Pilot Randomized Clinical Trial of Informational Support Versus Spiritual Care

NCT07176559 | Recruiting DMC

• 1 other identifier: IUSCCC-0936
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Stage IV Lung Cancer; Stage IV Gastrointestinal Cancer

Keywords

lung cancer; gastrointestinal cancer; spiritual care; spiritual wellbeing; spirituality

Outcome Measures

Primary Outcomes (3)

• 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

  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.

  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.

  1, 6, and 12 weeks post intervention

Secondary Outcomes (6)

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

  1, 6, and 12 weeks post intervention

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

  1, 6, and 12 weeks post intervention

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

  1, 6, and 12 weeks post intervention

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

  1, 6, and 12 weeks post intervention

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

  1, 6, and 12 weeks post intervention

Study Arms (2)

Spiritual Care

EXPERIMENTAL

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.

Behavioral: Spiritual Care

Informational Support

PLACEBO COMPARATOR

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.

Behavioral: Informational Support

Interventions

Spiritual Care BEHAVIORAL

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.

Spiritual Care

Informational Support BEHAVIORAL

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

Informational Support

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead
• Walther Cancer Foundation: collaborator

Study Sites (4)

IU Health Joe and Shelly Schwarz Cancer Center

Carmel, Indiana, 46032, United States

RECRUITING

Indiana University Melvin & Bren Simon Comprehensive Cancer Center

Indianapolis, Indiana, 46202, United States

RECRUITING

Sidney and Lois Eskenazi Hospital

Indianapolis, Indiana, 46202, United States

RECRUITING

IU Health Arnett Hospital

Lafayette, Indiana, 47905, United States

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms; Gastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Study Officials

• Shelley Johns, PsyD

  Indiana University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

317-874-6984; svarnerp@iu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine, Research Scientist, Walther Scholar in Psycho-Oncology

Study Record Dates

• First Submitted: August 29, 2025
• First Posted: September 16, 2025
• Study Start: September 9, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: March 12, 2026

Record last verified: 2026-03

Locations

US (4)