Hematopoietic and Lymphatic System NeoplasmNCT06342453
CREATE: Art for Children With Cancer
A study testing Art Therapy, Discussion and Media Intervention in people with Hematopoietic and Lymphatic System Neoplasm and Malignant Solid Neoplasm, run by OHSU Knight Cancer Institute at 1 site in United States.
Trial summary
This clinical trial is being done to develop and test how well creative arts interventions (drawing, painting, making sculptures) compared to watching videos can affect symptoms and impact the quality of life in children with cancer. Read more about this study
- Who is it for?
- Ages 8 to 13 years
- Conditions the study is for
- Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
- What is being tested?
- Art Therapy, Discussion and Media Intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jun 2024to 31 Dec 2027
- Phase
- Interventional
- 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 8 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Aged 8 to 13 years of age
- Have been diagnosed with cancer of any type in the prior 12 months
- Be English literate (we will amend this criterium when the study surveys are validated in Spanish). Parent/caregiver of child participant may be Spanish speaking
- Physically and cognitively able to participate in creative arts
- Expected to receive enough treatment at local site to participate in all four intervention sessions
Who cannot join
- Not English literate
- Otherwise unable to complete study procedures
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
OHSU Knight Cancer Institute
Portland, Oregon, 97239
Jennifer L. Raybin, 503-418-5150, raybin@ohsu.edu
Jennifer L. Raybin
About this study
Official title: CREATE: Clinical Research Examining the Arts as Targeted Elements in Childhood Cancer Care
This clinical trial is being done to develop and test how well creative arts interventions (drawing, painting, making sculptures) compared to watching videos can affect symptoms and impact the quality of life in children with cancer. Creative arts mind-body interventions (CrA) are one type of complementary health interventions which have been associated with improved quality of life and reduced symptom burden among children with cancer. CrA is an ideal intervention for children with cancer due to the long hours spent in the hospital setting for treatments, the creativity and developmental focus of children, and their potential ability to communicate more easily through art than words. Researchers want to develop and test a CrA intervention to help improve symptoms and the quality of life of children with cancer.
Read the detailed description
PRIMARY OBJECTIVE:
- Feasibility of an randomized controlled trial (RCT) of art among children with cancer.
SECONDARY OBJECTIVES:
- Achieve recruitment rate target. II. Achieve accrual target. III. Achieve fidelity to intervention. IV. Assess initial effect sizes.
OUTLINE:
PHASE I: Patients participate in focus groups to develop CrA intervention on study.
PHASE II: Patients are randomized to 1 of 2 arms.
ARM I: Patients participate in CrA interventions comprising drawing, painting, and making sculptures with a trained artist for 30 minutes once a week for 4 sessions over 12 weeks.
ARM II: Patients passively watch videos for 30 minutes once a week for 4 sessions over 12 weeks.
- Being tested
- Art Therapy, Discussion, Media Intervention, Survey Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Art TherapyProcedure or surgery
Participate in CrA
DiscussionProcedure or surgery
Also called Discuss, creating art
Participate in art focus group, art-making
Media InterventionOther
Watch videos
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Phase I (focus group) | Active comparator | Patients participate in focus groups to develop CrA intervention on study. Receives: Procedure: Discussion; Other: Survey Administration |
| Phase II arm I (CrA) | Experimental | Patients participate in CrA interventions comprising drawing, painting, and making sculptures with a trained artist for 30 minutes once a week for 4 sessions over 12 weeks. Receives: Procedure: Art Therapy; Other: Survey Administration |
| Phase II arm II (watch videos) | Active comparator | Patients passively watch videos for 30 minutes once a week for 4 sessions over 12 weeks. Receives: Other: Media Intervention; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants that complete all interventions and data collection time points
Will be considered feasible if 80% of participants complete 4 intervention sessions and 3 data collection time points. Will be summarized across and within each study arm using means and standard deviations for continuous variables, and frequency counts and percentages for nominal variables.
Measured: Up to day 90
Secondary outcomes (6)
Number of eligible participants that enroll in the study (feasibility threshold of 80%)
Will use 95% confidence intervals to estimate the precision of all point estimates.
Measured: Up to to 24 months
Number of participants that complete all interventions and all surveys in the study.
Goal of 80% of recruited participants. Will use 95% confidence intervals to estimate the precision of all point estimates.
Measured: Up to 24 months
Number of intervenor fidelity surveys that obtain at least 95% score.
Will use 95% confidence intervals to estimate the precision of all point estimates.
Measured: Up to 24 months
Comparison of scores on the PRO-CTCAE between intervention arms
Will use National Cancer Institute's Pediatric Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). The PRO-CTCAE Measurement System characterizes the frequency, severity, interference, and presence/absence of symptomatic toxicities. Answers ranging from None to Very Severe (none=0 to very severe=4); Not at All to Very Much (not at all=0 to very much=4), Never to Almost Constantly (0=never to almost constantly=4). Will be assessed by comparing outcome measure results between arms. Will use 95% confidence intervals to estimate the precision of all point estimates.
Measured: Up to 24 months
Comparison of scores on the PROMIS between intervention arms
Will use PROMIS Pediatric Global Health-7 measure, a brief 7-item summary assessment of a child's self-reported health. This measure contains 7 items assessing global health (physical and mental wellbeing. All items are completed on a 5-point Likert scale (1= Poor to 5 = Excellent, or 1 = Never to 5 = Always or Almost always, depending on the domain). Will be assessed by comparing outcome measure results between arms. Will use 95% confidence intervals to estimate the precision of all point estimates.
Measured: Up to 24 months
Comparison of scores on the Faces between intervention arms
Will be assessed using a Faces scale with 9 faces in order of happy to sad to assess emotional reactions. Will be assessed by comparing outcome measure results between arms. Will use 95% confidence intervals to estimate the precision of all point estimates.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start4 Jun 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic and Lymphatic System NeoplasmStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OHSU Knight Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Oregon Health and Science University, National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Jenny Raybin, OHSU Knight Cancer Institute
- Investigators
- Jennifer L Raybin, PhD RN, Principal investigator, OHSU Knight Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06342453
- Sponsor's protocol ID
- STUDY00026814
- Other IDs
- R34AT012497, NCI-2024-01534, STUDY00026814
- Status last verified
- Aug 2026
- First submitted
- 5 Mar 2024
- Last updated
- 25 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Will share by publishing in an ICMJE journal and will also submit data and metadata to the Dyad data repository.
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CREATE: Clinical Research Examining the Arts as Targeted Elements in Childhood Cancer Care
- ClinicalTrials.gov ID
- NCT06342453
- Acronym / sponsor ID
- STUDY00026814
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- OHSU Knight Cancer InstituteUniversity, hospital or other
- Collaborators
- Oregon Health and Science University, National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 4 Jun 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 2 Apr 2024 (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.
This clinical trial is being done to develop and test how well creative arts interventions (drawing, painting, making sculptures) compared to watching videos can affect symptoms and impact the quality of life in children with cancer. Creative arts mind-body interventions (CrA) are one type of complementary health interventions which have been associated with improved quality of life and reduced symptom burden among children with cancer. CrA is an ideal intervention for children with cancer due to the long hours spent in the hospital setting for treatments, the creativity and developmental focus of children, and their potential ability to communicate more easily through art than words. Researchers want to develop and test a CrA intervention to help improve symptoms and the quality of life of children with cancer.
Detailed description
PRIMARY OBJECTIVE:
- Feasibility of an randomized controlled trial (RCT) of art among children with cancer.
SECONDARY OBJECTIVES:
- Achieve recruitment rate target. II. Achieve accrual target. III. Achieve fidelity to intervention. IV. Assess initial effect sizes.
OUTLINE:
PHASE I: Patients participate in focus groups to develop CrA intervention on study.
PHASE II: Patients are randomized to 1 of 2 arms.
ARM I: Patients participate in CrA interventions comprising drawing, painting, and making sculptures with a trained artist for 30 minutes once a week for 4 sessions over 12 weeks.
ARM II: Patients passively watch videos for 30 minutes once a week for 4 sessions over 12 weeks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase I (focus group) | Active comparator | Procedure: Discussion, Other: Survey AdministrationPatients participate in focus groups to develop CrA intervention on study. |
| Phase II arm I (CrA) | Experimental | Procedure: Art Therapy, Other: Survey AdministrationPatients participate in CrA interventions comprising drawing, painting, and making sculptures with a trained artist for 30 minutes once a week for 4 sessions over 12 weeks. |
| Phase II arm II (watch videos) | Active comparator | Other: Media Intervention, Other: Survey AdministrationPatients passively watch videos for 30 minutes once a week for 4 sessions over 12 weeks. |
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Aged 8 to 13 years of age
- Have been diagnosed with cancer of any type in the prior 12 months
- Be English literate (we will amend this criterium when the study surveys are validated in Spanish). Parent/caregiver of child participant may be Spanish speaking
- Physically and cognitively able to participate in creative arts
- Expected to receive enough treatment at local site to participate in all four intervention sessions
Key exclusion criteria (2 listed)
- Not English literate
- Otherwise unable to complete study procedures
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 |
|---|---|---|
| Art TherapyParticipate in CrA | Procedure or surgery | Phase II arm I (CrA) |
| DiscussionAlso: Discuss, creating artParticipate in art focus group, art-making | Procedure or surgery | Phase I (focus group) |
| Media InterventionWatch videos | Other | Phase II arm II (watch videos) |
| Survey AdministrationAncillary studies | Other | Phase I (focus group), Phase II arm I (CrA), Phase II arm II (watch videos) |
Primary outcome
Number of participants that complete all interventions and data collection time points
Time frame: Up to day 90
Will be considered feasible if 80% of participants complete 4 intervention sessions and 3 data collection time points. Will be summarized across and within each study arm using means and standard deviations for continuous variables, and frequency counts and percentages for nominal variables.
6 secondary outcomes
Number of eligible participants that enroll in the study (feasibility threshold of 80%)
Time frame: Up to to 24 months
Number of participants that complete all interventions and all surveys in the study.
Time frame: Up to 24 months
Number of intervenor fidelity surveys that obtain at least 95% score.
Time frame: Up to 24 months
Comparison of scores on the PRO-CTCAE between intervention arms
Time frame: Up to 24 months
Comparison of scores on the PROMIS between intervention arms
Time frame: Up to 24 months
Comparison of scores on the Faces between intervention arms
Time frame: Up to 24 months
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 25 Aug 2026.
- Individual participant dataSharing planned: Yes. Will share by publishing in an ICMJE journal and will also submit data and metadata to the Dyad data repository.
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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.
Jennifer L Raybin, PhD RN principal investigator
OHSU Knight Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Art Therapy, Discussion and Media Intervention in people with Hematopoietic and Lymphatic System Neoplasm and Malignant Solid Neoplasm, run by OHSU Knight Cancer Institute 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 2 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: looking for participants now, as of the sponsor's last update on 25 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?
Contact Mia Nolting, BFA (415-518-4686, noltingm@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants that complete all interventions and data collection time points (time frame: Up to day 90). 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 25 Aug 2026.