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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Intensive Symptom Surveillance Guided by Machine Learning-Directed Risk Stratification (INSIGHT)

Conditions
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Head and Neck Squamous Cell Carcinoma

Intervention / Treatment
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* Other: Palliative Therapy
* Other: Quality-of-Life Assessment
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A (quality of life questionnaire)<br>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<br>* Complete quality of life questionnaire<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Complete quality of life questionnaire<br>|
| Active Comparator: Group B (standard symptom management)<br>Patients receive standard symptom management QW during standard of care radiation therapy and for 6 months after completing radiation therapy course. | Other: Palliative Therapy<br>* Receive standard symptom management<br>* Other names: Symptoms Management;|

What is the study measuring?
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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 |