CCSH (Compassion-Centered Spiritual Health) for Teams

Not Applicable

Not yet recruiting

• Conditions: Health Behavior

• Registration Number: NCT06722027
• Lead Sponsor: Emory University

Brief Summary

Emory Spiritual Health has developed a Compassion-Centered Spiritual Health group-based intervention, called CCSH Interventions for Teams, and are enrolling staff and providers into the groups in this randomized study design. The groups will meet once every other week for 60 minutes for 8 weeks (4 sessions total).

The investigators will evaluate the feasibility and acceptability of this novel team-based intervention that includes mindfulness and compassion-based approaches with mixed-role oncology teams. Employees (n = 80; nurses, advanced practice providers (APPs), physicians, staff) working at an NCI- designated Comprehensive Cancer Center will be randomized by team (8-12 employees/group) to Compassion Centered Spiritual Health Team Intervention (CCSH-TI) or TAU (Treatment as Usual) group. The research objective is to evaluate the feasibility and acceptability of CCSH-TI, and to develop and validate a novel, low-burden ambulatory assessment "toolkit" to improve the measurement of psychological safety and burnout.

Detailed Description

Current interventions to reduce provider burnout are only minimally effective. To overcome the barriers to achieving success in burnout prevention interventions, the investigators propose Compassion Centered Spiritual Health Team Intervention (CCSH-TI), a 4-session intervention delivered by healthcare chaplains to mixed-role interprofessional teams that includes mindfulness and compassion-based approaches to bolster resilience, compassion for self and others, and psychological safety. The research team will conduct a mixed-method feasibility and acceptability study of CCSH-TI with mixed-role oncology teams. Employees (n = 80; nurses, advanced practice providers (APPs), physicians, staff) working at an NCI-designated Comprehensive Cancer Center will be randomized by team (8-12 employees/group) to CCSH-TI or to TAU (Treatment as Usual) group, who has access to all well-being resources and activities available to them as employees. Self-report surveys and focus group discussions will be used to evaluate the feasibility and acceptability of CCSH-TI. The investigators will also collect self-report surveys, ecological momentary assessments (EMA), and the electronically activated recorder (EAR) data at 3 timepoints (before CCSH-TI (T1), immediately after completion of CCSH-TI (T2), and 12-weeks after completion (LT), and characterize data completion to evaluate the feasibility of data collection methods for a future randomized control trial. Informed consent will be obtained from study participants in-person. The duration of the study will be 22-23 weeks (from consent to completion of data collection).

Study Timeline

• Study First Submitted: 2024-12-03
• Study First Submitted QC: 2024-12-03
• Study First Posted: 2024-12-09
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-02
• Last Update Posted: 2025-06-05
• Study Start: 2025-07
• Primary Completion: 2026-05-15
• Study Completion: 2026-11-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Full-time employees working in oncology teams at Winship Cancer Institute;
• Employees working in intensive care at Emory University St. Joseph hospital.

Exclusion Criteria

• Less than 18 years old

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Proportion of eligible employees who enroll and are willing to be randomized	BaselineI (T1), immediately post-intervention (T2), and 12-weeks post-intervention (LT)	Proportion of eligible employees (all, and according to license, sex/gender, race/ethnicity) who enroll and are willing to be randomized.
Number of participants that attended and completed the three assessment timepoints	BaselineI (T1), immediately post-intervention (T2), and 12-weeks post-intervention (LT)	Number of participants that attended and completed the three assessment timepoints
Retention rates at three assessment timepoints	BaselineI (T1), immediately post-intervention (T2), and 12-weeks post-intervention (LT)	Retention rates will be assessed at three assessment timepoints
Satisfaction score	Immediately post-intervention (T2), and 12-weeks post-intervention (LT)	The investigators will administer a satisfaction questionnaire that includes 5 questions. Total possible score ranges from 5-25. With higher score correlating with better study outcome.
Perceived credibility score	Immediately post-intervention (T2), and 12-weeks post-intervention (LT)	The investigators will assess perceived credibility with a questionnaire that includes 5 questions. Each question is scores from 1 to 8 with a total possible score range of 5-40. Higher score correlates with better study outcome.
Perceived intervention benefit	Immediately post-intervention (T2), and 12-weeks post-intervention (LT)	The investigators will assess perceived benefit with a questionnaire that includes 18 questions, to be answered with a 7-point scale. Total possible score ranges from 18 to 126. Higher score correlates with better study outcome.
Acceptability of wearing the Electronically Activated Recorder (EAR)	BaselineI (T1), immediately post-intervention (T2), and 12-weeks post-intervention (LT)	After the T1, T2, and LT assessments, participants will complete the EAR Experiential Questionnaire, a self-report measure that assesses the acceptability of wearing the EAR. Questions focus on participants' comfort with wearing the EAR, whether the EAR impeded daily activities, whether the EAR changed their behaviors or others' behaviors, and how typical were the days that the EAR was worn. Each question is rated on a Likert scale (1 "not at all" - 5 "a great deal"). Higher score correlates with better outcome.
Number of EMA dropouts	BaselineI (T1), immediately post-intervention (T2), and 12-weeks post-intervention (LT)	Number of EMA dropouts will be collected
Percentage (%) of items completed using EMA	BaselineI (T1), immediately post-intervention (T2), and 12-weeks post-intervention (LT)	Percentage of items completed using EMA will be assessed.

Secondary Outcome Measures

Name	Time	Method
Change in Agency for Healthcare Research and Quality's TeamSTEPPS ® Teamwork Perceptions Questionnaire (T-TPQ) score	BaselineI (T1), immediately post-intervention (T2), and 12-weeks post-intervention (LT)	Measures perceptions of team function with the administration of the Team Structure and Mutual Support subscales (14 items total). Total possible score ranges from 1-14 with higher scores indicating better outcome.
Change in Psychological safety scale score	BaselineI (T1), immediately post-intervention (T2), and 12-weeks post-intervention (LT)	Includes subscales measuring psychological safety with leaders, peers, and within the team (19 items). Total possible score ranges from 1-19 with higher scores indicating better outcome.
Change in Professional Fulfillment Index Score	BaselineI (T1), immediately post-intervention (T2), and 12-weeks post-intervention (LT)	Measures Professional fulfillment and burnout, and has demonstrated sensitivity to change in intervention studies (16 items). Total possible score ranges from 1-16 with higher scores indicating better outcome.
EMA (ecological momentary assessment) questionnaire score	BaselineI (T1), immediately post-intervention (T2), and 12-weeks post-intervention (LT)	The 3-day ambulatory questionnaire asks participants whether the ecological momentary assessment (EMA) impeded daily activities or changed their behaviors, rated on a Likert scale (1 "not at all" - 5 "a great deal"). Higher score correlates with better outcome.

Trial Locations

Locations (2)

Emory Winship Cancer Institute; 🇺🇸 Atlanta, Georgia, United States

Emory University St. Joseph hospital; 🇺🇸 Atlanta, Georgia, United States