Ignite Creation Date:
2024-05-05 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00416481
Status:
COMPLETED
Last Update Posted:
2016-07-13
First Post:
2006-12-27
Brief Title:
Assessing Older Patients With Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Development of a Geriatric Assessment Measure for Older Patients With Cancer
Status:
COMPLETED
Status Verified Date:
2016-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Questionnaires that measure the ability of older patients to think learn remember and make judgments and carry out daily activities may improve the ability to plan treatment for patients with cancer
PURPOSE This clinical trial is studying ways to assess older patients with cancer
PURPOSE This clinical trial is studying ways to assess older patients with cancer
Detailed Description:
OBJECTIVES
Primary
Determine the feasibility of administration of the geriatric assessment in elderly patients with cancer
Determine the percentage of patients able to complete the self-administered portion of the geriatric assessment without assistance
Determine the length of time necessary to complete the geriatric assessment
Determine the variance and number of missing items
Assess patient satisfaction with the questionnaire by identifying items that are distressing or difficult to comprehend
Assess the percentage of geriatric assessments that contain all three of the following items Timed Up and Go Assessment Blessed Orientation-Memory-Concentration Test and healthcare professional-rated Karnofsky performance status
Secondary
Determine the proportion of patients who are able to complete the self-report portion of the questionnaire without assistance and the length of time needed to complete the geriatric assessment within patients of various sociodemographic factors and educational status
OUTLINE This is a multicenter study Patients are stratified according to age 65 to 69 years vs 70 years and over
Patients undergo assessments of cognition using the Blessed Orientation-Memory-Concentration Test functional status using the Timed Up and Go Assessment measures physical mobility and performance status using the healthcare professional-rated Karnofsky performance scale These assessments are performed by healthcare personnel Body mass index and the percentage of unintentional weight loss and the number of falls in the past 6 months are also assessed
Patients also complete the following self-administered questionnaires Instrumental Activities of Daily Living measures level of functioning and need for services Activities of Daily Living measures higher levels of physical functioning Karnofsky Self-Reported Performance Rating Scale related to survival and clinically significant illness Physical Health Section of the Older American Resources and Services Questionnaire measures comorbidity and the impact on daily activities Hospital Anxiety and Depression Scale Medical Outcomes Study MOS Social Activity Limitations Measure measures the impact of cancer on patients social functioning and MOS Social Support Survey EmotionalInformation and Tangible Subscales measures perceived availability of social support
Patients then begin planned treatment
Primary
Determine the feasibility of administration of the geriatric assessment in elderly patients with cancer
Determine the percentage of patients able to complete the self-administered portion of the geriatric assessment without assistance
Determine the length of time necessary to complete the geriatric assessment
Determine the variance and number of missing items
Assess patient satisfaction with the questionnaire by identifying items that are distressing or difficult to comprehend
Assess the percentage of geriatric assessments that contain all three of the following items Timed Up and Go Assessment Blessed Orientation-Memory-Concentration Test and healthcare professional-rated Karnofsky performance status
Secondary
Determine the proportion of patients who are able to complete the self-report portion of the questionnaire without assistance and the length of time needed to complete the geriatric assessment within patients of various sociodemographic factors and educational status
OUTLINE This is a multicenter study Patients are stratified according to age 65 to 69 years vs 70 years and over
Patients undergo assessments of cognition using the Blessed Orientation-Memory-Concentration Test functional status using the Timed Up and Go Assessment measures physical mobility and performance status using the healthcare professional-rated Karnofsky performance scale These assessments are performed by healthcare personnel Body mass index and the percentage of unintentional weight loss and the number of falls in the past 6 months are also assessed
Patients also complete the following self-administered questionnaires Instrumental Activities of Daily Living measures level of functioning and need for services Activities of Daily Living measures higher levels of physical functioning Karnofsky Self-Reported Performance Rating Scale related to survival and clinically significant illness Physical Health Section of the Older American Resources and Services Questionnaire measures comorbidity and the impact on daily activities Hospital Anxiety and Depression Scale Medical Outcomes Study MOS Social Activity Limitations Measure measures the impact of cancer on patients social functioning and MOS Social Support Survey EmotionalInformation and Tangible Subscales measures perceived availability of social support
Patients then begin planned treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000523527 | REGISTRY | NCI Physician Data Query | None |
| CALGB-360401 | None | None | None |