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

• Sponsor: M.D. Anderson Cancer Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04874493
• Collaborator: (none)
• Enrollment: 77
• Location: 1
• Anticipated Duration (Months): 21.7
• Patients Per Site Per Month: 3.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Oropharyngeal Carcinoma	Other: Electronic Health Record Review; Other: Questionnaire Administration

Detailed Description

PRIMARY OBJECTIVE:

1. 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 Design

• Study Type: Observational
• Anticipated Enrollment: 77 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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
• Actual Study Start Date: Mar 10, 2021
• Anticipated Primary Completion Date: Dec 31, 2022
• Anticipated Study Completion Date: Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Observational (questionnaire) 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.	Other: Electronic Health Record Review; Review of medical records; Other: Questionnaire Administration; Complete questionnaire

Outcome Measures

Primary Outcome Measures

1. 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]

Eligibility Criteria

Criteria

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

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

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: Tito R Mendoza, M.D. Anderson Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: M.D. Anderson Cancer Center
• ClinicalTrials.gov Identifier: NCT04874493
• Other Study ID Numbers: 2021-0015; NCI-2021-03245; 2021-0015
• First Posted: May 5, 2021
• Last Update Posted: May 5, 2021
• Last Verified: May 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Oropharyngeal Neoplasms

Study Results

No Results Posted as of May 5, 2021