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 range18 Years

SexALL

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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
✓. 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

What they're measuring

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

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

Test the effects of spiritual care on the outcome of spiritual wellbeing

Timeframe: 1, 6, and 12 weeks post intervention

Trial details

NCT IDNCT07176559

SponsorIndiana University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12

Contact for this trial

Shelley E Varner-Perez, MPH, MDiv, CPH, BCC

317-874-6984 svarnerp@iu.edu

View on ClinicalTrials.gov More Stage IV Lung Cancer trials