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.
This study is an individually randomized trial of chaplain-led intervention utilizing the Spiritual Care Assessment and Intervention (SCAI) framework compared to an attention control comparator. 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 comparator will consist of 4 informational support visits with a trained social worker once a week for approximately 4 weeks. Participants will be randomized 1:1 to the chaplain-led intervention or the attention control comparator.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
36
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.
Participants in the Informational Support comparator arm discuss topics including quality of life, financial resources, and evaluating health information.
IU Health Joe and Shelly Schwarz Cancer Center
Carmel, Indiana, United States
RECRUITINGIndiana University Melvin & Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, United States
RECRUITINGSidney and Lois Eskenazi Hospital
Indianapolis, Indiana, United States
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
Time frame: 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.
Time frame: 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.
Time frame: 1, 6, and 12 weeks post intervention
Effects of Spiritual Care Assessment and Intervention (SCAI) framework on anxiety
Generalized Anxiety Disorder - 7 (GAD-7): Anxiety will be measured by the Generalized Anxiety Disorder-7 item survey. Each item is rated when considering the past two weeks on a scale from 0 (not at all) to 3 (nearly every day). Scores are the sum of individual items with total scores ranging from 0 to 21. Scores of 5-9, 10-14, and 15 and above indicate mild, moderate, and severe anxiety, respectively. This is a secondary outcome for patients.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
IU Health Arnett Hospital
Lafayette, Indiana, United States
RECRUITINGTime frame: 1, 6, and 12 weeks post intervention
Effects of Spiritual Care Assessment and Intervention (SCAI) framework on depression
Patient Health Questionnaire-8 (PHQ-8): Depressive symptoms will be measured using the Patient Health Questionnaire-8 item survey. Each item is rated when considering the past two weeks on a scale from 0 (not at all) to 3 (nearly every day). Scores are the sum of individual items with total scores ranging from 0 to 24. Scores of 5-9, 10-14, and 15 and above indicate mild, moderate, and severe depression, respectively. This is a secondary outcome for patients.
Time frame: 1, 6, and 12 weeks post intervention
Effects of Spiritual Care Assessment and Intervention (SCAI) framework on satisfaction with spiritual care
Client Satisfaction Questionnaire (CSQ): Satisfaction will be assessed using the 8-item Client Satisfaction Questionnaire. Each item is rated on a scale from 1 to 4. Items # 1, 3, 6, and 7 are reverse-scored and then the 8 items are summed with higher total scores indicating greater satisfaction. This is a secondary outcome for patients.
Time frame: 1, 6, and 12 weeks post intervention
Effects of Spiritual Care Assessment and Intervention (SCAI) framework on meaning and purpose
Patient-Reported Outcomes Measurement Information System (PROMIS) Meaning \& Purpose Short Form: Meaning and purpose will be assessed using this 7-item PROMIS measure. Each item is rated when considering the past week on a scale from 1 (not at all) to 5 (very much). The 7 items are summed with higher total scores indicating greater meaning and purpose. This is a secondary outcome for patients.
Time frame: 1, 6, and 12 weeks post intervention
Effects of Spiritual Care Assessment and Intervention (SCAI) framework on religious coping
Brief Religious Coping Scale (RCOPE): Religious coping will be measured using the 14-item Brief Religious Coping Scale, which includes two subscales of 7 items each: positive religious coping and negative religious coping. Each item is rated on a scale from 0 (not at all) to 3 (a great deal). Subscale scores are calculated separately as sum scores. Scores range from 0 to 21 for each subscale, with higher scores indicating higher usage. The subscale scores are analyzed independently, as they are often uncorrelated. This is a secondary outcome for patients.
Time frame: 1, 6, and 12 weeks post intervention
Effects of Spiritual Care Assessment and Intervention (SCAI) framework on positive affect
Patient-Reported Outcomes Measurement Information System (PROMIS) Positive Affect Short Form: Positive affect will be assessed using this 15-item PROMIS measure. Each item is rated when considering the past week on a scale from 1 (not at al) to 5 (very much). The 15 items are summed with higher total scores indicating greater positive affect. This is a secondary outcome for patients.
Time frame: 1, 6, and 12 weeks post intervention