Prospective Evaluation of the Relation Between Different Questionnaires Measuring Radiation-induced Side-effect
2 other identifiers
observational
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2024
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 29, 2024
CompletedFirst Posted
Study publicly available on registry
March 6, 2024
CompletedStudy Start
First participant enrolled
June 10, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2027
ExpectedJanuary 14, 2026
January 1, 2026
1.6 years
February 29, 2024
January 13, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Head and Neck Cancer (HNC) Questionnaire
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.
Interventions
Eligibility Criteria
Head and Neck Cancer (HNC) participants undergoing active radiation therapy.
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
Amy Moreno, MD
M.D. Anderson Cancer Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 29, 2024
First Posted
March 6, 2024
Study Start
June 10, 2024
Primary Completion
February 1, 2026
Study Completion (Estimated)
February 1, 2027
Last Updated
January 14, 2026
Record last verified: 2026-01