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Physical Activity for Childhood Cancer Survivors (PAPAYA Trial)

N/A

Waitlist Available

Led By Kathryn Schmitz, PhD

Research Sponsored by Milton S. Hershey Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline

Awards & highlights

PAPAYA Trial Summary

This trial will test the effects of a 12-week physical activity intervention on 10-17 year-olds who have had cancer, to see if it improves patient reported outcomes and physical function.

PAPAYA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Acceptability-the proportion of adolescents and young adults who agree to participate

Feasibility-the proportion of adolescents and young adults who complete at least 50% of the physical activity intervention

Secondary outcome measures

Patient reported outcomes-anxiety

Patient reported outcomes-cognitive function

Patient reported outcomes-depressive symptoms

+10 more

Other outcome measures

Costs

Demographics

Physical activity-Godin-Shephard Leisure-Time Physical Activity Questionnaire (process outcome)

PAPAYA Trial Design

2Treatment groups

Experimental Treatment

Group I: Physical activity intervention groupExperimental Treatment1 Intervention

The physical activity intervention will be structured to increase moderate-to-vigorous intensity aerobic physical activity, to achieve the 60-minute goal, five days per week. The intervention will also include weekly support calls from research staff to improve compliance to physical activity intervention.

Group II: Delayed-intervention control groupExperimental Treatment1 Intervention

Participants randomized to the delayed-intervention control group will serve as the control group for 12 weeks, and will not receive physical activity intervention during this time and will not receive weekly support calls. After completion of the control group, participants will be offered physical activity advice according to the Children's Oncology Group Guidelines for Diet and Physical Activity recommendations. This delayed-intervention control group design is used not only to boost recruitment, but to eventually confer the benefits of physical activity to all those who enter the trial.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Physical Activity

2019

Completed Phase 3

~4710

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Find a Location

Who is running the clinical trial?

Milton S. Hershey Medical CenterLead Sponsor

492 Previous Clinical Trials

2,798,782 Total Patients Enrolled

1 Trials studying Childhood Cancer Survivors

20 Patients Enrolled for Childhood Cancer Survivors

Four Diamonds Research Fund at Penn State Health Childrens HospitalUNKNOWN

1 Previous Clinical Trials

20 Total Patients Enrolled

1 Trials studying Childhood Cancer Survivors

20 Patients Enrolled for Childhood Cancer Survivors

Kathryn Schmitz, PhDPrincipal InvestigatorMilton S. Hershey Medical Center

10 Previous Clinical Trials

1,676 Total Patients Enrolled

Frequently Asked Questions

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

Does the trial accept participants under fifty years of age?

"According to the parameters of this trial, minors between 10 and 17 years old are eligible for enrollment."

Answered by AI

Who meets the criteria to partake in this clinical trial?

"Applicants to this trial must have been diagnosed with childhood cancer and fall between the ages of 10-17. A total of 40 participants are needed for completion of the study."

Answered by AI

How many individuals have been included in this research project?

"Affirmative. According to information on clinicaltrials.gov, this healthcare trial is actively recruiting participants. Initially posted in June of 2022 and most recently updated in October, the experiment seeks 40 patients from 2 locations."

Answered by AI

What are the intended outcomes of this research initiative?

"This study will use the Baseline timeframe to measure its primary outcome, which is the feasibility of recruiting adolescents and young adults who complete at least half of their physical activity intervention. Secondary measured outcomes include patient reported anxiety, sleep disturbance, and social isolation as assessed by PROMIS (Patient-Reported Outcomes Measurement Information System Pediatric Profile v2.0-Profile-49). Each metric has a range from 8 to 40; higher scores representing greater levels in each respective area."

Answered by AI

Is enrollment in this project still available for eligible participants?

"Indeed, the information available on clinicaltrials.gov confirms that this medical research is currently seeking volunteers. The trial was initially published on June 21st 2022 and latest updated October 5th of the same year. 40 participants are needed to be recruited from two distinct health facilities."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Physical Activity Post-Cancer for Adolescents and Young Adults

Smita Dandekar 2022. "Physical Activity Post-Cancer for Adolescents and Young Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04947709.