## Protocol Section
### Identification Module
**NCT ID:** NCT06423183

**Acronym:** IMPACT

**Brief Title:** Interprofessional Mindfulness Practices Advancing Cancer Teamwork

**Official Title:** Interprofessional Mindfulness Practices Advancing Cancer Teamwork (IMPACT Study)

#### Organization Study ID Info
**ID:** 2024-0517
#### Organization
**Class:** OTHER
**Full Name:** University of Wisconsin, Madison
#### Secondary ID Infos
**Domain:** UW Madison
**ID:** A539713
**Type:** OTHER
**Domain:** UW Madison
**ID:** Protocol Version
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2025-06

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-21

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-15

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-06

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-21
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-15
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Wisconsin, Madison

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** The purpose of the research is to understand if mindfulness team training can improve the well-being and teamwork in caring for oncology patients. This study will enroll healthcare professionals in oncology teams, including clinic nurses, nurse managers, medical assistants, social workers, technicians, patient navigators, advanced practice providers, and physicians at UW Madison. Participants will be on study for up to approximately 6 months.

**Detailed Description:** Aim 1: Determine the effect of resilience training on team resilience and well-being. The investigators test the hypothesis that resilience training provided to interprofessional oncology care teams will improve team resilience and individual well-being.

Aim 2: Determine the feasibility and acceptability of a resilience training on team resilience. The investigators test the hypothesis that resilience training is feasible and acceptable in interprofessional oncology care teams.

### Conditions Module

**Conditions:**

- Burn Out

**Keywords:**

- oncology

- health care

- clinicians

- mindfulness

- well-being

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

**Intervention Model Description:** This study is a prospective, pre-post study at a single institution

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 50

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Behavioral: A Mindful Approach to Building a Resilient Healthcare Workforce (RENEW)

**Label:** Mindfulness-Based Team Resilience Training

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Mindfulness-Based Team Resilience Training

**Description:** Synchronous, 4-month intervention that teaches skills in mindfulness, stress management, and resilience as an individual and as a team. Sessions occur monthly and include a 1 hour in-person introductory session followed by 3 50-minute virtual sessions.

**Name:** A Mindful Approach to Building a Resilient Healthcare Workforce (RENEW)

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** 4-item Edmondson's psychology safety scale is scored on a likert scale from 1 (strongly disagree) to 7 (strongly agree), where higher scores indicate higher psychology safety

**Measure:** Change in Teamwork Measure

**Time Frame:** baseline (pre-intervention), post-intervention (3 months), follow up (6 months)

**Description:** Session 1 baseline, session 2 at 1 month, session 3 at 2 months, session 4 at 3 months

**Measure:** Number of Participants Who Attend Each Session

**Time Frame:** up to 3 months

**Description:** AIM is a 4-item survey scored on a 5 point likert scale from 1 (completely disagree) to 5 (completely agree), where higher scores indicate greater acceptability.

**Measure:** Acceptability of Intervention Measure (AIM)

**Time Frame:** up to 3 months

**Description:** IAM is a 4-item survey scored on a 5 point likert scale from 1 (completely disagree) to 5 (completely agree), where higher scores indicate greater appropriateness.

**Measure:** Intervention Appropriateness Measure (IAM)

**Time Frame:** up to 3 months

**Description:** FIM is a 4-item survey scored on a 5 point likert scale from 1 (completely disagree) to 5 (completely agree), where higher scores indicate greater feasibility.

**Measure:** Feasibility of Intervention Measure (FIM)

**Time Frame:** up to 3 months

#### Secondary Outcomes

**Description:** PSS is a 10-item survey scored from 0 (never) to 4 (very often) for a total possible range of scores from 0-40 where higher scores indicate higher perceived stress.

**Measure:** Change in Stress measured by Perceived Stress Scale (PSS)

**Time Frame:** baseline (pre-intervention), post-intervention (3 months), follow up (6 months)

**Description:** This is a 2-item survey scored from 0-6 where higher scores indicate increased burnout.

**Measure:** Change in Burnout measured by Maslach Burnout Inventory

**Time Frame:** baseline (pre-intervention), post-intervention (3 months), follow up (6 months)

**Description:** CD-RISC 2 is a 2-item survey each scored on a 5 point likert scale from 0 (not true at all) to 4 (true nearly all of the time), higher scores indicate increased resilience.

**Measure:** Change in Resilience measured by Connor Davidson Resilience Scale (CD-RISC 2)

**Time Frame:** baseline (pre-intervention), post-intervention (3 months), follow up (6 months)

**Description:** Flourishing measure is a 12-item survey that measure well being in each of 6 domains: happiness and life satisfaction; mental and physical health; meaning and purpose; character and virtue; close social relationships; financial and material stability. Each domain is scored from 0 - 10 where higher numbers are indicative of increased well being.

**Measure:** Change in Well-being measured by Flourishing Index

**Time Frame:** baseline (pre-intervention), post-intervention (3 months), follow up (6 months)

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* A care provider in an oncology clinic team (clinic nurse, nurse manager, medical assistant, technician, social worker, patient navigator, advanced practice provider, physician)

Exclusion Criteria:

* Does not participate in patient care or support services

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** stan75@wisc.edu

**Name:** Syndey Tan, MD

**Phone:** 608-263-7502

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Madison

**Country:** United States

**Facility:** UW Carbone Cancer Center

**State:** Wisconsin

**Zip:** 53792

#### Overall Officials

**Official 1:**

**Affiliation:** UW Carbone Cancer Center

**Name:** Lee Wilke, MD, FACS

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000013315

- Term: Stress, Psychological

- ID: D000001526

- Term: Behavioral Symptoms

### Condition Browse Module - Browse Branches

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: All

- Name: All Conditions

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

### Condition Browse Module - Browse Leaves

- ID: M5326

- Name: Burns

- Relevance: LOW

- As Found: Unknown

- ID: M1658

- Name: Burnout, Psychological

- Relevance: HIGH

- As Found: Burn Out

- ID: M16105

- Name: Stress, Psychological

- Relevance: LOW

- As Found: Unknown

- ID: M4818

- Name: Behavioral Symptoms

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000077062

- Term: Burnout, Psychological

### Misc Info Module

- Version Holder: 2024-05-31
