Burn OutIMPACTNCT06423183
Interprofessional Mindfulness Practices Advancing Cancer Teamwork
A study testing A Mindful Approach to Building a Resilient Healthcare Workforce (RENEW) in people with Burn Out, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Burn Out
- What is being tested?
- A Mindful Approach to Building a Resilient Healthcare Workforce (RENEW)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Sep 2024to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- A care provider in an oncology clinic team (clinic nurse, nurse manager, medical assistant, technician, social worker, patient navigator, advanced practice provider, physician)
Who cannot join
- Does not participate in patient care or support services
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interprofessional Mindfulness Practices Advancing Cancer Teamwork (IMPACT Study)
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.
Read the 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
- Burn Out
- Being tested
- A Mindful Approach to Building a Resilient Healthcare Workforce (RENEW)
- Keywords
- oncology, health care, clinicians, mindfulness, well-being
- Medical subject headings
- Burnout, Psychological, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A Mindful Approach to Building a Resilient Healthcare Workforce (RENEW)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-Based Team Resilience Training | Experimental | Not described Receives: Behavioral: A Mindful Approach to Building a Resilient Healthcare Workforce (RENEW) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Teamwork Measure
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
Measured: baseline (pre-intervention), post-intervention (3 months), follow up (6 months)
Number of Participants Who Attend Each Session
Session 1 baseline, session 2 at 1 month, session 3 at 2 months, session 4 at 3 months
Measured: up to 3 months
Acceptability of Intervention Measure (AIM)
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.
Measured: up to 3 months
Intervention Appropriateness Measure (IAM)
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.
Measured: up to 3 months
Feasibility of Intervention Measure (FIM)
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.
Measured: up to 3 months
Secondary outcomes (4)
Change in Stress measured by Perceived Stress Scale (PSS)
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.
Measured: baseline (pre-intervention), post-intervention (3 months), follow up (6 months)
Change in Burnout measured by Maslach Burnout Inventory
This is a 2-item survey scored from 0-6 where higher scores indicate increased burnout.
Measured: baseline (pre-intervention), post-intervention (3 months), follow up (6 months)
Change in Resilience measured by Connor Davidson Resilience Scale (CD-RISC 2)
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.
Measured: baseline (pre-intervention), post-intervention (3 months), follow up (6 months)
Change in Well-being measured by Flourishing Index
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.
Measured: baseline (pre-intervention), post-intervention (3 months), follow up (6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2024
- Study start26 Sep 2024
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burn OutStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study is a prospective, pre-post study at a single institution
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lee Wilke, MD, FACS, Principal investigator, UW Carbone Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06423183
- Sponsor's protocol ID
- 2024-0517
- Other IDs
- A539713, Protocol Version 6/17/2024, UW24074
- Acronym
- IMPACT
- Status last verified
- Feb 2025
- First submitted
- 15 May 2024
- Last updated
- 13 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interprofessional Mindfulness Practices Advancing Cancer Teamwork (IMPACT Study)
- ClinicalTrials.gov ID
- NCT06423183
- Acronym / sponsor ID
- IMPACT / 2024-0517
- Conditions
- Burn Out
- Keywords
- oncology, health care, clinicians, mindfulness, well-being
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 26 Sep 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 21 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study is a prospective, pre-post study at a single institution
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-Based Team Resilience Training | Experimental | Behavioral: A Mindful Approach to Building a Resilient Healthcare Workforce (RENEW) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- A care provider in an oncology clinic team (clinic nurse, nurse manager, medical assistant, technician, social worker, patient navigator, advanced practice provider, physician)
Key exclusion criteria (1 listed)
- Does not participate in patient care or support services
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A Mindful Approach to Building a Resilient Healthcare Workforce (RENEW)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. | Behavioural | Mindfulness-Based Team Resilience Training |
Primary outcome
Change in Teamwork Measure
Time frame: baseline (pre-intervention), post-intervention (3 months), follow up (6 months)
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
Number of Participants Who Attend Each Session
Time frame: up to 3 months
Session 1 baseline, session 2 at 1 month, session 3 at 2 months, session 4 at 3 months
Acceptability of Intervention Measure (AIM)
Time frame: up to 3 months
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.
Intervention Appropriateness Measure (IAM)
Time frame: up to 3 months
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.
Feasibility of Intervention Measure (FIM)
Time frame: up to 3 months
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.
4 secondary outcomes
Change in Stress measured by Perceived Stress Scale (PSS)
Time frame: baseline (pre-intervention), post-intervention (3 months), follow up (6 months)
Change in Burnout measured by Maslach Burnout Inventory
Time frame: baseline (pre-intervention), post-intervention (3 months), follow up (6 months)
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)
Change in Well-being measured by Flourishing Index
Time frame: baseline (pre-intervention), post-intervention (3 months), follow up (6 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lee Wilke, MD, FACS principal investigator
UW Carbone Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A Mindful Approach to Building a Resilient Healthcare Workforce (RENEW) in people with Burn Out, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Teamwork Measure (time frame: baseline (pre-intervention), post-intervention (3 months), follow up (6 months)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025; AzTrials last refreshed its copy on 29 Oct 2026.