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

NCT ID: NCT06295783

Last Updated: 2026-01-14

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-10

Study Completion Date

2027-02-01

Brief Summary

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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

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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.

Conditions

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Radiation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

MDASI-HN

Intervention Type OTHER

Given by Questionnaire

EORTC QLQ-C30

Intervention Type OTHER

Given by Questionnaire

EORTC HN35

Intervention Type OTHER

Given by Questionnaire

Interventions

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MDASI-HN

Given by Questionnaire

Intervention Type OTHER

EORTC QLQ-C30

Given by Questionnaire

Intervention Type OTHER

EORTC HN35

Given by Questionnaire

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Amy Moreno, MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

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MD Anderson Cancer Center

Houston, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Amy Moreno, MD

Role: CONTACT

(713) 745-4590

Facility Contacts

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Amy Moreno, MD

Role: primary

713-745-4590

Related Links

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http://www.mdanderson.org

MD Anderson Cancer Center

Other Identifiers

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NCI-2024-01955

Identifier Type: OTHER

Identifier Source: secondary_id

2023-1059

Identifier Type: -

Identifier Source: org_study_id

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