Health TrialsbyHealthPanel

CREATE: Art for Children With Cancer

ConditionsHematopoietic and Lymphatic System NeoplasmMalignant Solid Neoplasm
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-13
SponsorOHSU Knight Cancer Institute

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Not English literate

Otherwise unable to complete study procedures

Trial design

Design model

Sequential

Treatments tested in this trial

  • Art Therapy

    Procedure/Surgery

    Participate in CrA

  • Discussion

    Procedure/Surgery

    Participate in art focus group, art-making

  • Media Intervention

    Other intervention

    Watch videos

  • Survey Administration

    Other intervention

    Ancillary studies

Treatment groups

72 Participants
are divided into 3 treatment groups
Group A: Phase I (focus group)Active comparator 2 interventions
Group B: Phase II arm I (CrA)Experimental treatment 2 interventions
Group C: Phase II arm II (watch videos)Active comparator 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Up to day 90

Secondary outcomes

1

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.

Time frame
Up to to 24 months
2

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.

Time frame
Up to 24 months
3

Number of intervenor fidelity surveys that obtain at least 95% score.

Will use 95% confidence intervals to estimate the precision of all point estimates.

Time frame
Up to 24 months
4

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.

Time frame
Up to 24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

OHSU Knight Cancer Institute

Lead sponsor

Oregon Health and Science University

Collaborator

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Source ClinicalTrials.gov
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