Chaplain-led spiritual care versus informational support for people with advanced lung or gastrointestinal cancer
Pilot Randomized Clinical Trial of Informational Support Versus Spiritual Care
This project will test whether four weekly chaplain visits improve spiritual well-being, anxiety, depression, and satisfaction with spiritual care compared with four weekly informational support visits for adults with stage IV lung or gastrointestinal cancer who have low spiritual well-being.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Indiana University Academic / other |
| Locations | 4 sites (Carmel, Indiana and 3 other locations) |
| Trial ID | NCT07176559 on ClinicalTrials.gov |
What this trial studies
This is a randomized, individual trial comparing a chaplain-led Spiritual Care Assessment and Intervention (SCAI) delivered in four weekly visits to an attention-control of four weekly informational support visits by a trained social worker. Adults with stage IV lung or gastrointestinal cancer, low spiritual well-being (FACIT‑Sp ≤35), ECOG 0–3, and adequate cognition will be randomized 1:1 and complete outcomes on spiritual wellbeing, anxiety, depression, satisfaction with spiritual care, and quality of communication. The chaplain visits are delivered by board-certified or board-eligible chaplains once weekly for about four weeks, and the control visits mirror timing and attention. The trial is conducted at Indiana University–affiliated oncology sites and uses brief cognitive and eligibility screening prior to enrollment.
Who should consider this trial
Good fit: Adults (≥18) with stage IV lung or gastrointestinal cancer receiving care at the listed Indiana sites who have low spiritual well-being (FACIT‑Sp ≤35), ECOG 0–3, can consent, pass the brief cognitive screener, and are willing to participate in four weekly sessions are ideal candidates.
Not a fit: Patients with higher baseline spiritual well-being, significant cognitive impairment, uncontrolled psychiatric illness, or those unwilling or unable to complete four weekly sessions are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, chaplain-led spiritual care could improve spiritual well-being, reduce anxiety and depression, and increase satisfaction with spiritual support and communication for people with advanced lung or GI cancer.
How similar studies have performed: Previous supportive and spiritual care interventions have shown mixed but sometimes promising effects on spiritual well-being and mood, while randomized evidence for structured chaplain-led SCAI interventions in advanced lung or GI cancer remains limited.
Eligibility criteria
Show full inclusion / exclusion 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. 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) 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
Where this trial is running
Carmel, Indiana and 3 other locations
- IU Health Joe and Shelly Schwarz Cancer Center — Carmel, Indiana, United States (Recruiting)
- Indiana University Melvin & Bren Simon Comprehensive Cancer Center — Indianapolis, Indiana, United States (Recruiting)
- Sidney and Lois Eskenazi Hospital — Indianapolis, Indiana, United States (Recruiting)
- IU Health Arnett Hospital — Lafayette, Indiana, United States (Recruiting)
Study contacts
- Principal investigator: Shelley Johns, PsyD — Indiana University
- Study coordinator: Shelley E Varner-Perez, MPH, MDiv, CPH, BCC
- Email: svarnerp@iu.edu
- Phone: 317-874-6984
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.