RECRUITING

Pilot Randomized Clinical Trial of Informational Support Versus Spiritual Care

Conditions

Stage IV Lung Cancer Lung Cancer Gastrointestinal Malignancy gastrointestinal cancer spiritual care spiritual wellbeing spirituality

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Pilot Randomized Clinical Trial of Informational Support Versus Spiritual Care

Quick Facts

Study Start:2025-09

Study Completion:2028-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07176559

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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

Inclusion Criteria

Exclusion 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

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

Contacts and Locations

Study Contact

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

CONTACT

317-874-6984

svarnerp@iu.edu

Principal Investigator

Alexia M Torke, MD, MS

PRINCIPAL_INVESTIGATOR

Indiana University

Study Locations (Sites)

Indiana University Melvin & Bren Simon Comprehensive Cancer Center

Indianapolis, Indiana, 46202

United States

Sidney and Lois Eskenazi Hospital

Indianapolis, Indiana, 46202

United States

Collaborators and Investigators

Sponsor: Indiana University

Alexia M Torke, MD, MS, PRINCIPAL_INVESTIGATOR, Indiana University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-09

Study Completion Date2028-01

Study Record Updates

Study Start Date2025-09

Study Completion Date2028-01

Terms related to this study

Keywords Provided by Researchers

lung cancer
gastrointestinal cancer
spiritual care
spiritual wellbeing
spirituality

Additional Relevant MeSH Terms

Stage IV Lung Cancer
Lung Cancer
Gastrointestinal Malignancy