Actively Recruiting
Pilot Randomized Clinical Trial of Informational Support Versus Spiritual Care for Patients with Stage IV Lung or Gastrointestinal Cancer
Led by Indiana University · Updated on 2026-03-12
36
Participants Needed
4
Research Sites
17 weeks
Total Duration
On this page
Sponsors
I
Indiana University
Lead Sponsor
W
Walther Cancer Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to explore the impact of spiritual care on patients with advanced stage IV lung or gastrointestinal cancer. The study compares chaplain-led spiritual care with informational support to assess effects on spiritual wellbeing, anxiety, depression, satisfaction with spiritual care, and communication quality. It addresses the need for effective spiritual support in this patient population. Participants are randomly assigned to one of two groups: a spiritual care group or an informational support group. The spiritual care group receives four weekly visits with a board-certified or board-eligible chaplain using the Spiritual Care Assessment and Intervention (SCAI) framework. The informational support group receives four weekly visits with a trained social worker discussing topics like quality of life and financial resources. Each visit lasts about 30 minutes and can be conducted by phone or secure video. During the study, participants complete various assessments measuring spiritual wellbeing, anxiety, depression, and satisfaction at 1, 6, and 12 weeks after the intervention. The feasibility and acceptability of the spiritual care framework are evaluated through visits and a survey one week post-intervention. The total participation period spans approximately three months following enrollment, with ongoing monitoring of spiritual and psychological outcomes.
CONDITIONS
Brief Title
Pilot Randomized Clinical Trial of Informational Support Versus Spiritual Care
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years or older at the time of informed consent
- Able to provide informed consent and HIPAA authorization
- Diagnosed at least 2 weeks ago with incurable stage IV lung or gastrointestinal cancer
- Receiving cancer care at specified oncology clinics
- Have access to a reliable phone and willing to participate in 4 sessions with a chaplain
- Eastern Cooperative Oncology Group (ECOG) score between 0 and 3
- Low Spiritual Well-Being score of 35 or less on the FACIT-Sp
- Make 2 or fewer errors on the Callahan 6-item cognitive screener during screening
You will not qualify if you...
- Make 3 or more errors on the Callahan 6-item cognitive screener or have significant psychiatric or cognitive impairment
- Currently receiving hospice care (may continue participation if enrolled during trial)
- Had a healthcare chaplain visit within the past 3 months
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote) for cognitive and eligibility assessments
Duration - Approximately 4 weeks
Participants receive either spiritual care or informational support through weekly sessions over approximately 4 weeks. Spiritual care sessions are led by a chaplain and focus on meaning, relationships, and identity. Informational support sessions are led by a social worker and cover quality of life and health information.
4 weekly visits, each lasting about 30 minutes, conducted by phone or video
Duration - 12 weeks post treatment
Participants are assessed for spiritual wellbeing and other psychosocial outcomes at multiple time points after treatment to evaluate effects of the interventions.
3 follow-up assessments at 1, 6, and 12 weeks post intervention
Trial Site Locations
Total: 4 locations
1
IU Health Joe and Shelly Schwarz Cancer Center
Carmel, Indiana, United States, 46032
Actively Recruiting
2
Indiana University Melvin & Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, United States, 46202
Actively Recruiting
3
Sidney and Lois Eskenazi Hospital
Indianapolis, Indiana, United States, 46202
Actively Recruiting
4
IU Health Arnett Hospital
Lafayette, Indiana, United States, 47905
Actively Recruiting
Research Team
S
Shelley E Varner-Perez, MPH, MDiv, CPH, BCC
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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