Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2025-12-24 @ 11:25 PM
NCT ID:
NCT04989556
Eligibility Criteria:
Inclusion Criteria:
* PATIENT: Diagnosis of advanced solid tumor
* PATIENT: Oncologic plan for a phase I trial
* PATIENT: High symptom burden (defined as a score of \>= 4 on at least 1 Edmonton Symptom Assessment Scale \[ESAS\] symptom, AND a global distress score \[GDS\] of \>= 20)
* PATIENT: Reliable telephone and internet access
* PATIENT: Able to communicate verbally in English and provide informed consent
* CAREGIVER: Able to communicate verbally in English and provide informed consent
* CAREGIVER: Reliable telephone and internet access
Exclusion Criteria:
* PATIENT: Low symptom burden defined as scores \< 4 on all ESAS symptoms OR GDS \< 20
* PATIENT: Delirium (i.e. Memorial Delirium Assessment Scale \> 8)
* PATIENT: No reliable telephone or internet access
* CAREGIVER: Refusal to participate in this study
* CAREGIVER: No reliable telephone or internet access
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04989556
Study Brief:
Protocol Section:
NCT04989556