Prospective Evaluation of the Relation Between Different Questionnaires Measuring Radiation-induced Side-effect
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MDASI-HN, EORTC QLQ-C30, EORTC HN35.
- Who it may be relevant to
- Registry conditions: Radiation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed 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.
Interventions
- Other MDASI-HN
Given by Questionnaire - Other EORTC QLQ-C30
Given by Questionnaire - Other EORTC HN35
Given by Questionnaire
Primary outcome measures
- Safety and adverse events (AEs) [Time frame: Through study completion; an average of 1 year]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- MD Anderson Cancer Center — Houston
Identifiers
NCT: NCT06295783 · 2023-1059 · NCI-2024-01955