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| Name | Class |
|---|---|
| Walther Cancer Foundation | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spiritual Care | Experimental | 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. |
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| Informational Support | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | 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. | 1, 6, and 12 weeks post intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shelley Johns, PsyD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IU Health Joe and Shelly Schwarz Cancer Center | Carmel | Indiana | 46032 | United States | ||
| Indiana University Melvin & Bren Simon Comprehensive Cancer Center |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Informational Support | Behavioral | Participants in the Informational Support comparator arm discuss topics including quality of life, financial resources, and evaluating health information. |
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| 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. | 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. | 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. | 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. | 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. | 1, 6, and 12 weeks post intervention |
| Indianapolis |
| Indiana |
| 46202 |
| United States |
| Sidney and Lois Eskenazi Hospital | Indianapolis | Indiana | 46202 | United States |
| IU Health Arnett Hospital | Lafayette | Indiana | 47905 | United States |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |