Baseline Anxiety Trajectories in Pediatric Radiation Therapy Observational Cohort

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2-12
SponsorM.D. Anderson Cancer Center

About this trial

This is a prospective, observational cohort study of pediatric patients ages 2-12 undergoing radiation therapy at MD Anderson Cancer Center.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Provision of signed and dated informed consent from a parent or legal guardian.

For children age 7 and older, provision of informed assent in addition to parental consent, consistent with institutional guidelines.

Stated willingness of parent/guardian and child (as appropriate) to comply with study procedures (i.e., observation during scheduled radiation therapy appointments).

Male or female, ages 2-12 years.

Disqualifiers

Has already completed the simulation session for radiation therapy prior to enrollment.

Declines parental consent or, when applicable, child assent.

Trial population

UT MD Anderson patients

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Safety and Adverse Events (AEs)

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Time frame
Through study completion; an average of 1 year.

Secondary outcomes

Other outcomes

Sponsors and contacts

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