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patient education document for Acute Lymphoblastic Leukemia (PLAY II Trial)

N/A
Waitlist Available
Led By Andrea Stracciolini, MD
Research Sponsored by Boston Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
• Children 6-11 years presenting for an annual well-child appointment at Longwood Pediatrics
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 2-4
Awards & highlights

PLAY II Trial Summary

This trial will investigate the feasibility of screening for physical literacy in primary care settings, as well as the efficacy of an intervention designed to improve physical literacy.

Eligible Conditions
  • Acute Lymphoblastic Leukemia
  • Gastroparesis

PLAY II Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

PLAY II Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 2-4
This trial's timeline: 3 weeks for screening, Varies for treatment, and month 2-4 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Physical Literacy Vital Sign (PAVSped) total score.
Secondary outcome measures
Improvement on the follow-up the Physical Literacy Vital Sign (PAVSped) survey total score.

PLAY II Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: patient educationExperimental Treatment1 Intervention
The intervention group will receive the patient education document with their questionnaire, randomization will occur by the study team prior to subject visits. The patient education will be designed to address and investigate the four domains of physical literacy including, knowledge and understanding, motivation and confidence, daily behavior, and physical competence, (i.e., referral based training/PT (passive), self-motivated/directed exercise choice (speaks to child ownership/motivation), simple play outside 60 minutes/day (middle)).
Group II: standard of careActive Control1 Intervention

Find a Location

Who is running the clinical trial?

Boston Children's HospitalLead Sponsor
761 Previous Clinical Trials
5,579,530 Total Patients Enrolled
Andrea Stracciolini, MDPrincipal InvestigatorBoston Children's Hospital

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there availability for participants to join this research?

"Clinicaltrials.gov indicates that this trial is now recruiting, having been posted on August 1st 2021 and most recently revised on February 7th 2022."

Answered by AI

Is the age limit for enrollment in this trial set at eighty years or younger?

"This trial is only enrolling patients aged 6 to 11; however, there are 27 studies for minors and 6 that can be accessed by seniors."

Answered by AI

Who is eligible to enrol in this clinical research?

"This study is seeking 200 minors between the ages of 6 and 11. To be eligible, children must meet specific criteria outlined by Longwood Pediatrics such as attending an annual well-child appointment."

Answered by AI

To what extent is enrollment progressing in this medical experiment?

"Affirmative. Clinicaltrials.gov highlights that this clinical trial is actively recruiting patients, having first been posted on August 1st 2021 and last modified on February 7th 2022. 200 research subjects need to be sourced from a single centre for the study to reach its completion."

Answered by AI
~55 spots leftby Apr 2025