Ignite Creation Date:
2025-12-24 @ 3:04 PM
Ignite Modification Date:
2025-12-26 @ 3:08 AM
Study NCT ID:
NCT07176559
Status:
RECRUITING
Last Update Posted:
2025-09-25
First Post:
2025-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Randomized Clinical Trial of Informational Support Versus Spiritual Care
Sponsor:
Indiana University
Organization:
Study Overview
Official Title:
Pilot Randomized Clinical Trial of Informational Support Versus Spiritual Care
Status:
RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRaCTIS
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 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 attention control. 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 group will consist of 4 study visits with a trained social worker once a week for approximately 4 weeks.
Participants will be randomized 1:1 to the chaplain or attention control group.
Participants will be randomized 1:1 to the chaplain or attention control group.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: