NCT05733091
Recruiting
Not Applicable
Assessment of Functional and Symptom Outcomes for Survivors of Paranasal Sinus, Nasopharyngeal and Skull Base Tumors
M.D. Anderson Cancer Center2 sites in 1 country300 target enrollmentStarted: December 20, 2018Last updated:
ConditionsTumors
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- M.D. Anderson Cancer Center
- Enrollment
- 300
- Locations
- 2
- Primary Endpoint
- MD Anderson Symptom Inventory Head and Neck Module (MDASI-HN)
Overview
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
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)
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
Loading locations...
Similar Trials
Completed
Phase 3
Effect of Pantoprazole on the Symptoms of Acid Reflux Disease in Adult Patients (BY1023/M3-341)Gastroesophageal Reflux Disease (GERD)NCT00312806Takeda2,000
Completed
Not Applicable
Assessment of Symptoms and Consequences of Coloanal Continuity ReconstructionRectal CancerNCT03292289Centre Oscar Lambret65
Unknown
Not Applicable
Quality of Life, Symptoms and Treatment Satisfaction in Adult Patients With Relapsed and/or Refractory Multiple Myeloma, Receiving Ixazomib (Ninlaro®) in Combination With Lenalidomide and Dexamethasone in a Real World Setting: Pilot StudyRelapsed and/or Refractory Multiple MyelomaNCT03903406Multinational Center for Quality of Life Research, Russia40
Recruiting
Not Applicable
RFA of Benign Thyroid Nodules: Clinical Outcomes and Quality of Life StudyThyroid NodulesNCT05189314Columbia University100
Completed
Not Applicable
Patient-Reported Outcomes in Adults With Congenital Heart DiseaseHeart Defects, CongenitalNCT02150603Philip Moons4,000