- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06789666
Digital Art Therapy for Young Cancer Survivors
Feasibility of a Digital Art Therapy Application Designed to Improve Quality of Life in Young Cancer Survivors
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Devin McCarthy
- Phone Number: 919-445-4208
- Email: devin_mccarthy@med.unc.edu
Study Contact Backup
- Name: Patricia Brock
- Phone Number: 919-962-8491
- Email: patriciabrock@med.unc.edu
Study Locations
-
-
North Carolina
-
Chapel Hill, North Carolina, United States, 27599
- Recruiting
- Lineberger Comprehensive Cancer Center
-
Contact:
- Devine McCarthy
- Phone Number: 919-445-4208
- Email: devin_mccarthy@med.unc.edu
-
Contact:
- Patricia Brock
- Phone Number: +1 919-962-8491
- Email: patricia_brock@med.unc.edu
-
Principal Investigator:
- Soma Sengupta, MD
-
Sub-Investigator:
- Bridget Pemberton-Smith, LLC
-
Sub-Investigator:
- Zev Nakamura, MD
-
Sub-Investigator:
- Claudia Rebola
-
Sub-Investigator:
- Heekyoung Jung
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
In order to participate in this study a subject must meet all of the eligibility criteria outlined below.
- Written informed assent and parental consent obtained to participate in the study and HIPAA authorization for release of personal health information.
- Subject is willing and able to comply with study procedures based on the judgment of the investigator.
- Age 18-25 years at the time of consent.
- Childhood cancer survivor, defined as having cancer between birth 17 years of age and who has completed cancer treatment.
- Reliable internet connection and access to a computer, smartphone, or iPad to support application and virtual study visits.
- Answers "yes" to the question "Do you experience mood issues (yes or no)?".
Exclusion Criteria:
- All subjects meeting any of the exclusion criteria at baseline will be excluded from study participation.
- Patients who lack interest in art. Screening question: Are you open to making art on a scale from 1-5 (1 being not at all, and 5 being very much; must score 3 or higher).
- Subjects who lack basic technology skills (Screening question: On a scale of 1-5 (1 being uncomfortable, and 5 being very comfortable), how would you rate your comfort using websites. Must score 3 or higher).
- Subjects unable to provide consent.
- Other conditions or factors which in the opinion of the Pl would not make the patient a good candidate for the study.
Study Plan
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: Digital Art Therapy
All participants will receive art therapy via the ARTCan App for 6 weeks, and will also be prompted to complete mental health quality of life surveys at baseline and each week, which will be available for the therapist to review.
|
The ARTCan App is an art therapy technology application program. The application can be accessed via the web (via computer, phone, or on a device such as an iPad). With the use of the application, participants complete weekly sessions that culminate in an "art" piece. Note that participants are not required to have expertise in drawing; developing art skills or assessing the quality of art pieces is not the focus of the ARTCan program. Subjects will upload a photo of the art they created to this application to show proof of completion of art therapy. They will also answer questions specific to the art therapy theme for the week. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility of art therapy
Time Frame: Up to 6 weeks
|
The feasibility of art therapy will be determined by the proportion of participants who complete art therapy.
The proportion of participants who complete 4 of the 6 art therapy modules will be determined.
A completion rate of 10 out of 15 participants will be deemed feasible.
|
Up to 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Acceptability of art therapy
Time Frame: at 6 week
|
Acceptability of art therapy will be measured as the proportion of participants responded to the survey questionnaire administered at the end of the intervention.
The survey questionnaire will be taken via a web-based application as post- Intervention Assessment.
Question: 1) Please provide your impression of the ARTCan App: A) I like the App B) I don't like the.
|
at 6 week
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Soma Sengupta, MD, UNC Lineberger Comprehensive Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LCCC2339
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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