Feasibility, Acceptability and Preliminary Effects of the Spiritual Care Assessment and Intervention

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

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.

Study Overview

• Status: Completed
• Conditions: Metastatic Cancer; Advanced Cancer
• Intervention / Treatment: Behavioral: SCAI (Spiritual Care Assessment and Intervention)

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)

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University Melvin & Bren Simon Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Spiritual Care Assessment and Intervention	Behavioral: SCAI (Spiritual Care Assessment and Intervention); 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: Indiana University Health
• Investigators: Principal Investigator: Alexia Torke, MD, Indiana University

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2018
• Primary Completion (Actual): August 28, 2019
• Study Completion (Actual): August 28, 2019

Study Registration Dates

• First Submitted: January 29, 2019
• First Submitted That Met QC Criteria: January 29, 2019
• First Posted (Actual): January 30, 2019

Study Record Updates

• Last Update Posted (Actual): February 13, 2020
• Last Update Submitted That Met QC Criteria: February 11, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Caregiver; Religion; Spirituality; Spiritual Care
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis
• Other Study ID Numbers: IUSCC-0665

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No