Assessment of Functional and Symptom Outcomes for Survivors of Paranasal Sinus, Nasopharyngeal and Skull Base Tumors

April 22, 2024 updated by: M.D. Anderson Cancer Center
To learn about the symptoms and changes our patients experience while receiving treatment for sinonasal or nasopharyngeal cancer

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Objectives:

  • To estimate the prevalence and severity of adverse and functional outcomes in survivors of benign and malignant paranasal sinus, nasopharynx and skull base tumors.
  • To estimate the prevalence of health promotion behaviors during skull base tumor survivorship
  • To identify possible mediators or predictors of survivorship outcomes and health behaviors in survivors of skull base tumors.
  • To develop a database of demographic, clinicopathologic, recurrence, survival, functional and patient reported outcomes (PROS) for patients with benign and malignant paranasal sinus, nasopharyngeal and skull base tumors.
  • To assess the utility and limitations of PROs in evaluating functional impairments and symptom burden in skull base patients.

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
        • Recruiting
        • M D Anderson Cancer Center
        • Contact:
        • Principal Investigator:
          • Shirley Su, MBBS

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

M D Anderson Cancer Center

Description

Inclusion criteria:

  1. Previously untreated patients with or suspected to have sinonasal malignancy or nasopharyngeal malignancy diagnosis based on either outside pathology report or MD Anderson pathology report.
  2. Age ≥ 18 years
  3. Plan to obtain the majority of treatment at MDACC including surgery and radiotherapy
  4. Ability to understand and willingness to sign written informed consent

Exclusion criteria:

  1. History of the previous solid or liquid malignancies, apart from skin cancers treated with local therapy.
  2. Existing neurocognitive impairment that is not the result of sinonasal and nasopharyngeal cancers or is treatment.
  3. Previous treatment for sinonasal or nasopharyngeal carcinomas, apart from biopsy.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MD Anderson Symptom Inventory Head and Neck Module (MDASI-HN)
Time Frame: through study completion; an average of 1 year

MD Anderson Symptom Inventory Head and Neck Module (MDASI-HN) is a disease specific PRO instrument validated for patients with head and neck cancer. It is the most commonly utilized instrument in the head and neck cancer population, of which sinonasal and nasopharyngeal tumors are disease subsites.

Score scale from 0 (symptom has been present) to 10 (the symptom was as bad as you can imagine it could be)
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: Shirley Su, MBBS, 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 (Actual)

December 20, 2018

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

February 8, 2023

First Submitted That Met QC Criteria

February 8, 2023

First Posted (Actual)

February 17, 2023

Study Record Updates

Last Update Posted (Actual)

April 23, 2024

Last Update Submitted That Met QC Criteria

April 22, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PA18-0969
  • NCI-2023-01436 (Other Identifier: NCI-CTRP Clinical Trials 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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