Clinical trial NCT05338905: Intensive Symptom Surveillance Guided by Machine Learning-Directed Risk Stratification in Patients With Non-Metastatic Head and Neck Cancer, The INSIGHT Trial
Official title: Intensive Symptom Surveillance Guided by Machine Learning-Directed Risk Stratification (INSIGHT)
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Head and Neck Squamous Cell Carcinoma
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
First posted: 2022-04-21
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to first acute care visit
timeFrame: At 3 months
Secondary outcomes:
measure: Change in Health-related quality of life EORTC QLQ-C30
timeFrame: Baseline to 6 months
measure: Change in financial burden
timeFrame: Baseline to 6 months
measure: Change in caregiver burden
timeFrame: Baseline to 6 months
measure: Time to first acute care visits
timeFrame: At 1 or 6 month
measure: Locoregional failure
timeFrame: Time interval from diagnosis to locoregional failure, assessed up to 6 months
measure: Distant failure
timeFrame: Time interval from diagnosis to distant failure outside head and neck region, assessed up to 6 months
measure: Progression free survival
timeFrame: Time interval from diagnosis to tumor recurrence or progression of disease, assessed up to 6 months
measure: Overall survival
timeFrame: Time interval from diagnosis to death from any cause, assessed up to 6 months
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
affiliation: Roswell Park Cancer Institute
name: Anurag K Singh
role: PRINCIPAL_INVESTIGATOR
References: