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

Recruiting

• Conditions: Radiation
• Interventions: Other: MDASI-HN; Other: EORTC QLQ-C30; Other: EORTC HN35

• Registration Number: NCT06295783
• Lead Sponsor: M.D. Anderson Cancer Center

Brief 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.

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.

Study Timeline

• Study First Submitted: 2024-02-29
• Study First Submitted QC: 2024-02-29
• Study First Posted: 2024-03-06
• Study Start: 2024-06-10
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-07
• Last Update Posted: 2025-01-09
• Primary Completion: 2025-02-01
• Study Completion: 2027-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Head and Neck Cancer (HNC) Questionnaire	MDASI-HN	Participants will be asked to fill out three head and neck cancer (HNC) questionnaires during your visits to the clinic: 1. The MDASI-HN questionnaire (standard-of-care) has 28 questions. 2. The EORTC QLQ-HN35 questionnaire has 35 questions. 3. The EORTC QLQ-30 questionnaire has 30 questions.
Head and Neck Cancer (HNC) Questionnaire	EORTC HN35	Participants will be asked to fill out three head and neck cancer (HNC) questionnaires during your visits to the clinic: 1. The MDASI-HN questionnaire (standard-of-care) has 28 questions. 2. The EORTC QLQ-HN35 questionnaire has 35 questions. 3. The EORTC QLQ-30 questionnaire has 30 questions.
Head and Neck Cancer (HNC) Questionnaire	EORTC QLQ-C30	Participants will be asked to fill out three head and neck cancer (HNC) questionnaires during your visits to the clinic: 1. The MDASI-HN questionnaire (standard-of-care) has 28 questions. 2. The EORTC QLQ-HN35 questionnaire has 35 questions. 3. The EORTC QLQ-30 questionnaire has 30 questions.

Primary Outcome Measures

Name	Time	Method
Safety and adverse events (AEs)	Through study completion; an average of 1 year	Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)

Trial Locations

Locations (1)

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States