Digital Art Therapy for Young Cancer Survivors

Study Purpose

This is a single-site, single-arm, interventional study assessing the feasibility of the ARTCan Therapy Application (App) and whether it is an acceptable means of administering art therapy to young adult cancer survivors. The ARTCan Therapy App guides participants through a 6-week digital art therapy program. Subjects will participate in weekly art therapy prompts guided by the app and will complete weekly mental health quality of life (MHQoL) surveys during the intervention. In addition, baseline and end-of-intervention patient-reported outcome measures (PROMIS-DSF8a) and an acceptability survey will be administered. The hypothesis is that digital art therapy is feasible for young adult cancer survivors with self-reported mood issues and is an acceptable means of administering art therapy in the patient population.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 25 Years
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06789666
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

UNC Lineberger Comprehensive Cancer Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Soma Sengupta, MD
Principal Investigator Affiliation UNC Lineberger Comprehensive Cancer Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Cancer, Pediatric Cancer, Pediatric Malignancies, Pediatric Sarcoma of Soft Tissue, Adolescent and Young Adult With Brain Cancer
Study Website: View Trial Website
Additional Details

The ARTCan application has been designed to define therapy strategies for the care of patients; it emerges from a unique collaboration in the disciplines of design, art, art therapy, and medicine from the College of Design, Architecture, Art, and Planning (DAAP) at the University of Cincinnati (UC) and the School of Medicine, the University of North Carolina, Chapel Hill. The relevance of the application design was to enable the trans-disciplinary team to experiment with proof of the following concepts: 1) technology-based tools and feasibility studies for new lines of research in treatment; 2) research that embraces intellectual diversity by merging the creative disciplines; and 3) addressing issues of health and well-being of patients. This study is testing whether the digital art therapy application "Art Therapy Can Do" (ARTCan) is a feasible means of administering art therapy to young cancer survivors. The study is funded by the Ian's Friends Foundation and the Weatherspoon Foundation.

Arms & Interventions

Arms

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.

Interventions

Behavioral: - ARTCan App

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina

Status

Address

Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599

Site Contact

Devine McCarthy

[email protected]

919-445-4208

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