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NCT Number: NCT05338905

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Palliative Therapy

Other

Receive standard symptom management

Other names: Comfort Care, PA-Palliative Therapy, palliation, Palliative, Palliative Care, Palliative Treatment, Symptom Management, Symptoms Management

Quality-of-Life Assessment

Other

Complete quality of life questionnaire

Other names: Quality of Life Assessment

Questionnaire Administration

Other

Complete quality of life questionnaire

Primary outcomes

  1. Time to first acute care visit

    Time frame: At 3 months

    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.

Secondary outcomes

  1. Change in Health-related quality of life EORTC QLQ-C30

    Time frame: Baseline to 6 months

    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

  2. Change in financial burden

    Time frame: Baseline to 6 months

    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

  3. Change in caregiver burden

    Time frame: Baseline to 6 months

    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.

  4. Time to first acute care visits

    Time frame: At 1 or 6 month

    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.

  5. Locoregional failure

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

    Analyzed with the questionnaire and standard of care tumor assessment, disease progression, and survival status information.

  6. Distant failure

    Time frame: Time interval from diagnosis to distant failure outside head and neck region, assessed up to 6 months

    Analyzed with the questionnaire and standard of care tumor assessment, disease progression, and survival status information.

  7. Progression free survival

    Time frame: Time interval from diagnosis to tumor recurrence or progression of disease, assessed up to 6 months

    Analyzed with the questionnaire and standard of care tumor assessment, disease progression, and survival status information.

  8. Overall survival

    Time frame: Time interval from diagnosis to death from any cause, assessed up to 6 months

    Analyzed with the questionnaire and standard of care tumor assessment, disease progression, and survival status information.

Sponsors and collaborators

Lead sponsor

Roswell Park Cancer Institute

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2027
First posted
Apr 21, 2022
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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