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

NCT ID: NCT06127121

Last Updated: 2025-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-02

Study Completion Date

2027-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Digital Art Activity

Intervention Type BEHAVIORAL

* 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Age equal or greater than 18 years
2. Patients who are admitted in the hospital and have received a cancer diagnosis.
3. Suffering from solid cancer or hematological malignancy 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Carlos Roldan, MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

MD Anderson Cancer Center

Houston, Texas, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Carlos Roldan, MD

Role: CONTACT

(713) 563-7402

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Carlos Roldan, MD

Role: primary

713-563-7402

Related Links

Access external resources that provide additional context or updates about the study.

http://www.mdanderson.org

M D Anderson Cancer Center

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NCI-2023-09557

Identifier Type: OTHER

Identifier Source: secondary_id

2023-0328

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Personality and Cancer Care Study
NCT04625439 COMPLETED NA