NCT05338905Active, not recruiting
Intensive Symptom Surveillance Guided by Machine Learning-Directed Risk Stratification in Patients With Non-Metastatic Head and Neck Cancer, The INSIGHT Trial
Intensive Symptom Surveillance Guided by Machine Learning-Directed Risk Stratification (INSIGHT)
Source: ClinicalTrials.gov · Last updated 23 Jan 2026
Brief summary (registry, in English)
This clinical trial compares intensive symptom evaluation with supportive care to standard symptom management in patients with head and neck cancer that has not spread to other places in the body (non-metastatic). Standard symptom management involves symptom management during and after radiation therapy, using problem-focused history and physical examination followed by appropriate symptomatic management as appropriate per treating physician's discretion. Intensive symptom management with monitoring patient reported outcomes is performed among patients with metastatic cancers receiving systemic therapies and with various cancers receiving radiation therapy. This trial may help researchers determine the impact of intensive symptom surveillance in patients with non-metastatic head and neck cancers.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 72 (actual)
- First submitted
- 29 Mar 2022
- Start date
- 11 Oct 2022
- Primary completion date
- 2 Mar 2025
- Lead sponsor
- Roswell Park Cancer Institute
- Diseases
- Head and neck cancer
- NCT number
- NCT05338905
What you commit to
- Study type: Interventional
- Participants enrolled: 72
- From 11 Oct 2022 to the primary completion date, 2 Mar 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- PATIENTS: Eligible for palliative-intent radiation therapy only
Other illness
- PATIENTS: Diagnosed with metastatic head and neck cancer
- PATIENTS: Any condition which in the Investigator's opinion deems the participant an unsuitable candidate
Other
- PATIENTS: Pregnant female participants
- PATIENTS: Unwilling or unable to follow protocol requirements
Who the study is looking for
- PATIENTS: Age \>= 18 years of age
- PATIENTS: Diagnosed with biopsy-proven, non-metastatic squamous cell carcinoma of head and neck
- PATIENTS: Scheduled to start curative-intent radiation therapy within 4 weeks
- PATIENTS: Able to provide informed consent in English
- PATIENTS: Able to read and write in English
- PATIENTS: Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related assessment
- PATIENTS' INFORMED CAREGIVER (e.g. family members, friends): They are verbally identified by eligible patients as a caregiver
- PATIENTS' INFORMED CAREGIVER (e.g. family members, friends): They are not receiving any payment to provide care for patients
- PATIENTS' INFORMED CAREGIVER (e.g. family members, friends): Able to provide informed consent in English
- PATIENTS' INFORMED CAREGIVER (e.g. family members, friends): Able to read and write in English
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Roswell Park Cancer Institute Coordinator of this site? Confirm its status | Buffalo | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.