Sarcoma Treatment Guide in Improving Self-Monitoring in Patients With Sarcoma Receiving Chemotherapy
NCT ID: NCT03258892
Last Updated: 2022-09-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
64 participants
INTERVENTIONAL
2017-05-16
2020-12-15
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
NONE
Study Groups
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Arm A (STG pre-chemotherapy)
Patients receive the STG before completing 4 courses of standard of care chemotherapy.
Educational Intervention
Receive STG
Quality-of-Life Assessment
Ancillary studies
Survey Administration
Ancillary studies
Arm B (STG post-chemotherapy initiation)
Patients complete 2 courses of standard of care chemotherapy and then receive the STG before completing 2 additional courses of standard of care chemotherapy.
Educational Intervention
Receive STG
Quality-of-Life Assessment
Ancillary studies
Survey Administration
Ancillary studies
Interventions
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Educational Intervention
Receive STG
Quality-of-Life Assessment
Ancillary studies
Survey Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Sarcoma clinic patient
* About to begin either oral or cytotoxic chemotherapy
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Ohio State University Comprehensive Cancer Center
OTHER
Responsible Party
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James Chen
Principal Investigator
Principal Investigators
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James Chen, MD
Role: PRINCIPAL_INVESTIGATOR
Ohio State University Comprehensive Cancer Center
Locations
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Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Countries
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References
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Speece NJ, Xu M, Tinoco G, Liebner DA, Chen JL. Randomized Prospective Trial Exploring the Impact of Structured Journaling in Patients With Sarcoma on the Management of Treatment-Related Adverse Events. JCO Oncol Pract. 2022 Feb;18(2):e250-e260. doi: 10.1200/OP.21.00309. Epub 2021 Sep 24.
Related Links
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The Jamesline
Other Identifiers
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NCI-2017-01277
Identifier Type: REGISTRY
Identifier Source: secondary_id
OSU-16301
Identifier Type: -
Identifier Source: org_study_id
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