This trial studies how well a religious and spiritual tool called spiritual care assessment and intervention (SCAI) framework works in supporting the emotional and spiritual well being of patients with cancer that has spread to other places in the body and their caregivers. SCAI framework is an approach to spiritual care delivered by skilled chaplains, that covers the spiritual dimensions of meaning and purpose, relationships, peace, and self-worth and identity. Participating in the SCAI framework may enable doctors to examine a participant’s spiritual strengths and distress and find out the most effective spiritual care intervention for that participant.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03823313.
PRIMARY OBJECTIVES:
I. To evaluate the feasibility and acceptability of the SCAI intervention for adults with advanced cancer and their caregivers.
II. 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.
III. To test the preliminary impact of the SCAI intervention on patient and caregiver spiritual wellbeing (primary outcome) and quality of life, religious coping, hope, depression, and anxiety (secondary outcomes).
OUTLINE:
Participants attend 4 weekly SCAI sessions with a chaplain over 30 minutes each. Each session focuses on one dimension (meaning and purpose, relationships, peace, and self-worth and identity) only.
After completion of study, participants are followed up within 7-14 days, 6-8 weeks, and 12-14 weeks.
Trial PhasePhase I
Trial Typesupportive care
Lead OrganizationIndiana University/Melvin and Bren Simon Cancer Center
Principal InvestigatorSaneta M. Maiko