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

Head and Neck Squamous Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05338905
• Other study ID #: I 2272021
• Secondary ID: NCI-2022-01920I
• Status: Recruiting
• Phase: N/A
• Start date: September 26, 2022
• Est. completion date: October 30, 2025

Study information

• Verified date: August 2023
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: October 30, 2025
• Est. primary completion date: October 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Squamous Cell Carcinoma
• Squamous Cell Carcinoma of Head and Neck

Intervention

Other:
• Palliative Therapy
Receive standard symptom management
• Quality-of-Life Assessment
Complete quality of life questionnaire
• Questionnaire Administration
Complete quality of life questionnaire

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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