Clinical trial NCT04060901: Compassion-Centered Spiritual Health for Faculty and Staff
Official title: Compassion-Centered Spiritual Health (CCSH) Interventions for Teams With Faculty and Staff
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Behavior
Keywords: Spiritual health clinician
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2019-08-19
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: CRC teams will be randomized to one of two cohorts; the first cohort will receive the intervention during the first period while the second cohort waits to receive the intervention during the second period.
Primary purpose: PREVENTION

Brief summary: Compassion-Centered Spiritual Health (CCSH) at Emory University was launched as a joint creation by Spiritual Health and the Center for Contemplative Science and Compassion-Based Ethics in 2018. The program enhances the practice of spiritual health through CCSH Interventions, which are a Cognitively-Based Compassion Training (CBCT)-based approach to support the practices of spiritual health clinicians. CBCT is a research-based contemplative program developed at Emory University in 2004. CCSH Interventions are provided by spiritual health clinicians across Emory's inpatient and outpatient facilities and beyond, and offer a method to alleviate distress in patients and families and to mitigate burnout in healthcare professionals. While the intervention will be required for some staff and provider populations, Spiritual Health proposes to pilot a voluntary systematic implementation of CCSH Interventions for Teams (CCSH-TI) to clinical research teams at Winship Cancer Institute. Clinical Research Coordinators (CRCs) experience significant emotional and spiritual burden through exposure to patients living with cancer and undergoing clinical trials for cancer treatment. As individuals and teams, CRCs face multiple work-related challenges known to cause distress, including experiences of secondary trauma, exposure to emotional and spiritual suffering of patients and families, and experiences of loss of patients. The researchers of this study hope that offering CCSH Interventions for Teams to CRCs will increase their resilience, wellbeing and compassion toward self and others, with a secondary benefit that burnout will be reduced. By conducting this pilot project, the researchers hope to gain a better understanding of how to optimally implement CCSH for CRC teams at the Winship Cancer Institute.

Detailed description: Previous research indicates that Cognitively-Based Compassion Training (CBCT) improves empathic accuracy, enhances well-being, and attenuates the pro-inflammatory response to psychosocial stress. CBCT is a secularized compassion meditation program adapted from the Tibetan Buddhist mind training (lojong) tradition, and it may be an ideal addendum to the spiritual caregiving provided by Emory University hospital chaplains and chaplain residents to approximately 100,000 patients, staff, and faculty members each year.

With this in mind, The Emory University Spiritual Health department now incorporates CBCT into their training curriculum using a phased approach that began in Fall 2017. The Spiritual Health department also developed an adapted program based on CBCT principles that chaplains can then deliver to patients and staff, called Compassion-Centered Spiritual Health (CCSH). Spiritual Health proposes to pilot a systematic implementation of CCSH Interventions for Teams (CCSH-TI) to clinical research teams at the Winship Cancer Institute.

This is a randomized trial of CCSH Interventions for Teams versus a wait list control condition. CRC teams will be randomized to receive CCSH-TI during a first cohort or to a wait-list group that will receive CCSH-TI during the second cohort. CRCs (n = 93) will be randomized by team to receive CCSH Interventions for Teams either in the fall or in the spring. Participating CRCs will complete self-report measures at 4 timepoints throughout the year: (1) Prior to randomization, (2) immediately upon completion of CCSH Interventions for Teams for cohort 1 (3) prior to CCSH Interventions for Teams for cohort 2, and (4) immediately upon completion of CCSH Interventions for Teams for cohort 2.

Eligibility criteria: Inclusion Criteria:

* Emory staff, clinical research coordinators

Exclusion Criteria:

* None

Primary outcomes:
measure: Change in Professional Quality of Life (ProQOL) Score
timeFrame: Baseline, Week 5, Week 24, Week 29
measure: Staff Retention
timeFrame: Up to Week 29
measure: Staff Absenteeism
timeFrame: Up to Week 29
Secondary outcomes:
measure: Change in Depression Anxiety and Stress Scale (DASS) Short Form Score
timeFrame: Baseline, Week 5, Week 24, Week 29
measure: Change in Revised University of California, Los Angeles (UCLA) Loneliness Scale (R-UCLA) Score
timeFrame: Baseline, Week 5, Week 24, Week 29
measure: Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Short Form Score
timeFrame: Baseline, Week 5, Week 24, Week 29
measure: Change in Connor-Davidson Resilience Scale 25 (CD-RISC-25) Score
timeFrame: Baseline, Week 5, Week 24, Week 29
measure: Change in Nursing Incivility Scale (General, Nurse, and Patient subscales)
timeFrame: Baseline, Week 5, Week 24, Week 29
measure: Interest in the CCSH Intervention Scale
timeFrame: Baseline or Week 24
measure: Experiences with the CCSH Intervention Scale
timeFrame: Week 5 or Week 29
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University, Winship Cancer Institute
state: Georgia
Study officials:
affiliation: Emory University
name: Jennifer Mascaro, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mascaro JS, Palmer PK, Ash MJ, Peacock C, Sharma A, Escoffery C, Raison C. Feasibility, Acceptability, and Preliminary Effectiveness of a Compassion-Centered Team Intervention to Improve Clinical Research Coordinator Resilience and Well-Being. JCO Oncol Pract. 2021 Jul;17(7):e936-e946. doi: 10.1200/OP.21.00120. Epub 2021 Jun 21.