-om-0005#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-lung-carcinoma
- nct id
- NCT00963911
- harm key
- EG000
- source section id
- NCT00963911-ae
- event group key
- EG000
- event group label
- Included Patients
- serious affected
- 0
- serious at risk
- 1674
- other affected
- 0
- other at risk
- 1674
- frequency threshold
- 0
- collection period
- at baseline (at completion of the G8 questionnaire)
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice