Ignite Creation Date:
2025-12-24 @ 3:42 PM
Ignite Modification Date:
2026-02-20 @ 3:31 PM
Study NCT ID:
NCT03258892
Status:
COMPLETED
Last Update Posted:
2022-09-28
First Post:
2017-08-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sarcoma Treatment Guide in Improving Self-Monitoring in Patients With Sarcoma Receiving Chemotherapy
Sponsor:
Ohio State University Comprehensive Cancer Center
Organization:
Study Overview
Official Title:
Sarcoma Treatment Guide Pilot Study
Status:
COMPLETED
Status Verified Date:
2022-09
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 randomized pilot clinical trial studies how well the Sarcoma Treatment Guide works in improving self-monitoring in patients with sarcoma who are receiving chemotherapy. The Sarcoma Treatment Guide may help patients with sarcoma to be better informed, become more engaged with care, encourage communication, and to better manage side effects associated with chemotherapy treatments in order to improve quality of life.
Detailed Description:
PRIMARY OBJECTIVES:
I. To evaluate whether symptom management and communication are improved in patients who are chemotherapy naive who receive a Sarcoma Treatment Guide as compared to those that have not.
SECONDARY OBJECTIVES:
I. To explore whether patients who have previously undergone chemotherapy benefit from a Sarcoma Treatment Guide (STG) in regard to symptom management and have improved communication between patient and providers.
II. To assess patient satisfaction with using the STG at the end of the trial.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients receive the STG before completing 4 courses of standard of care chemotherapy.
ARM B: Patients complete 2 courses of standard of care chemotherapy and then receive the STG before completing 2 additional courses of standard of care chemotherapy.
I. To evaluate whether symptom management and communication are improved in patients who are chemotherapy naive who receive a Sarcoma Treatment Guide as compared to those that have not.
SECONDARY OBJECTIVES:
I. To explore whether patients who have previously undergone chemotherapy benefit from a Sarcoma Treatment Guide (STG) in regard to symptom management and have improved communication between patient and providers.
II. To assess patient satisfaction with using the STG at the end of the trial.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients receive the STG before completing 4 courses of standard of care chemotherapy.
ARM B: Patients complete 2 courses of standard of care chemotherapy and then receive the STG before completing 2 additional courses of standard of care chemotherapy.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2017-01277 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View |