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NCT04874493 Clinical Trial

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

Oropharyngeal Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04874493
Other study ID # 2021-0015
Secondary ID NCI-2021-0324520
Status Recruiting
Phase
First received
Last updated
Start date March 10, 2021
Est. completion date February 2, 2027

Study information
Verified date February 2024
Source M.D. Anderson Cancer Center
Contact Xin S Wang, MD
Phone (713) 745-3504
Email xswang@mdanderson.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 77
Est. completion date February 2, 2027
Est. primary completion date February 2, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Electronic Health Record Review
Review of medical records
• Questionnaire Administration
Complete questionnaire

Locations
Country Name City State
United States M D Anderson Cancer Center Houston Texas

Sponsors (1)
Lead Sponsor Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Scores of symptoms on the MD Anderson Symptom Inventory - Head and Neck (MDASI-HN) relevant to toxicities 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. From the end of radiation therapy (RT)/chemoradiotherapy (CRT) treatment to 2 months post-treatment
See also
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Recruiting NCT04508829 - Anti-EGFR Therapy With IMRT Concurrent Chemoradiotherapy in Locally Advanced OPC Resistant to Induction Chemotherapy Phase 2
Completed NCT02365844 - Multispectral Imaging to Characterize Patterns of Vascular Supply Within Lymphoepithelial Mucosa in Oropharyngeal Cancer
Recruiting NCT05075980 - HEADLIGHT: Hypofractionated Proton Therapy for Head and Neck Cancers Phase 2
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Completed NCT01440270 - Neo-adjuvant Erbitux-based Chemotherapy for Locally Advanced Oral/Oropharyngeal Cancer Phase 2
Completed NCT01434394 - Neoadjuvant Erbitux Based Chemotherapy for Locally Advanced Oral/Oropharyngeal Cancer Phase 2/Phase 3

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