Pilot Randomized Clinical Trial of Informational Support Versus Spiritual Care
Indiana University
36 participants
Sep 9, 2025
INTERVENTIONAL
Conditions
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 wellbeing, anxiety, depression, satisfaction with spiritual care, and quality of communication.
Eligibility
Inclusion Criteria7
- ≥ 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
- Eastern Cooperative Oncology Group (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 Criteria3
- 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
Interventions
Participants in the Spiritual Care intervention discuss topics consistent with the Spiritual Care Assessment and Intervention (SCAI) framework including meaning and purpose, relationships, transcendence and peace, and self-worth and identity.
Participants in the Informational Support comparator arm discuss topics including quality of life, financial resources, and evaluating health information.
Locations(4)
View Full Details on ClinicalTrials.gov
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NCT07176559