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| ID | Type | Description | Link |
|---|---|---|---|
| 1R34AT012509-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CCSH-TI Group | Experimental | 4-session intervention of 60- minutes each delivered every other week by healthcare chaplains to mixed-role inter-professional teams that includes mindfulness and compassion-based approaches to bolster resilience, compassion for self and others, and psychological safety. |
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| TAU (treatment as usual) group | Active Comparator | Participants in this group will have access to all well-being resources and activities available to them as employees. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Compassion Centered Spiritual Health Team Intervention (CCSH-TI) | Behavioral | Delivered to healthcare teams by spiritual health clinicians proficient in group facilitation. It is composed of 4 sessions delivered every other week and lasting 60 minutes each. CCSH-TI sessions teach participants to attune to their interpersonal relationships; acknowledge and allow difficult emotions; and access compassion. It also provides psychoeducation about skillful coping strategies. Each session consists of didactic material about team norms and safety, a feeling check-in, facilitated group discussions about social connection and professional team building, and meditations to promote mindfulness, to cultivate a feeling of being nurtured, and to access compassion for self and others. CCSH-TI is delivered to healthcare teams by spiritual health clinicians proficient in group facilitation. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of eligible employees who enroll and are willing to be randomized | Proportion of eligible employees (all, and according to license, sex/gender, race/ethnicity) who enroll and are willing to be randomized. | BaselineI (T1), immediately post-intervention (T2), and 12-weeks post-intervention (LT) |
| Number of participants that attended and completed the three assessment timepoints | Number of participants that attended and completed the three assessment timepoints | BaselineI (T1), immediately post-intervention (T2), and 12-weeks post-intervention (LT) |
| Retention rates at three assessment timepoints | Retention rates will be assessed at three assessment timepoints | BaselineI (T1), immediately post-intervention (T2), and 12-weeks post-intervention (LT) |
| Satisfaction score | 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. | Immediately post-intervention (T2), and 12-weeks post-intervention (LT) |
| Perceived credibility score | 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. | Immediately post-intervention (T2), and 12-weeks post-intervention (LT) |
| Perceived intervention benefit | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Agency for Healthcare Research and Quality's TeamSTEPPS ® Teamwork Perceptions Questionnaire (T-TPQ) score | 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. | BaselineI (T1), immediately post-intervention (T2), and 12-weeks post-intervention (LT) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Mascaro, PhD | Contact | 404-558-4461 | jmascar@emory.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jennifer Mascaro, PhD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory Winship Cancer Institute | Recruiting | Atlanta | Georgia | 30322 | United States | |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41258216 | Derived | Giordano NA, Kaplan DM, Peacock C, Vyas I, Pozzo N, Shelton M, Escoffery C, Rana S, Raison CL, Grant GH, Mascaro JS. Protocol to examine the feasibility and acceptability of a randomized controlled trial of a chaplain-delivered compassion intervention to improve psychological safety among interprofessional healthcare teams. Pilot Feasibility Stud. 2025 Nov 13;11(1):141. doi: 10.1186/s40814-025-01712-7. |
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The research team will share the molar and behavioral codebooks by uploading them to the Open Science Framework (OSF) EAR Repository, a publicly asses-sable collaborative repository of EAR, a resource co-maintained by a member of the research team (Kaplan). The investigator will share summarized rates of accrual, retention, intervention attendance, and self-reported data (mean, standard deviation, and range) at all 3 time-points.
Access will not be controlled or monitored; it will be made available by the data repository based on approval guidelines maintained by the repository itself.
Privacy and confidentiality will be protected using de-identification of all individual-level data. Audio recordings and transcripts will not be shared so as to maintain participant privacy.
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The scientific dataset will be shared at the time of associated publications and will be made available for as long as it is useful to the larger research community (i.e., in perpetuity).
All individual-level data sets will be shared in openICPSR.
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| ID | Term |
|---|---|
| D015438 | Health Behavior |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
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| D013812 | Therapeutics |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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This is a longitudinal, randomized pilot study of 80 employees working in inter-professional oncologic teams. Employees will be randomized by team (using a random number generator in Microsoft Excel) to receive CCSH-TI or to a TAU "treatment as usual" (TAU) group.
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| Treatment as Usual | Behavioral | TAU refers to the current buffet of wellness and professional development activities that are available to employees at the Winship Cancer Institute. |
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| Immediately post-intervention (T2), and 12-weeks post-intervention (LT) |
| Acceptability of wearing the Electronically Activated Recorder (EAR) | 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. | BaselineI (T1), immediately post-intervention (T2), and 12-weeks post-intervention (LT) |
| Number of EMA dropouts | Number of EMA dropouts will be collected | BaselineI (T1), immediately post-intervention (T2), and 12-weeks post-intervention (LT) |
| Percentage (%) of items completed using EMA | Percentage of items completed using EMA will be assessed. | BaselineI (T1), immediately post-intervention (T2), and 12-weeks post-intervention (LT) |
| Change in Psychological safety scale score | 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. | BaselineI (T1), immediately post-intervention (T2), and 12-weeks post-intervention (LT) |
| Change in Professional Fulfillment Index Score | 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. | BaselineI (T1), immediately post-intervention (T2), and 12-weeks post-intervention (LT) |
| EMA (ecological momentary assessment) questionnaire score | 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. | BaselineI (T1), immediately post-intervention (T2), and 12-weeks post-intervention (LT) |
| Emory University St. Joseph hospital |
| Recruiting |
| Atlanta |
| Georgia |
| 30342 |
| United States |