Validation of a Screening Tool in Geriatric Oncology

Breast Cancer Clinical Trial

— ONCODAGE  

Official title:

Validation of a Screening Tool in Geriatric Oncology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00963911
• Other study ID #: IB 2008-06
• Secondary ID: IB-ONCODAGEIB 20
• Status: Completed
• Phase: N/A
• Start date: August 5, 2008
• Est. completion date: March 8, 2015

Study information

• Verified date: March 2021
• Source: Institut Bergonié
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1674
• Est. completion date: March 8, 2015
• Est. primary completion date: March 8, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Colorectal Cancer
• Head and Neck Cancer
• Lung Cancer
• Lung Neoplasms
• Lymphoma
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• Geriatric 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.
• Multidimensional 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).

Locations

Country	Name	City	State
France	Institut Bergonie	Bordeaux

Sponsors (2)

Lead Sponsor	Collaborator
Institut Bergonié	National Cancer Institute, France

Country where clinical trial is conducted

France, 

References & Publications (2)

Bellera CA, Artaud F, Rainfray M, Soubeyran PL, Mathoulin-Pélissier 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. — View Citation

Soubeyran P, Bellera C, Goyard J, Heitz D, Curé H, Rousselot H, Albrand G, Servent V, Jean OS, van Praagh I, Kurtz JE, Périn S, Verhaeghe JL, Terret C, Desauw C, Girre V, Mertens C, Mathoulin-Pélissier S, Rainfray M. Screening for vulnerability in older c — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	at inclusion (at completion of the G8 questionnaire)
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.	at inclusion (at completion of the G8 questionnaire)
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.	at inclusion
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.	at inclusion (at completion of the G8 questionnaire)
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.	at inclusion (at completion of the G8 questionnaire)
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.	at inclusion (at completion of the G8 questionnaire)