NCT04557033

Brief Summary

The purpose of this evidence-based practice project is to evaluate the feasibility of providing a relaxation mindfulness meditation and an expressive digital arts activity among clinical staff at Dana Farber Cancer Institute .

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2021

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

September 15, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 21, 2020

Completed
9 months until next milestone

Study Start

First participant enrolled

July 1, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2022

Completed
Last Updated

August 25, 2022

Status Verified

August 1, 2022

Enrollment Period

1.1 years

First QC Date

September 15, 2020

Last Update Submit

August 22, 2022

Conditions

Keywords

MindfulnessMeditation

Outcome Measures

Primary Outcomes (3)

  • Percentage of Participation-Feasibility

    ≥50% of staff choose to participate=Feasibility. This measure of feasibility will be evaluated by calculating index scores of the percentage of clinical staff who choose to participate

    1 year

  • Percentage Completion of Full Activity-Feasibility

    \> 80% of those who participate complete the activity=Feasibility. This measure of feasibility will be evaluated by index scores of the percentage of clinical staff who complete the full activity

    1 year

  • Mean Completion Time-Feasibility

    The activity is completed by the group in 40 minutes or less-Feasibility. This measure of feasibility will be evaluatedby individual group completions times and overall analysis of descriptive statistics on the time for completion of the activity by all groups.

    1 year

Secondary Outcomes (1)

  • Change in Anxiety Score

    1 Year

Study Arms (1)

Mindful Meditation

EXPERIMENTAL

* The activity will include a guided mindfulness meditation and the creation of a digital image on an iPad. * The My Moments® application (app) is a tool used to facilitate expressive art creation in a digital photography media * Participants will be asked to complete brief surveys before and after the intervention activity.

Other: Mindfulness intervention

Interventions

My Moments® application (app) is a tool used to facilitate expressive art creation in a digital photography media

Mindful Meditation

Eligibility Criteria

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

You may qualify if:

  • Adults ≥18 years of age
  • Currently employed at Dana Farber Cancer Institute
  • Providing patient care on Yawkey

You may not qualify if:

  • Not an employee of Dana Farber Cancer Institute
  • Not providing Patient Care on Yawkey

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Study Officials

  • Terri Jabaley, Ph.D, RN

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 15, 2020

First Posted

September 21, 2020

Study Start

July 1, 2021

Primary Completion

July 30, 2022

Study Completion

July 30, 2022

Last Updated

August 25, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will share

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Data can be shared no earlier than 1 year following the date of publication
Access Criteria
DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

Locations