CancerNCT06127121
A Digital Art Activity to Enhance Self-Disclosure and the Detection of Psycho-social Distress in Adult Cancer Patients
An observational study of Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Digital Art Activity
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Nov 2023to 31 Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: M D Anderson Cancer Center
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
To look at how a digital art activity may help cancer patients improve their ability to express their distress, symptoms, and lived experience.
Read the 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.
- Conditions
- Cancer
- Being tested
- Digital Art Activity
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Art ActivityBehavioural
- 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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Digital Art Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Edmonton Symptom Assessment System, (ESAS) questionnaires
Score Scale (0-10) 0 No symptom-10 Worst possible
Measured: through study completion; an average 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start2 Nov 2023
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carlos Roldan, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06127121
- Sponsor's protocol ID
- 2023-0328
- Other IDs
- NCI-2023-09557
- Status last verified
- Aug 2026
- First submitted
- 7 Nov 2023
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Digital Art Activity to Enhance Self-Disclosure and the Detection of Psycho-social Distress in Adult Cancer Patients
- ClinicalTrials.gov ID
- NCT06127121
- Acronym / sponsor ID
- 2023-0328
- Conditions
- Cancer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 74 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 2 Nov 2023 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 13 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Digital Art Activity | – | Behavioral: Digital Art ActivityVisit 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- M D Anderson Cancer Center
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Behavioural | Digital Art Activity |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- M D Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos Roldan, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Edmonton Symptom Assessment System, (ESAS) questionnaires (time frame: through study completion; an average 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.