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

Recruiting

• Conditions: Tumors

• Registration Number: NCT05733091
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

To learn about the symptoms and changes our patients experience while receiving treatment for sinonasal or nasopharyngeal cancer

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 Timeline

• Study Start: 2018-12-20
• Study First Submitted: 2023-02-08
• Study First Submitted QC: 2023-02-08
• Study First Posted: 2023-02-17
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-09
• Last Update Posted: 2025-05-14
• Primary Completion: 2029-12-31
• Study Completion: 2029-12-31

Recruitment & Eligibility

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

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
MD Anderson Symptom Inventory Head and Neck Module (MDASI-HN)	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)

Trial Locations

Locations (2)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States