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 @ 1:42 PM
Ignite Modification Date:
2025-12-24 @ 1:42 PM
NCT ID:
NCT03454295
Eligibility Criteria:
Inclusion Criteria:
Part I Focus group GBM informal caregivers (ICs):
* English-speaking as English proficiency screener and in the best judgment of the consenting professional. This is due to the focus groups being managed in English and the use of certain validated questionnaires only being available in English.
* Age \> 18
* IC to an MSKCC patient with GBM who died a year or more ago
Part II Randomized Intervention of GBM ICs:
* English-speaking as per English proficiency screener and in the best judgment of the consenting professional
* Current ICs to a patient with GBM
* Age ≥ 18
* Score of \> 4 on the Distress Thermometer (DT) and indication that this distress is related in some way to the caregiving role per self-report
Exclusion Criteria:
* In the judgment of the consenting professional, clinician or PI and/or as per medical record, severe psychopathology or cognitive impairment likely to interfere with the participation or completion of the protocol or ability to provide meaningful information
* Another family member of caregiver to the same patients is currently enrolled in the study
* Ultimately, if interested, all caregivers who decline participation or are ineligible for the study for any reason, including because another caregiver of the patient is currently enrolled in the study, will be offered referrals to the MSKCC Counseling Center and to local mental health providers
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03454295
Study Brief:
Protocol Section:
NCT03454295