A Digital Art Activity to Enhance Self-Disclosure and the Detection of Psycho-social Distress in Adult Cancer Patients

Cancer Clinical Trial

Official title:

A Digital Art Activity to Enhance Self-Disclosure and the Detection of Psycho-social Distress in Adult Cancer Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06127121
• Other study ID #: 2023-0328
• Secondary ID: NCI-2023-09557
• Status: Recruiting
• Start date: November 2, 2023
• Est. completion date: August 31, 2025

Study information

• Verified date: June 2024
• Source: M.D. Anderson Cancer Center
• Contact: Carlos Roldan, MD
• Phone: (713) 563-7402
• Email: croldan[@]mdanderson.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To look at how a digital art activity may help cancer patients improve their ability to express their distress, symptoms, and lived experience.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 31, 2025
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age equal or greater than 18 years

2. Patients who are admitted in the hospital and have received a cancer diagnosis within six months to one year of the study.

3. Suffering from colorectal cancer, breast cancer, pancreatic cancer or lung cancer and receiving active treatment for their cancer.

4. Voluntary written consent.

5. Fluent in English or Spanish.

Exclusion Criteria:

1. Not being able to use a digital tablet

2. Being speech impaired or vision impaired

3. Patients who are cognitively impaired and unable to read or consent for the study

4. Pregnant women

Related Conditions & MeSH terms

• Cancer

Intervention

Behavioral:
• Digital Art Activity
complete a symptom questionnaire complete another activity such as listening to meditative music for 10 minutes fill out the symptom questionnaire and engage in the digital art activity again

Locations

Country	Name	City	State
United States	MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Edmonton Symptom Assessment System, (ESAS) questionnaires	Score Scale (0-10) 0 No symptom-10 Worst possible	through study completion; an average 1 year.

External Links

•   M D Anderson Cancer Center