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NCT06295783 Clinical Trial

Prospective Evaluation of the Relation Between Different Questionnaires Measuring Radiation-induced Side-effect

Radiation Clinical Trial

Official title:
Prospective Evaluation of the Relation Between Different Questionnaires Measuring Radiation-induced Side-effect

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06295783
Other study ID # 2023-1059
Secondary ID NCI-2024-01955
Status Not yet recruiting
Phase
First received
Last updated
Start date August 31, 2024
Est. completion date February 1, 2027

Study information
Verified date February 2024
Source M.D. Anderson Cancer Center
Contact Amy Moreno, MD
Phone (713) 745-4590
Email akmoreno@mdanderson.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To learn more about how you would rate the intensity or severity of your symptoms during or after radiation therapy using questionnaires with different rating scales.

Description:

Primary Objectives: • To investigate how different toxicity questionnaires with different scoring systems can be reliably translated to each other by estimating different measures of correlation between items and summary scores across different questionnaires.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 300
Est. completion date February 1, 2027
Est. primary completion date February 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age =18 years - English as a primary language - Participants with a diagnosis of HNC undergoing active curative RT or having received curative RT within the past 5 years at MD Anderson - Ability to complete the survey(s) of their own volition Exclusion Criteria: - Age < 18 years - Non-English speaking participants - Participants who are receiving or have received RT in a non-HN site. - Participants in follow up and over 5 years from post-treatment - Neurocognitive deficits that render patients unable to complete the survey(s) on their own.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• MDASI-HN
Given by Questionnaire
• EORTC QLQ-C30
Given by Questionnaire
• EORTC HN35
Given by Questionnaire

Locations
Country Name City State
United States MD Anderson Cancer Center Houston Texas

Sponsors (1)
Lead Sponsor Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety and adverse events (AEs) Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Through study completion; an average of 1 year
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