NCT07176559

Pilot Randomized Clinical Trial of Informational Support Versus Spiritual Care

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is an individually randomized trial of chaplain-led intervention utilizing the Spiritual Care Assessment and Intervention (SCAI) framework compared to an attention control comparator. The chaplain intervention will consist of 4 spiritual care visits with a board-certified or board-eligible chaplain once a week for approximately 4 weeks. The attention control comparator will consist of 4 informational support visits with a trained social worker once a week for approximately 4 weeks. Participants will be randomized 1:1 to the chaplain-led intervention or the attention control comparator.

Conditions

• Stage IV Lung Cancer
• Stage IV Gastrointestinal Cancer

Interventions

Type	Name	Description
BEHAVIORAL	Spiritual Care	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.
BEHAVIORAL	Informational Support	Participants in the Informational Support comparator arm discuss topics including quality of life, financial resources, and evaluating health information.

Timeline

• Start date: 2025-09-09
• Primary completion: 2026-12-01
• Completion: 2027-04-01
• First posted: 2025-09-16
• Last updated: 2026-03-12

Locations

4 sites across 1 country: United States