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)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Head and Neck Squamous Cell Carcinoma
• Intervention / Treatment: Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Palliative Therapy

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 management on time to first acute care visits at 3 months.

SECONDARY OBJECTIVES:

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 management on (1) changes in health-related quality of life (HRQOL), financial burden, and caregiver burden from baseline, (2) time to first acute care visits at 1 or 6 month, (3) locoregional (LRF) and distant failure (DF), and (4) progression-free (PFS) and overall survival (OS) outcomes.

II. Using study questionnaires to determine the impact of intensive symptom evaluation with supportive care as needed per treating physician's discretion versus standard symptom management when stratified.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP A: Patients complete a quality of life questionnaires over 10-15 minutes twice weekly (BIW) during standard of care radiation therapy and once weekly (QW) for the first month after completing standard of care radiation therapy course, and then once monthly for 6 months.

GROUP B: Patients receive standard symptom management QW during standard of care radiation therapy for 6 months after completing radiation therapy course.

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14263
      • Roswell Park Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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 Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A (quality of life questionnaire); Patients complete a quality of life questionnaires over 10-15 minutes BIW during standard of care radiation therapy and QW for the first month after completing standard of care radiation therapy course, and then once monthly for 6 months.	Other: Quality-of-Life Assessment; Complete quality of life questionnaire; Other Names: Quality of Life Assessment; Other: Questionnaire Administration; Complete quality of life questionnaire
Active Comparator: Group B (standard symptom management); Patients receive standard symptom management QW during standard of care radiation therapy and for 6 months after completing radiation therapy course.	Other: Palliative Therapy; Receive standard symptom management; Other Names: Symptom Management; Comfort Care; Palliative Care; Palliative Treatment; PA-Palliative Therapy; palliation; Palliative; Symptoms Management

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to first acute care visit	to evaluate the impact of intensive symptom evaluation compared to standard symptom management on time to first acute care visits at 3 months with time to first acute care visits.	At 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Health-related quality of life EORTC QLQ-C30	Patient reported outcome assessment measured data Quality of life data will be obtained via European Organisation for Research and Treatment of Cancer Quality of Life Cancer Patients (EORTC QLQ-C30). It It is a 30-item questionnaire assessing other cancer-related symptoms	Baseline to 6 months
Change in financial burden	Change in patient reported outcomes measured using the Comprehensive Score for Financial Toxicity (COST). Financial toxicity is assessed using an 11-item patient-reported measure of financial stress used in cancer patients. The COST yields a total score with higher scores indicating less financial toxicity	Baseline to 6 months
Change in caregiver burden	Will be evaluated with the Caregiver Reaction Assessment (CRA). Summary score range between 5 and 120. A higher score indicates a higher level of burden.	Baseline to 6 months
Time to first acute care visits	Patient reported 9 item questionnaire to evaluate the impact of intensive symptom evaluation compared to standard symptom management on time to first acute care visits at 3 months with time to first acute care visits.	At 1 or 6 month
Locoregional failure	Analyzed with the questionnaire and standard of care tumor assessment, disease progression, and survival status information.	Time interval from diagnosis to locoregional failure, assessed up to 6 months
Distant failure	Analyzed with the questionnaire and standard of care tumor assessment, disease progression, and survival status information.	Time interval from diagnosis to distant failure outside head and neck region, assessed up to 6 months
Progression free survival	Analyzed with the questionnaire and standard of care tumor assessment, disease progression, and survival status information.	Time interval from diagnosis to tumor recurrence or progression of disease, assessed up to 6 months
Overall survival	Analyzed with the questionnaire and standard of care tumor assessment, disease progression, and survival status information.	Time interval from diagnosis to death from any cause, assessed up to 6 months

Collaborators and Investigators

• Sponsor: Roswell Park Cancer Institute
• Investigators: Principal Investigator: Anurag K Singh, Roswell Park Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2022
• Primary Completion (Actual): March 2, 2025
• Study Completion (Estimated): December 17, 2027

Study Registration Dates

• First Submitted: March 29, 2022
• First Submitted That Met QC Criteria: April 14, 2022
• First Posted (Actual): April 21, 2022

Study Record Updates

• Last Update Posted (Actual): January 23, 2026
• Last Update Submitted That Met QC Criteria: January 21, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Head and Neck Neoplasms; Neoplasms, Glandular and Epithelial; Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck; Therapeutics; Patient Care; Health Services; Health Care Facilities Workforce and Services; Palliative Care; Patient Comfort
• Other Study ID Numbers: I 2272021 (Other Identifier: Roswell Park Cancer Institute); NCI-2022-01920 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• 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