Ignite Creation Date:
2024-05-05 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00417040
Status:
COMPLETED
Last Update Posted:
2017-06-27
First Post:
2006-12-27
Brief Title:
Collection of Patient-Reported Symptoms and Performance Status Via the Internet
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Collection of Patient-Reported Symptoms and Performance Status Via the Internet
Status:
COMPLETED
Status Verified Date:
2017-06
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 pilot clinical trial studies how well using the internet to collect symptoms and the ability to carry out daily activities works in patients with enrolled on Cancer and Leukemia Group B CALGB studies A study that evaluates a patients ability to use a clinic waiting room computer to report their symptoms and their ability to carry out daily activities may help doctors understand a patients use of a computer to report symptoms
Detailed Description:
This study enrolled participants who were diagnosed with breast cancer lung cancer colorectal cancer leukemia and multiple myeloma and prostate cancer
PRIMARY OBJECTIVES
I To assess the feasibility of collecting symptom data directly from patients at clinic visits via waiting-area computers
II To preliminarily assess the level of agreement between patient and clinician Common Terminology Criteria for Adverse Events CTCAE symptom severity scoring and to measure whether their scores converge when clinicians are exposed to patient self-reports
OUTLINE
Patients are registered into the Symptom Tracking and Reporting STAR database obtain a password undergo STAR training and complete a patient-STAR questionnaire after seeing their clinician baseline self-report on day 1 of course 2 of chemotherapy Patients are reminded to complete online STAR questionnaire before seeing their clinician on day 1 of courses 3 4 5 and 6 of chemotherapy Clinicians review these patient reports before creating their own assessment Patients also complete a patient feedback survey on day 1 of course 4 of chemotherapy Clinicians complete feedback survey at study completion
PRIMARY OBJECTIVES
I To assess the feasibility of collecting symptom data directly from patients at clinic visits via waiting-area computers
II To preliminarily assess the level of agreement between patient and clinician Common Terminology Criteria for Adverse Events CTCAE symptom severity scoring and to measure whether their scores converge when clinicians are exposed to patient self-reports
OUTLINE
Patients are registered into the Symptom Tracking and Reporting STAR database obtain a password undergo STAR training and complete a patient-STAR questionnaire after seeing their clinician baseline self-report on day 1 of course 2 of chemotherapy Patients are reminded to complete online STAR questionnaire before seeing their clinician on day 1 of courses 3 4 5 and 6 of chemotherapy Clinicians review these patient reports before creating their own assessment Patients also complete a patient feedback survey on day 1 of course 4 of chemotherapy Clinicians complete feedback survey at study completion
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 |
|---|---|---|---|
| U10CA037447 | NIH | NCI Clinical Trial Reporting Program | httpsreporternihgovquickSearchU10CA037447 |
| CDR0000521898 | REGISTRY | None | None |
| NCI-2009-00489 | REGISTRY | None | None |
| UG1CA189823 | NIH | None | None |