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

Primary Purpose

Advanced Cancer, Metastatic Cancer

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

SCAI (Spiritual Care Assessment and Intervention)

About this trial

This is an interventional supportive care trial for Advanced Cancer focused on measuring Spiritual Care, Religion, Spirituality, Caregiver

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Indiana University Melvin & Bren Simon Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Spiritual Care Assessment and Intervention

Arm Description

Outcomes

Primary Outcome Measures

Rate of enrollment

number of eligible patients that are consented and enrolled in the trial

Attendance Rate

proportion of participants who attend all four intervention sessions

Mean Satisfaction Score

satisfaction score among participants on the satisfaction survey

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

Secondary Outcome Measures

Percentage of completed baseline surveys

percentage of completed baseline surveys in enrolled patients

Percentage of completed follow up surveys

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

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

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

Generalized Anxiety Disorder Scale Scores

Measure of Anxiety through total score at baseline compared to score at 1 week, 6 weeks, and 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

Brief RCOPE score

Measure of coping through total score at baseline compared to score at 1 week, 6 weeks, and 3 months

Intervention Satisfaction Questionnaire score

Full Information

NCT ID

NCT03823313

First Posted

January 29, 2019

Last Updated

February 11, 2020

Sponsor

Indiana University

Collaborators

Indiana University Health

1. Study Identification

Unique Protocol Identification Number

NCT03823313

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Completed

Study Start Date

December 10, 2018 (Actual)

Primary Completion Date

August 28, 2019 (Actual)

Study Completion Date

August 28, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Indiana University

Collaborators

Indiana University Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Advanced Cancer, Metastatic Cancer

Keywords

Spiritual Care, Religion, Spirituality, Caregiver

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

42 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Spiritual Care Assessment and Intervention

Arm Type

Experimental

Intervention Type

Behavioral

Intervention Name(s)

SCAI (Spiritual Care Assessment and Intervention)

Intervention Description

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)

Primary Outcome Measure Information:

Title

Rate of enrollment

Description

number of eligible patients that are consented and enrolled in the trial

Time Frame

from recruitment to enrollment (i.e. up to 30 days)

Title

Attendance Rate

Description

proportion of participants who attend all four intervention sessions

Time Frame

4 weeks

Title

Mean Satisfaction Score

Description

satisfaction score among participants on the satisfaction survey

Time Frame

4 weeks

Title

Functional assessment of chronic illness therapy-Spiritual Well-being Scale Scores

Description

Total score at baseline will be compared to score at to the score at 1 week, 6 weeks, and 3 months

Time Frame

baseline, 1-2 weeks after session 4, 6 weeks, 3 months

Secondary Outcome Measure Information:

Title

Percentage of completed baseline surveys

Description

percentage of completed baseline surveys in enrolled patients

Time Frame

baseline

Title

Percentage of completed follow up surveys

Time Frame

baseline, 1-2 weeks after session 4, 6 weeks, 3 months

Title

McGrill Quality of Life Questionnaire score

Description

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, 1-2 weeks after session 4, 6 weeks, 3 months

Title

Caregiver Quality of Life Index-Cancer Questionnaire score

Description

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 week, 6 weeks, 3 months

Title

Caregiver Quality of Life Index-Cancer Questionnaire score

Description

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

Title

Generalized Anxiety Disorder Scale Scores

Description

Measure of Anxiety 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

Title

Patient Health Questionnaire Depression Scale (PHQ-8)

Description

Measure of depression 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

Title

Brief RCOPE score

Description

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

Title

Intervention Satisfaction Questionnaire score

Time Frame

baseline, 1-2 weeks after session 4, 6 weeks, 3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alexia Torke, MD

Organizational Affiliation

Indiana University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Indiana University Melvin & Bren Simon Cancer Center

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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