Clinical trial · Interventional
Pilot Randomized Clinical Trial of Informational Support Versus Spiritual Care
NCT07176559CI-TRIAL-00116603PRaCTISactive not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stage IV Gastrointestinal Cancer | Malignant Digestive System Neoplasm | CURATED_BROADER | 0.78 |
| Stage IV Lung Cancer | Malignant Lung Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Informational Support | Behavioral | — | UNRESOLVED |
| Spiritual Care | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Spiritual Care
- description
- Eligible and consented patients randomly assigned to the spiritual care intervention will receive a total of 4 visits with a board-certified or board-eligible chaplain. The intervention will utilize the Spiritual Care Assessment and Intervention (SCAI) framework. These visits will occur weekly for approximately 4 weeks either by telephone or through a HIPAA compliant video platform. The visits will last an average of 30 minutes each.
- interventionNames
- Behavioral: Spiritual Care
- type
- PLACEBO_COMPARATOR
- label
- Informational Support
- description
- Eligible and consented patients randomly assigned to the Informational Support comparator will receive 4 visits with a trained social worker. The comparator intervention will include discussion of topics including quality of life, financial resources, and evaluating health information. These visits will be conducted weekly for approximately 4 weeks. Each visit will take place for approximately 30 minutes.
- interventionNames
- Behavioral: Informational Support
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.