Intensive Symptom Surveillance Guided by Machine Learning-Directed Risk Stratification in Patients With Non-Metastatic Head and Neck Cancer, The INSIGHT Trial

Last updated: January 21, 2026
Sponsor: Roswell Park Cancer Institute
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Head And Neck Cancer

Squamous Cell Carcinoma

Treatment

Palliative Therapy

Quality-of-Life Assessment

Questionnaire Administration

Clinical Study ID

NCT05338905
I 2272021
NCI-2022-01920
I 2272021
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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-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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • PATIENTS: Age >= 18 years of age

  • PATIENTS: Diagnosed with biopsy-proven, non-metastatic squamous cell carcinoma ofhead 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 andsign an Independent Ethics Committee/Institutional Review Board approved writteninformed consent form prior to receiving any study related assessment

  • PATIENTS' INFORMED CAREGIVER (e.g. family members, friends): They are verballyidentified by eligible patients as a caregiver

  • PATIENTS' INFORMED CAREGIVER (e.g. family members, friends): They are not receivingany payment to provide care for patients

  • PATIENTS' INFORMED CAREGIVER (e.g. family members, friends): Able to provideinformed consent in English

  • PATIENTS' INFORMED CAREGIVER (e.g. family members, friends): Able to read and writein English

Exclusion

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 anunsuitable candidate

Study Design

Total Participants: 72
Treatment Group(s): 3
Primary Treatment: Palliative Therapy
Phase:
Study Start date:
October 11, 2022
Estimated Completion Date:
December 17, 2027

Study 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.

Connect with a study center

  • Roswell Park Cancer Institute

    Buffalo, New York 14263
    United States

    Site Not Available

  • Roswell Park Cancer Institute

    Buffalo 5110629, New York 5128638 14263
    United States

    Site Not Available

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