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Pilot Randomized Clinical Trial of Informational Support Versus Spiritual Care

NCT ID: NCT07176559Sponsor: Indiana UniversityLast updated: 2026-03-12

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 an attention control comparator. 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 comparator will consist of 4 informational support visits with a trained social worker once a week for approximately 4 weeks. Participants will be randomized 1:1 to the chaplain-led intervention or the attention control comparator.

Arms & interventions

  • BehavioralSpiritual Care

    Participants in the Spiritual Care intervention discuss topics consistent with the Spiritual Care Assessment and Intervention (SCAI) framework including meaning and purpose, relationships, transcendence and peace, and self-worth and identity.

  • BehavioralInformational Support

    Participants in the Informational Support comparator arm discuss topics including quality of life, financial resources, and evaluating health information.

Outcome measures

Primary

  • Evaluation of feasibility of the Spiritual Care Assessment and Intervention (SCAI) framework vs informational support

    Percentage of participants 1) enrolling; 2) completing 3 or more intervention sessions; 3) completing all study interviews

    Time frame: 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

    Acceptability Intervention Measure (AIM) This 4-item scale was developed as part of the Consolidated Framework for Implementation Research (CFIR) to evaluate intervention acceptability. Each item is rated on a 5-point scale, ranging from 1 (completely disagree) to 5 (completely agree). Responses are averaged to create a scale score. Higher scores indicate greater acceptability. This is a primary outcome for patients.

    Time frame: 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

    Measured by the Functional Assessment of Chronic Illness Therapy - Spirituality (FACIT-Sp): Spiritual wellbeing will be assessed using the Functional Assessment of Chronic Illness Therapy-Spirituality (FACIT-Sp) 12-item measure. Each item is rated when considering the past week on a scale from 0 (not at all) to 4 (very much). Scores are the sum of individual items with total scores ranging from 0 to 48. Higher scores indicate higher spiritual well-being. This is a primary outcome for patients.

    Time frame: 1, 6, and 12 weeks post intervention

Secondary

  • Effects of Spiritual Care Assessment and Intervention (SCAI) framework on anxiety

    Time frame: 1, 6, and 12 weeks post intervention

  • Effects of Spiritual Care Assessment and Intervention (SCAI) framework on depression

    Time frame: 1, 6, and 12 weeks post intervention

  • Effects of Spiritual Care Assessment and Intervention (SCAI) framework on satisfaction with spiritual care

    Time frame: 1, 6, and 12 weeks post intervention

  • Effects of Spiritual Care Assessment and Intervention (SCAI) framework on meaning and purpose

    Time frame: 1, 6, and 12 weeks post intervention

  • Effects of Spiritual Care Assessment and Intervention (SCAI) framework on religious coping

    Time frame: 1, 6, and 12 weeks post intervention

  • Effects of Spiritual Care Assessment and Intervention (SCAI) framework on positive affect

    Time frame: 1, 6, and 12 weeks post intervention

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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

Study locations (4)

IU Health Joe and Shelly Schwarz Cancer Center

Carmel, Indiana, 46032

Recruiting
Shelley E Varner-Perez, MPH, MDiv, CPH, BCC · Contact
317-874-6984svarnerp@iu.edu
Shelley A Johns, PsyD · Principal Investigator

Indiana University Melvin & Bren Simon Comprehensive Cancer Center

Indianapolis, Indiana, 46202

Recruiting
Shelley E Varner-Perez, MPH, MDiv, CPH, BCC · Contact
317-874-6984svarnerp@iu.edu
Shelley A Johns, PsyD · Principal Investigator

Sidney and Lois Eskenazi Hospital

Indianapolis, Indiana, 46202

Recruiting
Shelley E Varner-Perez, MPH, MDiv, CPH, BCC · Contact
317-874-6984svarnerp@iu.edu
Shelley A Johns, PsyD · Principal Investigator

IU Health Arnett Hospital

Lafayette, Indiana, 47905

Recruiting
Shelley E Varner-Perez, MPH, MDiv, CPH, BCC · Contact
317-874-6984svarnerp@iu.edu
Shelley A Johns, PsyD · Principal Investigator
Pilot Randomized Clinical Trial of Informational Support Versus Spiritual Care | Cancerify