- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03291730
A Nurse Led Project to Introduce Hand Lettering as a Form of Creative Art Expression to Patients in an Ambulatory Oncology Setting
November 29, 2018 updated by: Cindy L. Cao, Dana-Farber Cancer Institute
The investigators are conducting a project to provide a new type of resource called "hand lettering" to patients receiving chemotherapy.
This is a type of art therapy.
The goal of this project is to understand if it is feasible to use art-therapy and to describe anxiety before and after completing hand-lettering.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study is being done to understand if it is feasible to use a form of art-therapy called hand-lettering at Dana-Farber Cancer Institute.
We would also like to explore the anxiety a person has before and after using hand-lettering.
Study Type
Interventional
Enrollment (Actual)
22
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, 02115
- 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
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adult patients (>age 18) with a cancer diagnosis receiving oral or IV chemotherapy at Dana-Farber on Yawkey 10.
- Able to read and speak English
- Has a minimum appointment time of 60 minutes
Exclusion Criteria:
-Individuals with visual impairment or blindness will be excluded
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: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Hand Lettering
|
May help reduce anxiety of receiving chemotherapy
May help reduce anxiety of receiving chemotherapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluate the feasibility of implementing nurse-led hand-lettering in an ambulatory infusion setting
Time Frame: 2 years
|
Feasibility will be defined through enrollment and completion rates.
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Describe patient self-reported anxiety before and after utilizing hand-lettering
Time Frame: 2 years
|
Anxiety measured through the State Trait Anxiety Index.
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Cindy L Cao, 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)
January 9, 2018
Primary Completion (ACTUAL)
June 5, 2018
Study Completion (ACTUAL)
June 5, 2018
Study Registration Dates
First Submitted
September 20, 2017
First Submitted That Met QC Criteria
September 20, 2017
First Posted (ACTUAL)
September 25, 2017
Study Record Updates
Last Update Posted (ACTUAL)
December 3, 2018
Last Update Submitted That Met QC Criteria
November 29, 2018
Last Verified
November 1, 2018
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 17-377
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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