Ignite Creation Date:
2024-05-05 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00477958
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-19
First Post:
2007-05-23
Brief Title:
Assessment Tool for Older Patients With Cancer
Sponsor:
City of Hope Medical Center
Organization:
City of Hope Medical Center
Study Overview
Official Title:
Determining the Utility of an Assessment Tool for Older Patients With Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-03
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 A study that assesses the ability of older patients to think learn remember make judgments and carry out daily activities may help doctors plan treatment for older patients with cancer
PURPOSE This clinical trial is studying an assessment tool in older patients with cancer
PURPOSE This clinical trial is studying an assessment tool in older patients with cancer
Detailed Description:
OBJECTIVES
Primary
Determine whether a geriatric assessment tool can predict toxicity to chemotherapy defined as grade 3 or 4 toxicity hospitalization dose delay or reduction or discontinuation of chemotherapy due to toxicity in elderly patients with cancer
Secondary
Explore the longitudinal impact of cancer and chemotherapy treatment on geriatric assessment parameters
OUTLINE Patients undergo assessments of functional status using the Timed Up and Go Assessment measures physical mobility and Karnofsky Physician-Rated Performance Rating Scale and cognition using the Blessed Orientation-Memory-Concentration Test 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 chemotherapy
After completion of chemotherapy or a maximum of 12 months from study entry patients undergo assessments and complete self-administered questionnaires as described above
PROJECTED ACCRUAL A total of 750 patients will be accrued for this study
Primary
Determine whether a geriatric assessment tool can predict toxicity to chemotherapy defined as grade 3 or 4 toxicity hospitalization dose delay or reduction or discontinuation of chemotherapy due to toxicity in elderly patients with cancer
Secondary
Explore the longitudinal impact of cancer and chemotherapy treatment on geriatric assessment parameters
OUTLINE Patients undergo assessments of functional status using the Timed Up and Go Assessment measures physical mobility and Karnofsky Physician-Rated Performance Rating Scale and cognition using the Blessed Orientation-Memory-Concentration Test 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 chemotherapy
After completion of chemotherapy or a maximum of 12 months from study entry patients undergo assessments and complete self-administered questionnaires as described above
PROJECTED ACCRUAL A total of 750 patients will be accrued for this study
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 |
|---|---|---|---|
| CDR0000540332 | REGISTRY | NCI PDQ | httpsreporternihgovquickSearchP30CA033572 |
| P30CA033572 | NIH | None | None |
| CHNMC-06170 | None | None | None |
| MSKCC-06034 | None | None | None |