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

Sponsor
M.D. Anderson Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05733091
Collaborator
(none)
300
1
72.4
4.1

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Standard of Care

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
Anticipated Enrollment :
300 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Assessment of Functional and Symptom Outcomes for Survivors of Paranasal Sinus, Nasopharyngeal and Skull Base Tumors
Actual Study Start Date :
Dec 20, 2018
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Outcome Measures

Primary Outcome Measures

  1. 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 M D Anderson Cancer Center Houston Texas United States 77030

Sponsors and Collaborators

  • M.D. Anderson Cancer Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT05733091
Other Study ID Numbers:
  • PA18-0969
  • NCI-2023-01436
First Posted:
Feb 17, 2023
Last Update Posted:
Feb 17, 2023
Last Verified:
Feb 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 17, 2023