Trial Outcomes & Findings for Validation of a Screening Tool in Geriatric Oncology (NCT NCT00963911)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

1674 participants

Primary outcome timeframe

at inclusion (at completion of the G8 questionnaire)

Results posted on

2021-04-05

Participant Flow

Participant milestones

Participant milestones
Measure	Included Patients Patients older than 70 years
Overall Study STARTED	1674
Overall Study COMPLETED	1674
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Validation of a Screening Tool in Geriatric Oncology

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Eligible Patients n=1597 Participants Patients older than 70 years and were 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)).
Age, Customized 70-74 years	493 Participants n=5 Participants
Age, Customized 75-79 years	481 Participants n=5 Participants
Age, Customized 80-84 years	392 Participants n=5 Participants
Age, Customized 85 years and older	231 Participants n=5 Participants
Sex: Female, Male Female	1110 Participants n=5 Participants
Sex: Female, Male Male	487 Participants n=5 Participants
Region of Enrollment France	1597 participants n=5 Participants

PRIMARY outcome

Timeframe: at inclusion (at completion of the G8 questionnaire)

Population: Eligible patients assessable for the primary outcome measure AND with a positive MGA

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.

Outcome measures

Outcome measures
Measure	Eligible Patients Assessable for the Primary Outcome Measure n=1151 Participants 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.
Sensitivity of the G8 Questionnaire	76.5 % of Participants with a positive G8 Interval 73.9 to 78.9

SECONDARY outcome

Timeframe: at inclusion (at completion of the G8 questionnaire)

Population: Eligible patients assessable for the primary outcome measure AND with a negative MGA

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.

Outcome measures

Outcome measures
Measure	Eligible Patients Assessable for the Primary Outcome Measure n=284 Participants 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.
Specificity of the G8 Questionnaire	64.4 % of Participants with a negative G8 Interval 58.6 to 70.0

SECONDARY outcome

Timeframe: at inclusion

Population: Eligible Patients Assessable for the Primary Outcome Measure AND with a positive VES-13

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.

Outcome measures

Outcome measures
Measure	Eligible Patients Assessable for the Primary Outcome Measure n=1151 Participants 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.
Sensitivity of the VES-13 Questionnaire	68.7 % of Participants with a positive VES13 Interval 66.0 to 71.4

SECONDARY outcome

Timeframe: at inclusion (at completion of the G8 questionnaire)

Population: Eligible patients assessable for the primary endpoint (sensitivity of the G8 questionnaire) and with a negative MGA

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.

Outcome measures

Outcome measures
Measure	Eligible Patients Assessable for the Primary Outcome Measure n=284 Participants 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.
Specificity of the VES-13 Questionnaire	74.3 % of Participants with a negative VES13 Interval 68.8 to 79.3

SECONDARY outcome

Timeframe: at inclusion (at completion of the G8 questionnaire)

Population: Eligible Patients Assessable for the Primary Outcome Measure AND with two assessments of the G8 available

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.

Outcome measures

Outcome measures
Measure	Eligible Patients Assessable for the Primary Outcome Measure n=1429 Participants 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.
Reproducibility of the G8 Questionnaire	0.65 Kappa coefficient of correlation Interval 0.61 to 0.7

SECONDARY outcome

Timeframe: at inclusion (at completion of the G8 questionnaire)

Population: Eligible Patients Assessable for the Primary Outcome Measure AND with two assessments of the VES-13 available

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.

Outcome measures

Outcome measures
Measure	Eligible Patients Assessable for the Primary Outcome Measure n=251 Participants 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.
Reproducibility of the VES-13 Questionnaire	0.64 Kappa coefficient of correlation Interval 0.54 to 0.73

Adverse Events

Included Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Pr Pierre Soubeyran

Institut Bergonié

Phone: 33(0)556333333

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place