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

February 29, 2024 updated by: M.D. Anderson Cancer Center
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center
        • Contact:
        • Principal Investigator:
          • Amy Moreno, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Head and Neck Cancer (HNC) participants undergoing active radiation therapy.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: MDASI-HN
Given by Questionnaire
Other: EORTC QLQ-C30
Given by Questionnaire
Other: EORTC HN35
Given by Questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and adverse events (AEs)
Time Frame: 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)
Through study completion; an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Amy Moreno, MD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 31, 2024

Primary Completion (Estimated)

February 1, 2025

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

February 29, 2024

First Submitted That Met QC Criteria

February 29, 2024

First Posted (Estimated)

March 6, 2024

Study Record Updates

Last Update Posted (Estimated)

March 6, 2024

Last Update Submitted That Met QC Criteria

February 29, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 2023-1059
  • NCI-2024-01955 (Other Identifier: NCI-CTRP Clinical Registry)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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