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

NCT05338905 | Active Not Recruiting

• 2 other identifiers: I 2272021NCI-2022-01920
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Change in Health-related quality of life EORTC QLQ-C30

  Baseline to 6 months

• Change in financial burden

  Baseline to 6 months

• Change in caregiver burden

  Baseline to 6 months

• Time to first acute care visits

  At 1 or 6 month

• Locoregional failure

  Time interval from diagnosis to locoregional failure, assessed up to 6 months

Study Arms (2)

Group A (quality of life questionnaire)

EXPERIMENTAL

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; Other: Questionnaire Administration

Group B (standard symptom management)

ACTIVE COMPARATOR

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

Other: Palliative Therapy

Interventions

Palliative Therapy OTHER

Receive standard symptom management

Also known as: Comfort Care, PA-Palliative Therapy, palliation, Palliative, Palliative Care, Palliative Treatment, Symptom Management, Symptoms Management

Group B (standard symptom management)

Quality-of-Life Assessment OTHER

Complete quality of life questionnaire

Also known as: Quality of Life Assessment

Group A (quality of life questionnaire)

Questionnaire Administration OTHER

Complete quality of life questionnaire

Group A (quality of life questionnaire)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Palliative Care; Patient Comfort

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Anurag K Singh

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2022
• First Posted: April 21, 2022
• Study Start: October 11, 2022
• Primary Completion: March 2, 2025
• Study Completion (Estimated): December 17, 2027
• Last Updated: January 23, 2026

Record last verified: 2026-01

Locations

US (1)