NCT04060901

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 19, 2019

Completed
4 days until next milestone

Study Start

First participant enrolled

August 23, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 7, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 7, 2020

Completed
Last Updated

May 14, 2020

Status Verified

May 1, 2020

Enrollment Period

6 months

First QC Date

August 16, 2019

Last Update Submit

May 12, 2020

Conditions

Keywords

Spiritual health clinician

Outcome Measures

Primary Outcomes (3)

  • Change in Professional Quality of Life (ProQOL) Score

    The Professional Quality of Life Scale (ProQOL) is a 30-item inventory and is the most commonly used measure of the negative and positive effects of helping others who experience suffering. It has sub-scales for compassion satisfaction, burnout, and compassion fatigue. The sub-scales are summed and converted to t-scores with a mean of 50 and standard deviation of 10. Scores higher than 57 indicate professional satisfaction while scores below 40 indicate possible problems with feeling satisfied professionally.

    Baseline, Week 5, Week 24, Week 29

  • Staff Retention

    Staff retention (number of employees not resigning) will be compared between the teams completing the intervention and those who have not yet participated.

    Up to Week 29

  • Staff Absenteeism

    Staff absenteeism (number of missed work days) will be compared between the teams completing the intervention and those who have not yet participated.

    Up to Week 29

Secondary Outcomes (7)

  • Change in Depression Anxiety and Stress Scale (DASS) Short Form Score

    Baseline, Week 5, Week 24, Week 29

  • Change in Revised University of California, Los Angeles (UCLA) Loneliness Scale (R-UCLA) Score

    Baseline, Week 5, Week 24, Week 29

  • Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Short Form Score

    Baseline, Week 5, Week 24, Week 29

  • Change in Connor-Davidson Resilience Scale 25 (CD-RISC-25) Score

    Baseline, Week 5, Week 24, Week 29

  • Change in Nursing Incivility Scale (General, Nurse, and Patient subscales)

    Baseline, Week 5, Week 24, Week 29

  • +2 more secondary outcomes

Study Arms (2)

CCSH Interventions for Teams in Cohort 1

EXPERIMENTAL

Participants in the first cohort will receive the CCSH Interventions for Teams during the fall session (first intervention period).

Behavioral: CCSH Intervention for Teams

CCSH Interventions for Teams in Cohort 2

EXPERIMENTAL

Participants in the second cohort will receive the CCSH Interventions for Teams during the spring session (second intervention period).

Behavioral: CCSH Intervention for Teams

Interventions

CCSH Interventions for Teams will be a six session intervention. The groups meet once per week for 60 minutes for 4 weeks, coupled with 2 booster sessions over the following 2 months. Participants will receive the CCSH interventional approach, adapted for a group setting, which follows four stages: 1) Preparing the care responder; 2) Attuning to the Relationship; 3) Accessing Compassion, and 4) Entrusting the Careseeker. The CCSH approach will be used to assess group dynamics, individual member sources of distress, as well as existing resources for resilience and compassion. Through the intervention, resources will then be identified and accessed in order to respond to team (and individual) sources of distress with greater resilience and increased compassion toward self and others. CCSH clinicians will utilize group process skills to encourage team communication about work-related challenges, enhance team cohesion, and enable interpersonal support among members of the team.

CCSH Interventions for Teams in Cohort 1CCSH Interventions for Teams in Cohort 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Emory staff, clinical research coordinators

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emory University, Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Jennifer Mascaro, PhD

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 16, 2019

First Posted

August 19, 2019

Study Start

August 23, 2019

Primary Completion

February 7, 2020

Study Completion

February 7, 2020

Last Updated

May 14, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations