Description:
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.
Title
- Brief Title: Feasibility, Acceptability and Preliminary Effects of the Spiritual Care Assessment and Intervention
- Official Title: Feasibility, Acceptability and Preliminary Effects of the Spiritual Care Assessment and Intervention (SCAI) Framework for Adults With Advanced Cancer and Their Caregivers (FCGs): A Clinical Pilot Trial
Clinical Trial IDs
- ORG STUDY ID:
IUSCC-0665
- NCT ID:
NCT03823313
Conditions
- Advanced Cancer
- Metastatic Cancer
Purpose
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.
Detailed Description
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)
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Spiritual Care Assessment and Intervention | Experimental | | |
Eligibility Criteria
Inclusion Criteria:
- Patient is at least 18 years of age.
- Patient is at least 2 weeks post-diagnosis of an incurable and advanced stage (IV)
lung, colorectal, GI neuroendocrine and Hepatobiliary, testicular and esophageal solid
malignancy and receiving cancer care at IU Simon Cancer Center.
- Patient is willing and able to consent, has a reliable phone and willing to
participate in 4 sessions of 30 (+/- 5) minutes per session.
- Patient has a family member or eligible friend considered to be a caregiver and
interested in participating in the study.
- Patient has adequate English fluency for completion of data collection.
- Family Caregiver (FCG) is at least 18 years of age.
- Family Caregiver (FCG) has been invited to participate in the trial with a patient who
meets eligibility criteria above.
- Family Caregiver (FCG) is willing and able to consent and to participate in 4 sessions
of 30 (+/- 5) minutes per session
- Family Caregiver (FCG) has adequate English fluency for completion of data collection.
Exclusion Criteria:
- Patient makes 3 or more errors on a validated 6-item cognitive screener (Appendix A)
or exhibits significant psychiatric or cognitive impairment (e.g., dementia/delirium,
retardation, active psychosis) that in the judgment of the investigators would
preclude providing informed consent and study participation.
- Currently receiving hospice care (patients who enroll in hospice during the trial will
have the option of continuing trial participation).
- Family Caregiver (FCG) exhibits significant psychiatric or cognitive impairment (e.g.,
dementia/delirium, retardation, active psychosis) that in the judgment of the
investigators would preclude providing informed consent and study participation.
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | Accepts Healthy Volunteers |
Primary Outcome Measures
| Measure: | Rate of enrollment |
| Time Frame: | from recruitment to enrollment (i.e. up to 30 days) |
| Safety Issue: | |
| Description: | number of eligible patients that are consented and enrolled in the trial |
Secondary Outcome Measures
| Measure: | Percentage of completed baseline surveys |
| Time Frame: | baseline |
| Safety Issue: | |
| Description: | percentage of completed baseline surveys in enrolled patients |
| Measure: | Percentage of completed follow up surveys |
| Time Frame: | baseline, 1-2 weeks after session 4, 6 weeks, 3 months |
| Safety Issue: | |
| Description: | |
| Measure: | McGrill Quality of Life Questionnaire score |
| Time Frame: | baseline, 1-2 weeks after session 4, 6 weeks, 3 months |
| Safety Issue: | |
| Description: | Measure of patient quality of life through total score at baseline compared to score at 1 week, 6 weeks, and 3 months |
| Measure: | Caregiver Quality of Life Index-Cancer Questionnaire score |
| Time Frame: | baseline, 1 week, 6 weeks, 3 months |
| Safety Issue: | |
| Description: | Measure of caregiver quality of life through total score at baseline compared to score at 1 week, 6 weeks, and 3 months |
| Measure: | Caregiver Quality of Life Index-Cancer Questionnaire score |
| Time Frame: | baseline, 1-2 weeks after session 4, 6 weeks, 3 months |
| Safety Issue: | |
| Description: | Measure of caregiver quality of life through total score at baseline compared to score at 1 week, 6 weeks, and 3 months |
| Measure: | Generalized Anxiety Disorder Scale Scores |
| Time Frame: | baseline, 1-2 weeks after session 4, 6 weeks, 3 months |
| Safety Issue: | |
| Description: | Measure of Anxiety through total score at baseline compared to score at 1 week, 6 weeks, and 3 months |
| Measure: | Patient Health Questionnaire Depression Scale (PHQ-8) |
| Time Frame: | baseline, 1 week, 6 weeks, 3 months |
| Safety Issue: | |
| Description: | Measure of depression through total score at baseline compared to score at 1 week, 6 weeks, and 3 months |
| Measure: | Brief RCOPE score |
| Time Frame: | baseline, 1-2 weeks after session 4, 6 weeks, 3 months |
| Safety Issue: | |
| Description: | Measure of coping through total score at baseline compared to score at 1 week, 6 weeks, and 3 months |
| Measure: | Intervention Satisfaction Questionnaire score |
| Time Frame: | baseline, 1-2 weeks after session 4, 6 weeks, 3 months |
| Safety Issue: | |
| Description: | |
Details
| Phase: | N/A |
| Primary Purpose: | Interventional |
| Overall Status: | Completed |
| Lead Sponsor: | Indiana University |
Trial Keywords
- Spiritual Care
- Religion
- Spirituality
- Caregiver
Last Updated
February 13, 2020
