Indiana University Melvin & Bren Simon Cancer Center
Indianapolis, Indiana, 46202, United States
NCT Number: NCT03823313
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Indianapolis, Indiana, 46202, United States
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)
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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)
Time frame: from recruitment to enrollment (i.e. up to 30 days)
number of eligible patients that are consented and enrolled in the trial
Time frame: 4 weeks
proportion of participants who attend all four intervention sessions
Time frame: 4 weeks
satisfaction score among participants on the satisfaction survey
Time frame: baseline, 1-2 weeks after session 4, 6 weeks, 3 months
Total score at baseline will be compared to score at to the score at 1 week, 6 weeks, and 3 months
Time frame: baseline
percentage of completed baseline surveys in enrolled patients
Time frame: baseline, 1-2 weeks after session 4, 6 weeks, 3 months
Time frame: baseline, 1-2 weeks after session 4, 6 weeks, 3 months
Measure of patient quality of life through total score at baseline compared to score at 1 week, 6 weeks, and 3 months
Time frame: baseline, 1 week, 6 weeks, 3 months
Measure of caregiver quality of life through total score at baseline compared to score at 1 week, 6 weeks, and 3 months
Time frame: baseline, 1-2 weeks after session 4, 6 weeks, 3 months
Measure of caregiver quality of life through total score at baseline compared to score at 1 week, 6 weeks, and 3 months
Time frame: baseline, 1-2 weeks after session 4, 6 weeks, 3 months
Measure of Anxiety through total score at baseline compared to score at 1 week, 6 weeks, and 3 months
Time frame: baseline, 1 week, 6 weeks, 3 months
Measure of depression through total score at baseline compared to score at 1 week, 6 weeks, and 3 months
Time frame: baseline, 1-2 weeks after session 4, 6 weeks, 3 months
Measure of coping through total score at baseline compared to score at 1 week, 6 weeks, and 3 months
Time frame: baseline, 1-2 weeks after session 4, 6 weeks, 3 months
Indiana University
Other
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05375994
Advanced Cancer, Bronchial Neoplasms
San Francisco, California, United States
View Trial DetailsNCT04991480
Advanced Cancer, Breast Cancer
New Haven, Connecticut, United States
View Trial DetailsNCT03510104
Advanced Cancer, Metastatic Cancer
Atlanta, Georgia, United States
View Trial DetailsNCT04648254
Advanced Cancer, Metastatic Cancer
Los Angeles, California, United States
View Trial Details