NCT04874493

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77

participants targeted

Target at P50-P75 for all trials

Timeline
9mo left

Started Mar 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress87%
Mar 2021Feb 2027

Study Start

First participant enrolled

March 10, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 2, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 5, 2021

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2027

Last Updated

January 14, 2026

Status Verified

January 1, 2026

Enrollment Period

5.9 years

First QC Date

May 2, 2021

Last Update Submit

January 13, 2026

Conditions

Oropharyngeal Carcinoma

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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 ReviewOther: Questionnaire Administration

Interventions

Electronic Health Record ReviewOTHER

Review of medical records

Observational (questionnaire)
Questionnaire AdministrationOTHER

Complete questionnaire

Observational (questionnaire)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with OPC who were seen for new patient evaluation at clinics and head and neck cancer (HNC) centers at MD Anderson Cancer Center

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Oropharyngeal Neoplasms

Condition Hierarchy (Ancestors)

Pharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNeoplasmsPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Xin S Wang, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2021

First Posted

May 5, 2021

Study Start

March 10, 2021

Primary Completion (Estimated)

February 2, 2027

Study Completion (Estimated)

February 2, 2027

Last Updated

January 14, 2026

Record last verified: 2026-01

Locations

US(1)