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| Name | Class |
|---|---|
| Indiana University Health | OTHER |
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The purpose of this study is to test a spiritual care intervention for adults with advanced cancer and their caregivers. This intervention will assess 4 areas of spiritual experience: meaning and purpose, relationships, transcendence and peace, self-worth and identity. Participants will be asked to complete questionnaires and participate in 4 sessions with research chaplains.
Several studies have shown that cancer affects multiple dimensions of a patient's life as well as the lives of caregivers and others close to the patient who, when faced with life crises, may use religion and spirituality (R/S) to cope. This study is the first of its kind to incorporate a semi-structured spiritual care and intervention (SCAI) framework into the spiritual care of advanced cancer patients while maintaining proper controls in order to investigate its feasibility, acceptability and potential effects on the emotional and spiritual outcomes of advanced cancer patients and their caregivers. This framework will assess 4 areas of spiritual experience: meaning and purpose, relationships, transcendence and peace, self-worth and identity. Additionally, not only will this study assess acceptability and feasibility of the intervention, it will also track and document coping, satisfaction, anxiety, depression, quality of life outcomes and follow-up with both patient and caregivers following Spiritual Care Assessment and Intervention (SCAI).
Specific Aim 1: To evaluate the feasibility and acceptability of the SCAI intervention for adults with advanced cancer and their caregivers.
Specific Aim 2: To establish our ability to collect outcome data to support a future efficacy trial for patients and their caregivers in the outpatient clinic and home setting.
Specific Aim 3: To test the preliminary impact of the SCAI intervention on patient and caregiver spiritual wellbeing (primary outcome) and quality of life, religious coping, depression, and anxiety (secondary outcomes)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spiritual Care Assessment and Intervention | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SCAI (Spiritual Care Assessment and Intervention) | Behavioral | 4 sessions completed with an IU Health chaplain using a framework of questions called the Spiritual Care Assessment And Intervention tool. The weekly sessions will focus on one of the 4 areas of spiritual experience (meaning and purpose, relationships, transcendence and peace, self-worth and identity) |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of enrollment | number of eligible patients that are consented and enrolled in the trial | from recruitment to enrollment (i.e. up to 30 days) |
| Attendance Rate | proportion of participants who attend all four intervention sessions | 4 weeks |
| Mean Satisfaction Score | satisfaction score among participants on the satisfaction survey | 4 weeks |
| Functional assessment of chronic illness therapy-Spiritual Well-being Scale Scores | Total score at baseline will be compared to score at to the score at 1 week, 6 weeks, and 3 months | baseline, 1-2 weeks after session 4, 6 weeks, 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of completed baseline surveys | percentage of completed baseline surveys in enrolled patients | baseline |
| Percentage of completed follow up surveys | baseline, 1-2 weeks after session 4, 6 weeks, 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexia Torke, MD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Melvin & Bren Simon Cancer Center | Indianapolis | Indiana | 46202 | United States |
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| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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| McGrill Quality of Life Questionnaire score | Measure of patient quality of life through total score at baseline compared to score at 1 week, 6 weeks, and 3 months | baseline, 1-2 weeks after session 4, 6 weeks, 3 months |
| Caregiver Quality of Life Index-Cancer Questionnaire score | Measure of caregiver quality of life through total score at baseline compared to score at 1 week, 6 weeks, and 3 months | baseline, 1 week, 6 weeks, 3 months |
| Caregiver Quality of Life Index-Cancer Questionnaire score | Measure of caregiver quality of life through total score at baseline compared to score at 1 week, 6 weeks, and 3 months | baseline, 1-2 weeks after session 4, 6 weeks, 3 months |
| Generalized Anxiety Disorder Scale Scores | Measure of Anxiety through total score at baseline compared to score at 1 week, 6 weeks, and 3 months | baseline, 1-2 weeks after session 4, 6 weeks, 3 months |
| Patient Health Questionnaire Depression Scale (PHQ-8) | Measure of depression through total score at baseline compared to score at 1 week, 6 weeks, and 3 months | baseline, 1 week, 6 weeks, 3 months |
| Brief RCOPE score | Measure of coping through total score at baseline compared to score at 1 week, 6 weeks, and 3 months | baseline, 1-2 weeks after session 4, 6 weeks, 3 months |
| Intervention Satisfaction Questionnaire score | baseline, 1-2 weeks after session 4, 6 weeks, 3 months |