- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04557033
My Mindful Moments: A Mindfulness Meditation and Digital Art Activity
August 22, 2022 updated by: Theresa Jabaley, Dana-Farber Cancer Institute
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 .
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This project provides an opportunity for patient care staff in an ambulatory oncology setting to participate in and evaluate an activity that includes a mindfulness meditation technique and an expressive digital arts activity.
This study will be conducted to evaluate the feasibility of providing a mindfulness meditation and digital imagery activity.
- The activity will include a guided mindfulness meditation and the creation of a digital image on an iPad.
- Participants will be asked to complete brief surveys before and after the intervention activity.
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02215
- Dana Farber Cancer Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adults ≥18 years of age
- Currently employed at Dana Farber Cancer Institute
- Providing patient care on Yawkey
Exclusion Criteria:
- Not an employee of Dana Farber Cancer Institute
- Not providing Patient Care on Yawkey
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Mindful Meditation
|
My Moments® application (app) is a tool used to facilitate expressive art creation in a digital photography media
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage of Participation-Feasibility
Time Frame: 1 year
|
≥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
Time Frame: 1 year
|
> 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
Time Frame: 1 year
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Anxiety Score
Time Frame: 1 Year
|
Changes in participant state anxiety will be evaluated using the visual analogue scale in measuring state anxiety.
The electronic scale displays a horizontal line divided into 30 equal-sized partitions.
The left edge of the scale is marked "calm" and the right edge is marked "anxious."
A sliding locator is positioned at the midpoint of the scale.
The participant is instructed to use the computer mouse to place the locator at the scale position representing their current level of anxiety.
The score is automatically calculated by rounding the relative distance of the locator from the left edge of the scale to the nearest integer value between 0 and 30.
A higher score indicates greater anxiety.
A comparison of scores pre- and post- intervention by calculating a paired t-test comparison of means
|
1 Year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Terri Jabaley, Ph.D, RN, Dana-Farber Cancer Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2021
Primary Completion (Actual)
July 30, 2022
Study Completion (Actual)
July 30, 2022
Study Registration Dates
First Submitted
September 15, 2020
First Submitted That Met QC Criteria
September 15, 2020
First Posted (Actual)
September 21, 2020
Study Record Updates
Last Update Posted (Actual)
August 25, 2022
Last Update Submitted That Met QC Criteria
August 22, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 20-420
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
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.
IPD Sharing Time Frame
Data can be shared no earlier than 1 year following the date of publication
IPD Sharing Access Criteria
DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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