Pilot Randomized Clinical Trial of Informational Support Versus Spiritual Care (NCT07176559) | Clinical Trial Compass
RecruitingNot Applicable
Pilot Randomized Clinical Trial of Informational Support Versus Spiritual Care
United States36 participantsStarted 2025-09-09
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. ≥ 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Evaluation of feasibility of the Spiritual Care Assessment and Intervention (SCAI) framework vs informational support
Timeframe: Visits 1-4, approximately weekly, within 3 months of enrollment
2
Evaluation of acceptability of the Spiritual Care Assessment and Intervention (SCAI) framework vs informational support
Timeframe: Visits 1-4, approximately weekly, within 3 months of enrollment; survey 1-week post-intervention
3
Test the effects of spiritual care on the outcome of spiritual wellbeing
. Subject makes 2 or fewer errors on the Callahan 6-item cognitive screener administered during screening
Exclusion criteria
. 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