Ignite Creation Date:
2024-05-05 @ 6:34 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00505245
Status:
RECRUITING
Last Update Posted:
2024-07-05
First Post:
2007-07-19
Brief Title:
New Assessment System in Measuring Symptom Distress in Cancer Patients
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Measuring the Symptom Distress of Cancer Patients Development of a New Assessment System
Status:
RECRUITING
Status Verified Date:
2024-06
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:
This trial studies how well a new assessment system MDASI or other MD Anderson-developed PRO instrument works in measuring symptoms and the impact on quality of life in cancer patients Development of a new assessment system may provide more information about the common symptoms that may occur in patients due to cancer and its treatment and how the symptoms impact quality of life
Detailed Description:
PRIMARY OBJECTIVES
I To examine how the MD Anderson Inventory MD Anderson Symptom Inventory MDASI or other MD Anderson-developed patient reported outcome PRO instrument performs in various sample populations including community dwelling adults and patients who have different cancer types who have undergone various treatments and who have different andor more severe symptoms
II To evaluate the MDASI or other MD Anderson-developed PRO instrument as an estimate of functional status and quality of life
III To assess the impact of symptom severity on standard function and health-related quality of life measures including both quantitative and qualitative measures patient interviews
IV To assess the pattern and severity of symptoms over multiple time points in order to assay the systems responsiveness to changes due to therapy or disease
V To explore the utility of an interactive voice response IVR system in enhancing the clinical care of outpatients
VI To explore the effect of information from an IVR symptom assessment system on the pattern of care and development of interdisciplinary protocols
VII To explore the feasibility of developing symptom management pathways for patients based on these symptom and quality of life data
OUTLINE
Participants complete questionnaires and quality of life assessments and may also complete interviews over 45 minutes periodically
I To examine how the MD Anderson Inventory MD Anderson Symptom Inventory MDASI or other MD Anderson-developed patient reported outcome PRO instrument performs in various sample populations including community dwelling adults and patients who have different cancer types who have undergone various treatments and who have different andor more severe symptoms
II To evaluate the MDASI or other MD Anderson-developed PRO instrument as an estimate of functional status and quality of life
III To assess the impact of symptom severity on standard function and health-related quality of life measures including both quantitative and qualitative measures patient interviews
IV To assess the pattern and severity of symptoms over multiple time points in order to assay the systems responsiveness to changes due to therapy or disease
V To explore the utility of an interactive voice response IVR system in enhancing the clinical care of outpatients
VI To explore the effect of information from an IVR symptom assessment system on the pattern of care and development of interdisciplinary protocols
VII To explore the feasibility of developing symptom management pathways for patients based on these symptom and quality of life data
OUTLINE
Participants complete questionnaires and quality of life assessments and may also complete interviews over 45 minutes periodically
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| R01CA205146 | NIH | M D Anderson Cancer Center | httpsreporternihgovquickSearchR01CA205146 |
| NCI-2018-02461 | REGISTRY | None | None |
| BS99-094 | OTHER | None | None |
| P30CA016672 | NIH | None | None |