Stage IV Gastrointestinal Cancer, Stage IV Lung Cancer
Conditions
Keywords
lung cancer, gastrointestinal cancer, spiritual care, spiritual wellbeing, spirituality
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALSpiritual Care
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.
BEHAVIORALInformational Support
Participants in the Informational Support comparator arm discuss topics including quality of life, financial resources, and evaluating health information.
Sponsors
Indiana University
Walther Cancer Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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. Eastern Cooperative Oncology Group (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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Test the effects of spiritual care on the outcome of spiritual wellbeing | 1, 6, and 12 weeks post intervention | 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. |
| Evaluation of feasibility of the Spiritual Care Assessment and Intervention (SCAI) framework vs informational support | Visits 1-4, approximately weekly, within 3 months of enrollment | Percentage of participants 1) enrolling; 2) completing 3 or more intervention sessions; 3) completing all study interviews |
| Evaluation of acceptability of the Spiritual Care Assessment and Intervention (SCAI) framework vs informational support | Visits 1-4, approximately weekly, within 3 months of enrollment; survey 1-week post-intervention | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effects of Spiritual Care Assessment and Intervention (SCAI) framework on satisfaction with spiritual care | 1, 6, and 12 weeks post intervention | 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. |
| Effects of Spiritual Care Assessment and Intervention (SCAI) framework on religious coping | 1, 6, and 12 weeks post intervention | 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. |
| Effects of Spiritual Care Assessment and Intervention (SCAI) framework on meaning and purpose | 1, 6, and 12 weeks post intervention | 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. |
| Effects of Spiritual Care Assessment and Intervention (SCAI) framework on positive affect | 1, 6, and 12 weeks post intervention | 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. |
| Effects of Spiritual Care Assessment and Intervention (SCAI) framework on anxiety | 1, 6, and 12 weeks post intervention | 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. |
| Effects of Spiritual Care Assessment and Intervention (SCAI) framework on depression | 1, 6, and 12 weeks post intervention | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORShelley Johns, PsyD
Indiana University
Outcome results
None listed