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

NCT ID: NCT05338905

Last Updated: 2026-01-23

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-11
• Study Completion Date: 2027-12-17

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-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.

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.

Conditions

Head and Neck Squamous Cell Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Quality-of-Life Assessment

Intervention Type: OTHER

Complete quality of life questionnaire

Questionnaire Administration

Intervention Type: OTHER

Complete quality of life questionnaire

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.

Group Type: ACTIVE_COMPARATOR

Palliative Therapy

Intervention Type: OTHER

Receive standard symptom management

Interventions

Palliative Therapy

Receive standard symptom management

Intervention Type: OTHER

Quality-of-Life Assessment

Complete quality of life questionnaire

Intervention Type: OTHER

Questionnaire Administration

Complete quality of life questionnaire

Intervention Type: OTHER

Other Intervention Names

Comfort Care; PA-Palliative Therapy; palliation; Palliative; Palliative Care; Palliative Treatment; Symptom Management; Symptoms Management; Quality of Life Assessment

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Roswell Park Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anurag K Singh

Role: PRINCIPAL_INVESTIGATOR

Roswell Park Cancer Institute

Locations

Roswell Park Cancer Institute

Buffalo, New York, United States

Countries

United States

Other Identifiers

NCI-2022-01920

Identifier Type: REGISTRY

Identifier Source: secondary_id

I 2272021

Identifier Type: OTHER

Identifier Source: secondary_id

I 2272021

Identifier Type: -

Identifier Source: org_study_id