NCT06423183

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2024

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

May 15, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 21, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

September 26, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

February 13, 2025

Status Verified

February 1, 2025

Enrollment Period

3 months

First QC Date

May 15, 2024

Last Update Submit

February 10, 2025

Conditions

Keywords

oncologyhealth carecliniciansmindfulnesswell-being

Outcome Measures

Primary Outcomes (5)

  • 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

    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

    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.

    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.

    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.

    up to 3 months

Secondary Outcomes (4)

  • Change in Stress measured by Perceived Stress Scale (PSS)

    baseline (pre-intervention), post-intervention (3 months), follow up (6 months)

  • Change in Burnout measured by Maslach Burnout Inventory

    baseline (pre-intervention), post-intervention (3 months), follow up (6 months)

  • Change in Resilience measured by Connor Davidson Resilience Scale (CD-RISC 2)

    baseline (pre-intervention), post-intervention (3 months), follow up (6 months)

  • Change in Well-being measured by Flourishing Index

    baseline (pre-intervention), post-intervention (3 months), follow up (6 months)

Study Arms (1)

Mindfulness-Based Team Resilience Training

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

Interventions

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.

Mindfulness-Based Team Resilience Training

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • Does not participate in patient care or support services

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UW Carbone Cancer Center

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Burnout, PsychologicalNeoplasms

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Lee Wilke, MD, FACS

    UW Carbone Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: This study is a prospective, pre-post study at a single institution
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2024

First Posted

May 21, 2024

Study Start

September 26, 2024

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

February 13, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations