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

NCT03823313 | Completed DMC

• 1 other identifier: IUSCC-0665
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Cancer; Metastatic Cancer

Keywords

Spiritual Care; Religion; Spirituality; Caregiver

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (9)

• Percentage of completed baseline surveys

  baseline

• Percentage of completed follow up surveys

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

• McGrill Quality of Life Questionnaire score

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

• Caregiver Quality of Life Index-Cancer Questionnaire score

  baseline, 1 week, 6 weeks, 3 months

• Caregiver Quality of Life Index-Cancer Questionnaire score

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

Study Arms (1)

Spiritual Care Assessment and Intervention

EXPERIMENTAL

Behavioral: SCAI (Spiritual Care Assessment and Intervention)

Interventions

SCAI (Spiritual Care Assessment and Intervention) BEHAVIORAL

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)

Spiritual Care Assessment and Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indiana University: lead
• Indiana University Health: collaborator

Study Sites (1)

Indiana University Melvin & Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

Methods

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Alexia Torke, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine and Associate Division Chief of General Internal Medicine and Geriatrics

Study Record Dates

• First Submitted: January 29, 2019
• First Posted: January 30, 2019
• Study Start: December 10, 2018
• Primary Completion: August 28, 2019
• Study Completion: August 28, 2019
• Last Updated: February 13, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)