Pilot Randomized Clinical Trial of Informational Support Versus Spiritual Care

Running, not enrolling · Not applicable

Conditions studied: Stage IV Lung Cancer, Stage IV Gastrointestinal Cancer

In brief

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.

Key facts

Study ID

NCT07176559

Run by

Indiana University

People needed

36

Starts

2025-09-09

Expected to finish

2026-09-01

Last updated by the study team

2026-07-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥ 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

You may not qualify if…

• 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

Where it is running

• IU Health Joe and Shelly Schwarz Cancer Center — Carmel, Indiana, United States
• Indiana University Melvin & Bren Simon Comprehensive Cancer Center — Indianapolis, Indiana, United States
• Sidney and Lois Eskenazi Hospital — Indianapolis, Indiana, United States
• IU Health Arnett Hospital — Lafayette, Indiana, United States

Full record on ClinicalTrials.gov

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