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

Metastatic Cancer Clinical Trial

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 Details — Status: Completed

Administrative data

• NCT number: NCT03823313
• Other study ID #: IUSCC-0665
• Status: Completed
• Phase: N/A
• Start date: December 10, 2018
• Est. completion date: August 28, 2019

Study information

• Verified date: February 2020
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: August 28, 2019
• Est. primary completion date: August 28, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Cancer
• Metastatic Cancer
• Neoplasm Metastasis

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)

Locations

Country	Name	City	State
United States	Indiana University Melvin & Bren Simon Cancer Center	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	Indiana University Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	Attendance Rate	proportion of participants who attend all four intervention sessions	4 weeks
Primary	Mean Satisfaction Score	satisfaction score among participants on the satisfaction survey	4 weeks
Primary	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	Percentage of completed baseline surveys	percentage of completed baseline surveys in enrolled patients	baseline
Secondary	Percentage of completed follow up surveys		baseline, 1-2 weeks after session 4, 6 weeks, 3 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Intervention Satisfaction Questionnaire score		baseline, 1-2 weeks after session 4, 6 weeks, 3 months