Oropharyngeal CarcinomaNCT04874493
Patient Reported Outcome Post Radiation Therapy or Chemoradiotherapy Patient Care in Patients With Oropharyngeal Cancer
An observational study of Oropharyngeal Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oropharyngeal Carcinoma
- What is being tested?
- Electronic Health Record Review and Questionnaire Administration
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2021to 2 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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.
- Conditions
- Oropharyngeal Carcinoma
- Being tested
- Electronic Health Record Review, Questionnaire Administration
- Medical subject headings
- Oropharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic Health Record ReviewOther
Review of medical records
Questionnaire AdministrationOther
Complete questionnaire
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Electronic Health Record Review; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the end of radiation therapy (RT)/chemoradiotherapy (CRT) treatment to 2 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2021
- Study start10 Mar 2021
- Primary completion2 Feb 2027 (estimated)
- Study completion2 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oropharyngeal CarcinomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xin S Wang, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04874493
- Sponsor's protocol ID
- 2021-0015
- Other IDs
- NCI-2021-03245, 2021-0015
- Status last verified
- Jul 2026
- First submitted
- 2 May 2021
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04874493
- Acronym / sponsor ID
- 2021-0015
- Conditions
- Oropharyngeal Carcinoma
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 77 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 10 Mar 2021 (actual)
- Primary completion
- 2 Feb 2027 (estimated)
- Study completion
- 2 Feb 2027 (estimated)
- First posted
- 5 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (questionnaire) | – | Other: Electronic Health Record Review, Other: Questionnaire AdministrationPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electronic Health Record ReviewReview of medical records | Other | Observational (questionnaire) |
| Questionnaire AdministrationComplete questionnaire | Other | Observational (questionnaire) |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- M D Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xin S Wang, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oropharyngeal Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.