Pilot Randomized Clinical Trial of Informational Support Versus Spiritual Care

NCT ID: NCT07176559

Last Updated: 2025-09-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-09
• Study Completion Date: 2028-01-31

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.

Detailed Description

This study is an individually randomized trial of chaplain-led intervention utilizing the Spiritual Care Assessment and Intervention (SCAI) framework compared to attention control. 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 group will consist of 4 study visits with a trained social worker once a week for approximately 4 weeks.

Participants will be randomized 1:1 to the chaplain or attention control group.

Conditions

Stage IV Lung Cancer; Lung Cancer; Gastrointestinal Malignancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Chaplain Intervention Group

Eligible and consented participants that are randomized to the Chaplain Intervention Group will receive a total of 4 visits with a board-certified or board-eligible chaplain. These visits will occur weekly for approximately 4 weeks either in person, by telephone, or through a HIPAA compliant video platform. The visits will last an average of 30 minutes each.

Group Type: EXPERIMENTAL

Chaplain Intervention Group

Intervention Type: BEHAVIORAL

Eligible and consented participants that are randomized to the Chaplain Intervention Group will receive a total of 4 visits with a board-certified or board-eligible chaplain. These visits will occur weekly for approximately 4 weeks either in person, by telephone, or through a HIPAA compliant video platform. The visits will last an average of 30 minutes each.

Attention Control Group

Eligible and consented patients randomized to the Attention Control group will receive 4 visits with a trained social worker. The visits will be conducted weekly for approximately 4 weeks. Each visit will take place for approximately 30 minutes.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Chaplain Intervention Group

Eligible and consented participants that are randomized to the Chaplain Intervention Group will receive a total of 4 visits with a board-certified or board-eligible chaplain. These visits will occur weekly for approximately 4 weeks either in person, by telephone, or through a HIPAA compliant video platform. The visits will last an average of 30 minutes each.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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. 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Walther Cancer Foundation

UNKNOWN

Sponsor Role: collaborator

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Alexia M. Torke

Professor of Medicine and Section Chief, Palliative Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alexia M Torke, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

Indiana University Melvin & Bren Simon Comprehensive Cancer Center

Indianapolis, Indiana, United States

Site Status: RECRUITING

Sidney and Lois Eskenazi Hospital

Indianapolis, Indiana, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

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

Role: CONTACT

svarnerp@iu.edu

317-874-6984

Facility Contacts

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

Role: primary

svarnerp@iu.edu

317-874-6984

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

Role: primary

svarnerp@iu.edu

317-874-6984

Other Identifiers

IUSCCC-0936

Identifier Type: -

Identifier Source: org_study_id