Breast Cancer, Colorectal Cancer, Head and Neck Cancer, Lung Cancer, Lymphoma, Prostate Cancer
Conditions
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
Brief 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.
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.
Interventions
OTHERGeriatric screening tests
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.
OTHERMultidimensional geriatric assessment
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).
Sponsors
National Cancer Institute, France
Institut Bergonié
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
70 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of the G8 Questionnaire | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Specificity of the G8 Questionnaire | at inclusion (at completion 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. |
| Sensitivity of the VES-13 Questionnaire | at inclusion | 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 | at inclusion (at completion of the G8 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. |
| Reproducibility of the G8 Questionnaire | at inclusion (at completion 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. |
| Reproducibility of the VES-13 Questionnaire | at inclusion (at completion of the G8 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. |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Eligible Patients 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)). | 1,597 |
| Total | 1,597 |
Baseline characteristics
| Characteristic | Eligible Patients |
|---|---|
| Age, Customized 70-74 years | 493 Participants |
| Age, Customized 75-79 years | 481 Participants |
| Age, Customized 80-84 years | 392 Participants |
| Age, Customized 85 years and older | 231 Participants |
| Region of Enrollment France | 1597 participants |
| Sex: Female, Male Female | 1110 Participants |
| Sex: Female, Male Male | 487 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 1,674 |
| other Total, other adverse events | 0 / 1,674 |
| serious Total, serious adverse events | 0 / 1,674 |
Outcome results
Primary
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.
Time frame: at inclusion (at completion of the G8 questionnaire)
Population: Eligible patients assessable for the primary outcome measure AND with a positive MGA
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Eligible Patients Assessable for the Primary Outcome Measure | Sensitivity of the G8 Questionnaire | 76.5 % of Participants with a positive G8 |
Secondary
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.
Time frame: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Eligible Patients Assessable for the Primary Outcome Measure | Reproducibility of the G8 Questionnaire | 0.65 Kappa coefficient of correlation |
Secondary
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.
Time frame: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Eligible Patients Assessable for the Primary Outcome Measure | Reproducibility of the VES-13 Questionnaire | 0.64 Kappa coefficient of correlation |
Secondary
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.
Time frame: at inclusion
Population: Eligible Patients Assessable for the Primary Outcome Measure AND with a positive VES-13
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Eligible Patients Assessable for the Primary Outcome Measure | Sensitivity of the VES-13 Questionnaire | 68.7 % of Participants with a positive VES13 |
Secondary
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.
Time frame: at inclusion (at completion of the G8 questionnaire)
Population: Eligible patients assessable for the primary outcome measure AND with a negative MGA
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Eligible Patients Assessable for the Primary Outcome Measure | Specificity of the G8 Questionnaire | 64.4 % of Participants with a negative G8 |
Secondary
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.
Time frame: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Eligible Patients Assessable for the Primary Outcome Measure | Specificity of the VES-13 Questionnaire | 74.3 % of Participants with a negative VES13 |