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Clinical Trials/NCT04874493
NCT04874493
Active, not recruiting
Not Applicable

A Pilot Study to Define PROs for Establishing a Pathway for Post Radiation or Concurrent Chemo Radiation (RT/CRT) Patient Care for Oropharyngeal Cancer

M.D. Anderson Cancer Center1 site in 1 country77 target enrollmentMarch 10, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Oropharyngeal Carcinoma
Sponsor
M.D. Anderson Cancer Center
Enrollment
77
Locations
1
Primary Endpoint
Scores of symptoms on the MD Anderson Symptom Inventory - Head and Neck (MDASI-HN) relevant to toxicities
Status
Active, not recruiting
Last Updated
3 months ago

Overview

Brief Summary

This study examines patient reported outcomes post radiation therapy or chemoradiotherapy patient care in patients with oropharyngeal cancer. This study may help researchers learn about the symptoms that patients with oropharyngeal cancer have after completing radiation therapy.

Detailed Description

PRIMARY OBJECTIVE: I. To provide evidence of clinically relevant symptoms for integrating into a user-friendly, automated pathway for real-time tracking and management of symptoms during post radiation therapy (RT)/chemoradiation (CRT) for oropharyngeal cancer (OPC). OUTLINE: Patients complete questionnaire over 10-20 minutes at baseline, 2 times every week during weeks 1-8 of radiation therapy, and at the end of the study.

Registry
clinicaltrials.gov
Start Date
March 10, 2021
End Date
February 2, 2027
Last Updated
3 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients who were seen for new patient evaluation at clinics and HNC centers at MD Anderson Cancer Center
  • Adult patients with OPC (\> 18 years old) who have been enrolled under PA14-0947

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Scores of symptoms on the MD Anderson Symptom Inventory - Head and Neck (MDASI-HN) relevant to toxicities

Time Frame: From the end of radiation therapy (RT)/chemoradiotherapy (CRT) treatment to 2 months post-treatment

All symptom PRO items on MDASI-HN (MD Anderson Symptom Inventory - Head and Neck (MDASI) would be rated by patients on 0 -10 of severity scale, with 0 being no symptom, and 10 being symptom as bas as imagine.

Study Sites (1)

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