Validation of a Screening Tool in Geriatric Oncology

NCT00963911 | Completed Results DMC

• 3 other identifiers: IB 2008-06IB-ONCODAGE2008-A00322-53
• Study Type: interventional
• Target: 1,674
• Locations: 1 country
• Sites: 1

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.

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; 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Specificity of the G8 Questionnaire

  at inclusion (at completion of the G8 questionnaire)

• Sensitivity of the VES-13 Questionnaire

  at inclusion

• Specificity of the VES-13 Questionnaire

  at inclusion (at completion of the G8 questionnaire)

• Reproducibility of the G8 Questionnaire

  at inclusion (at completion of the G8 questionnaire)

• Reproducibility of the VES-13 Questionnaire

  at inclusion (at completion of the G8 questionnaire)

Study Arms (1)

Included patients

EXPERIMENTAL

Screening tests (G8 and VES-13)

Other: Geriatric screening tests; Other: Multidimensional geriatric assessment

Interventions

Geriatric screening tests OTHER

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.

Also known as: G-8

Included patients

Multidimensional geriatric assessment OTHER

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).

Also known as: MGA

Included patients

Eligibility Criteria

• Age: 70 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Institut Bergonié: lead
• National Cancer Institute, France: collaborator

Study Sites (1)

Institut Bergonie

Bordeaux, 33076, France

Location

Related Publications (2)

• 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.

  PMID: 28327973 BACKGROUND

• Soubeyran 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.

  PMID: 25503576 RESULT

MeSH Terms

Conditions

Breast Neoplasms; Colorectal Neoplasms; Head and Neck Neoplasms; Lung Neoplasms; Lymphoma; Prostatic Neoplasms; Colonic Neoplasms; Rectal Neoplasms; Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma; Squamous Cell Carcinoma of Head and Neck; Lymphoid Interstitial Pneumonia; Lymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial

Results Point of Contact

• Title: Pr Pierre Soubeyran
• Organization: Institut Bergonié

p.soubeyran@bordeaux.unicancer.fr

33(0)556333333

Study Officials

• Pierre Soubeyran, MD, PhD

  Institut Bergonié

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2009
• First Posted: August 24, 2009
• Study Start: August 5, 2008
• Primary Completion: March 8, 2010
• Study Completion: March 8, 2015
• Last Updated: April 5, 2021
• Results First Posted: January 26, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)