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

Sponsor
M.D. Anderson Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT06127121
Collaborator
(none)
60
1
17.9
3.4

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Digital Art Activity

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

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A Digital Art Activity to Enhance Self-Disclosure and the Detection of Psycho-social Distress in Adult Cancer Patients
Actual Study Start Date :
Nov 2, 2023
Anticipated Primary Completion Date :
Apr 30, 2024
Anticipated Study Completion Date :
Apr 30, 2025

Arms and Interventions

Arm 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.

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

Outcome Measures

Primary Outcome Measures

  1. The Edmonton Symptom Assessment System, (ESAS) questionnaires [through study completion; an average 1 year.]

    Score Scale (0-10) 0 No symptom-10 Worst possible

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 MD Anderson Cancer Center Houston Texas United States 77030

Sponsors and Collaborators

  • M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Carlos Roldan, MD, M.D. Anderson Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT06127121
Other Study ID Numbers:
  • 2023-0328
  • NCI-2023-09557
First Posted:
Nov 13, 2023
Last Update Posted:
Nov 13, 2023
Last Verified:
Nov 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Nov 13, 2023