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

Roswell Park Comprehensive Cancer Center

Status: Active, not recruiting

Conditions: Head and Neck Squamous Cell Carcinoma

Treatments: Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Palliative Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05338905

NCI-2022-01920 (Registry Identifier)

I 2272021 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 2 patient groups

Group A (quality of life questionnaire)

Experimental group

Description:

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.

Treatment:

Other: Questionnaire Administration

Other: Quality-of-Life Assessment

Group B (standard symptom management)

Active Comparator group

Description:

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

Treatment:

Other: Palliative Therapy