NCT06789666

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable cancer

Timeline
8mo left

Started Apr 2025

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress67%
Apr 2025Apr 2027

First Submitted

Initial submission to the registry

January 17, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 23, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

April 7, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

September 16, 2025

Status Verified

September 1, 2025

Enrollment Period

2 years

First QC Date

January 17, 2025

Last Update Submit

September 15, 2025

Conditions

Keywords

therapyartmental health quality of lifepatient-reported outcomeARTCan applicationdigital art therapy

Outcome Measures

Primary Outcomes (1)

  • Feasibility of art therapy

    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 Outcomes (1)

  • Acceptability of art therapy

    at 6 week

Study Arms (1)

Digital Art Therapy

EXPERIMENTAL

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.

Behavioral: ARTCan App

Interventions

ARTCan AppBEHAVIORAL

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.

Digital Art Therapy

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)?".

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Soma Sengupta, MD

    UNC Lineberger Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2025

First Posted

January 23, 2025

Study Start

April 7, 2025

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Last Updated

September 16, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations