Pilot Randomized Clinical Trial of Informational Support Versus Spiritual Care

Part of paid clinical trials in Carmel, Indiana.

Sponsor
Indiana University
Study ID
NCT07176559
Status
Recruiting
Apply to this trial

Conditions

  • Stage IV Gastrointestinal Cancer
  • Stage IV Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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

Study Details

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.

Key Dates

Start date
Sep 9, 2025
Status verified
Mar 2026
Primary completion
Dec 31, 2026
Completion
Apr 30, 2027

Study Design

Enrollment
36 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Spiritual Care
    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.
  • Placebo Comparator: Informational Support
    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.

Primary Outcome Measure

Evaluation of feasibility of the Spiritual Care Assessment and Intervention (SCAI) framework vs informational support [ Time Frame: Visits 1-4, approximately weekly, within 3 months of enrollment ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
IU Health Joe and Shelly Schwarz Cancer CenterCarmelIndiana46032
Shelley E Varner-Perez, MPH, MDiv, CPH, BCC
[email protected]
317-874-6984
Shelley A Johns, PsyD (PRINCIPAL_INVESTIGATOR)
Indiana University Melvin & Bren Simon Comprehensive Cancer CenterIndianapolisIndiana46202
Shelley E Varner-Perez, MPH, MDiv, CPH, BCC
[email protected]
317-874-6984
Shelley A Johns, PsyD (PRINCIPAL_INVESTIGATOR)
Sidney and Lois Eskenazi HospitalIndianapolisIndiana46202
Shelley E Varner-Perez, MPH, MDiv, CPH, BCC
[email protected]
317-874-6984
Shelley A Johns, PsyD (PRINCIPAL_INVESTIGATOR)
IU Health Arnett HospitalLafayetteIndiana47905
Shelley E Varner-Perez, MPH, MDiv, CPH, BCC
[email protected]
317-874-6984
Shelley A Johns, PsyD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Carmel, IN

By research site
IU Health Joe and Shelly Schwarz Cancer Center· Carmel, INIndiana University Melvin & Bren Simon Comprehensive Cancer Center· Indianapolis, INSidney and Lois Eskenazi Hospital· Indianapolis, INIU Health Arnett Hospital· Lafayette, IN

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