- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06127121
A Digital Art Activity to Enhance Self-Disclosure and the Detection of Psycho-social Distress in Adult Cancer Patients
Study Overview
Detailed Description
Primary objective:
- To evaluate how engaging in a digital art activity might potentially cause changes in symptom reporting, based on pre/post self-reporting on the Edmonton Symptom Assessment System (ESAS) at time T3.
Secondary objectives:
- To evaluate the changes in symptom reporting, based on pre/post self-reporting on ESAS at different times of the study (T1, T2).
- To evaluate how a specific creative art making activity (T3), compared to an active control condition (T2; music listening) may or may not impact reporting ESAS.
- To monitor potential changes in distress disclosure, based on the self-report scoring on the Distress Disclosure Index score at T0, T2 and T3.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Carlos Roldan, MD
- Phone Number: (713) 563-7402
- Email: croldan@mdanderson.org
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- Recruiting
- MD Anderson Cancer Center
-
Contact:
- Carlos Roldan, MD
- Phone Number: 713-563-7402
- Email: croldan@mdanderson.org
-
Principal Investigator:
- Carlos Roldan, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age equal or greater than 18 years
- Patients who are admitted in the hospital and have received a cancer diagnosis.
- Suffering from solid cancer or hematological malignancy and receiving active treatment for their cancer.
- Voluntary written consent.
- Fluent in English or Spanish.
Exclusion Criteria:
- Not being able to use a digital tablet
- Being speech impaired or vision impaired
- Patients who are cognitively impaired and unable to read or consent for the study
- Pregnant women
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Digital Art Activity
Visit 1, Participants will be asked to complete a symptom questionnaire and then you will interact with the digital art tool. Participants will first complete a short breathing exercise, and then Participants will interact with the digital art tool. The digital tool combines a digital canvas with a collage activity. Participants will be asked to choose a background and then answer questions about your general well-being and your physical and emotional symptoms as they relate to cancer and cancer treatment. Visit 2, Participants will be asked to fill out the symptom questionnaire, complete another activity such as listening to meditative music for 10 minutes, and then fill out the symptom questionnaire again. Visit 3, Participants will fill out the symptom questionnaire and engage in the digital art activity again. Participants will then be asked to fill out 3 other questionnaires about your feelings of distress. |
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Edmonton Symptom Assessment System, (ESAS) questionnaires
Time Frame: through study completion; an average 1 year.
|
Score Scale (0-10) 0 No symptom-10 Worst possible
|
through study completion; an average 1 year.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Carlos Roldan, MD, M.D. Anderson 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 (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023-0328
- NCI-2023-09557 (Other Identifier: NCI-CTRP Clinical Trials Registry)
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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