Status:
ACTIVE_NOT_RECRUITING
Intensive Symptom Surveillance Guided by Machine Learning-Directed Risk Stratification in Patients With Non-Metastatic Head and Neck Cancer, The INSIGHT Trial
Lead Sponsor:
Roswell Park Cancer Institute
Conditions:
Head and Neck Squamous Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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...
Detailed Description
PRIMARY OBJECTIVE: I. Using study questionnaires to determine the impact of intensive symptom evaluation with supportive care as needed per treating physician's discretion versus standard symptom man...
Eligibility Criteria
Inclusion
- 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
Exclusion
- PATIENTS: Diagnosed with metastatic head and neck cancer
- PATIENTS: Eligible for palliative-intent radiation therapy only
- PATIENTS: Pregnant female participants
- PATIENTS: Unwilling or unable to follow protocol requirements
- PATIENTS: Any condition which in the Investigator's opinion deems the participant an unsuitable candidate
Key Trial Info
Start Date :
October 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 25 2026
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT05338905
Start Date
October 11 2022
End Date
August 25 2026
Last Update
October 2 2025
Active Locations (1)
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1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263