Patient Reported Outcome Post Radiation Therapy or Chemoradiotherapy Patient Care in Patients With Oropharyngeal Cancer

Active, not recruiting

• Conditions: Oropharyngeal Carcinoma
• Interventions: Other: Electronic Health Record Review; Other: Questionnaire Administration

• Registration Number: NCT04874493
• Lead Sponsor: M.D. Anderson Cancer Center

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.

Study Timeline

• Study Start: 2021-03-10
• Study First Submitted: 2021-05-02
• Study First Submitted QC: 2021-05-02
• Study First Posted: 2021-05-05
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-24
• Last Update Posted: 2024-07-26
• Primary Completion: 2027-02-02
• Study Completion: 2027-02-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 77

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational (questionnaire)	Electronic Health Record Review	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.
Observational (questionnaire)	Questionnaire Administration	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States