Status:
RECRUITING
Pilot Randomized Clinical Trial of Informational Support Versus Spiritual Care
Lead Sponsor:
Indiana University
Collaborating Sponsors:
The Walther Cancer Foundation
Conditions:
Stage IV Lung Cancer
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to address the need for effective spiritual care support for patients with lung and gastrointestinal cancer. This study will examine how spiritual care affects spiritual w...
Detailed Description
This study is an individually randomized trial of chaplain-led intervention utilizing the Spiritual Care Assessment and Intervention (SCAI) framework compared to attention control. The chaplain interv...
Eligibility Criteria
Inclusion
- ≥ 18 years old at the time of informed consent
- Ability to provide informed consent and HIPAA authorization
- 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
- Subject has a reliable phone and is willing to participate in 4 sessions with the chaplain
- 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)
- Has low Spiritual Well-Being score of 35 or less on the FACIT-Sp
- Subject makes 2 or fewer errors on the Callahan 6-item cognitive screener administered during screening
Exclusion
- 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
- Currently receiving hospice care Note: subjects who enroll in hospice during the trial will have the option of continuing trial participation
- Have had a visit with a healthcare chaplain within the past 3 months
Key Trial Info
Start Date :
September 9 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2028
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT07176559
Start Date
September 9 2025
End Date
January 1 2028
Last Update
September 25 2025
Active Locations (2)
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1
Indiana University Melvin & Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, United States, 46202
2
Sidney and Lois Eskenazi Hospital
Indianapolis, Indiana, United States, 46202