Pilot Randomized Clinical Trial of Informational Support Versus Spiritual Care (PRaCTIS)

Indiana University

Status: Enrolling

Conditions: Lung Cancer; Gastrointestinal Malignancy; Stage IV Lung Cancer

Treatments: Behavioral: Chaplain Intervention Group

Study type: Interventional

Funder types: Other

Identifiers

NCT07176559

IUSCCC-0936

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

Chaplain Intervention Group

Experimental group

Description:

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.

Treatment:

Behavioral: Chaplain Intervention Group

Attention Control Group

No Intervention group

Description:

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.