Assessment of Functional and Symptom Outcomes for Survivors of Paranasal Sinus, Nasopharyngeal and Skull Base Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Standard of Care.
- Who it may be relevant to
- Registry conditions: Tumors. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Behavioral Standard of Care
Standard of care assessment of their function including pituitary hormone lab draws, audiogram hearing test, eye exam, teeth and jaw exam (in trismus clinic) and speech and swallowing evaluation
Primary outcome measures
- MD Anderson Symptom Inventory Head and Neck Module (MDASI-HN) [Time frame: through study completion; an average of 1 year]
Eligibility criteria
Inclusion criteria
- 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.
- Age ≥ 18 years
- Plan to obtain the majority of treatment at MDACC including surgery and radiotherapy
- Ability to understand and willingness to sign written informed consent
Exclusion criteria
- History of the previous solid or liquid malignancies, apart from skin cancers treated with local therapy.
- Existing neurocognitive impairment that is not the result of sinonasal and nasopharyngeal cancers or is treatment.
- Previous treatment for sinonasal or nasopharyngeal carcinomas, apart from biopsy.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- M D Anderson Cancer Center — Houston
Identifiers
NCT: NCT05733091 · PA18-0969 · NCI-2023-01436