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Head and Neck Squamous Cell CarcinomaNCT05338905

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

A study testing Palliative Therapy, Quality-of-Life Assessment and Questionnaire Administration in people with Head and Neck Squamous Cell Carcinoma, run by Roswell Park Cancer Institute at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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). Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Head and Neck Squamous Cell Carcinoma
What is being tested?
Palliative Therapy, Quality-of-Life Assessment and Questionnaire Administration
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
1 siteUnited States
Study dates
11 Oct 2022to 17 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

United States1 site

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

Other trials in United States

About this study

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

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. 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:

  1. 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.

Being tested
Palliative Therapy, Quality-of-Life Assessment, Questionnaire Administration
Medical subject headings
Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Palliative TherapyOther

    Also called Comfort Care, PA-Palliative Therapy, palliation, Palliative

    Receive standard symptom management

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Complete quality of life questionnaire

  • Questionnaire AdministrationOther

    Complete quality of life questionnaire

Study groups in NCT05338905
Study groupRoleWhat they receive
Group A (quality of life questionnaire)ExperimentalPatients 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.
Receives: Other: Quality-of-Life Assessment; Other: Questionnaire Administration
Group B (standard symptom management)Active comparatorPatients receive standard symptom management QW during standard of care radiation therapy and for 6 months after completing radiation therapy course.
Receives: Other: Palliative Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: At 3 months

Secondary outcomes (8)

  1. 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

    Measured: Baseline to 6 months

  2. 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

    Measured: Baseline to 6 months

  3. 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.

    Measured: Baseline to 6 months

  4. 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.

    Measured: At 1 or 6 month

  5. Locoregional failure

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

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

  6. Distant failure

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

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

  7. Progression free survival

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

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

  8. Overall survival

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Apr 2022
  2. Study start11 Oct 2022
  3. Primary completion2 Mar 2025
  4. Study completion17 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05338905
Sponsor's protocol ID
I 2272021
Other IDs
NCI-2022-01920, I 2272021
Status last verified
Jan 2026
First submitted
29 Mar 2022
Last updated
23 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Palliative Therapy, Quality-of-Life Assessment and Questionnaire Administration in people with Head and Neck Squamous Cell Carcinoma, run by Roswell Park Cancer Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to first acute care visit (time frame: At 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05338905.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.

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