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 @ 3:04 PM
Ignite Modification Date:
2025-12-24 @ 3:04 PM
NCT ID:
NCT07176559
Eligibility Criteria:
Inclusion Criteria:
1. ≥ 18 years old at the time of informed consent
2. Ability to provide informed consent and HIPAA authorization
3. Subject is at least 2 weeks post-diagnosis of an incurable and advanced stage (IV) lung or gastrointestinal (GI) malignancy and receiving cancer care at IU Simon Cancer Center, other IU Health Oncology Clinics, or Eskenazi Health Oncology Clinics
4. Subject has a reliable phone and is willing to participate in 4 sessions with the chaplain
5. ECOG score ranging from 0 (fully active) to 3 (able to conduct limited self-care in bed or chair more than 50% of waking hours)
6. Has low Spiritual Well-Being score of 35 or less on the FACIT-Sp
7. Subject makes 2 or fewer errors on the Callahan 6-item cognitive screener administered during screening
Exclusion Criteria:
1. Subject makes 3 or more errors on the Callahan 6-item cognitive screener administered during screening, or exhibits significant psychiatric or cognitive impairment (e.g., dementia/delirium, intellectual disability, active psychosis) that in the judgment of the research team would preclude providing informed consent and study participation
2. Currently receiving hospice care Note: subjects who enroll in hospice during the trial will have the option of continuing trial participation
3. Have had a visit with a healthcare chaplain within the past 3 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07176559
Study Brief:
Protocol Section:
NCT07176559