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Trial Title:
Assessment of Functional and Symptom Outcomes for Survivors of Paranasal Sinus, Nasopharyngeal and Skull Base Tumors
NCT ID:
NCT05733091
Condition:
Tumors
Conditions: Official terms:
Skull Base Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Behavioral
Intervention name:
Standard of Care
Description:
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
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.
Criteria for eligibility:
Study pop:
M D Anderson Cancer Center
Sampling method:
Probability Sample
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
M D Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Shirley Su, MBBS
Phone:
(713) 792-4720
Email:
sysu@mdanderson.org
Contact backup:
Last name:
Shirley Su, MBBS
Start date:
December 20, 2018
Completion date:
December 31, 2029
Lead sponsor:
Agency:
M.D. Anderson Cancer Center
Agency class:
Other
Source:
M.D. Anderson Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05733091
http://www.mdanderson.org
