Physical Activity Post-Cancer for Adolescents and Young Adults

Not Applicable

Completed

• Conditions: Childhood Cancer Survivors
• Interventions: Behavioral: Physical Activity

• Registration Number: NCT04947709
• Lead Sponsor: Milton S. Hershey Medical Center

Brief Summary

The Physical Activity Post-Cancer for Adolescents and Young Adults (PAPAYA) trial aims to carry out a pilot randomized controlled trial among 10-17 year-old adolescents and young adults, at least 1 year and up to 5 years post-cancer treatment. The trial will evaluate the effects of a 12 week physical activity intervention to improve patient reported outcomes and physical function, in comparison to a delayed-intervention control group.

Detailed Description

The investigators will recruit 40 adolescents and young adults at least 1 year, and up to 5 years post-cancer treatment, and randomize them (20 randomized to each condition) to either a 12-week physical activity intervention to improve patient-reported outcomes and physical function, or delayed-intervention control group.

Participants randomized to the intervention group: 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. The physical activity intervention will be individualized by research staff according to the adolescents and young adults' health status, results from the physical fitness assessment, and most recent week's achieved minutes. The physical activity intervention will be modified during weekly support calls with a study team member, including frequency, intensity, time, and type, to maximize adherence and compliance

Participants randomized to the delayed-intervention control group: They will not receive the physical activity intervention, and they will not receive weekly support calls. Physical activity advice according to the Children's Oncology Group Guidelines for Diet and Physical Activity recommendations will be offered to participants randomized to the delayed-intervention control group following completion of 12-week follow-up.

Study Timeline

• Study First Submitted: 2021-06-09
• Study First Submitted QC: 2021-06-23
• Study First Posted: 2021-07-01
• Study Start: 2022-06-21
• Primary Completion: 2023-02-27
• Status Verified: 2023-08
• Study Completion: 2023-08-01
• Last Update Submitted: 2023-08-09
• Last Update Posted: 2023-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Adolescent and young adult inclusion criteria will be as follows:

1. males and females diagnosed with cancer;
2. treated at Penn State Health Children's Hospital or Penn State Cancer Institute, Milton S. Hershey Medical Center;
3. at least 1 year and up to 5 years post-cancer treatment;
4. being aged between 10 to 17 years old at enrollment;
5. being able to speak, read and understand the English language;
6. adolescents and young adults have to be able to assent, and parents/guardians have to be able to consent to the study in an informed manner;
7. Parent fluency in written and spoken English;
8. Adolescents and young adults or their parents must have access to a phone or Zoom

Note: The agreement of the attending oncologist will be required for the participation of adolescents and young adults eligible for this study.

Exclusion Criteria

Adolescent and young adult exclusion criteria will be as follows:

1. Received follow-up at a location other than Penn State Health Children's Hospital or Penn State Cancer Institute, Milton S. Hershey Medical Center;
2. Evidence in the medical record of an absolute contraindication for physical activity;
3. cardiac exclusion criteria: Class II, III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system, history of acute coronary syndromes, uncertain or uncontrolled arrhythmia, uncontrolled hypertension, syncope, acute myocarditis, pericarditis, or endocarditis, acute pulmonary embolus or pulmonary infarction, thrombosis of lower extremities, suspected dissecting aneurysm, pulmonary edema, respiratory failure, acute non-cardiopulmonary disorder that may affect exercise performance or be aggravated by exercise, mental impairment leading to inability to cooperate;
4. History of refractory or recurrent diseases
5. Already meeting physical activity guidelines.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Delayed-intervention control group	Physical Activity	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.
Physical activity intervention group	Physical Activity	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.

Primary Outcome Measures

Name	Time	Method
Acceptability-the proportion of adolescents and young adults who agree to participate	Baseline	The proportion of adolescents and young adults who agree to participate among those deemed eligible by the attending oncologist; Range 0-100%-Higher scores indicate greater acceptability
Feasibility-the proportion of adolescents and young adults who complete at least 50% of the physical activity intervention	Baseline to week 12	The percentage of those randomized to the physical activity intervention that complete at least 50% of the physical activity intervention. Participants will be instructed by a project manager during weekly support calls to accumulate a specific amount of physical activity each week. Participants who self-report completing at least 50% of the physical activity, determined by the Godin-Shephard Leisure-Time Physical Activity Questionnaire, will be deemed compliant.; Range 0-100%-Higher scores indicate greater feasibility

Secondary Outcome Measures

Name	Time	Method
physical function-timed up and go	week 12	The timed up and go test will be administered to assess physical function. Participants will aim to stand up, walk 3 meters, turn around, and walk back to the chair as fast as possible.; Shorter durations indicate greater physical function
Patient reported outcomes-physical function mobility	week 12	the physical function mobility assessment domain from the PROMIS (Patient-Reported Outcomes Measurement Information System Pediatric Profile v2.0-Profile-49); Range 8-40, higher scores indicate greater physical function mobility
Patient reported outcomes-anxiety	Week 12	the anxiety assessment domain from the PROMIS (Patient-Reported Outcomes Measurement Information System Pediatric Profile v2.0-Profile-49); Range 8-40, higher scores indicate greater anxiety
Patient reported outcomes-peer relationships	week 12	the peer relationships assessment domain from the PROMIS (Patient-Reported Outcomes Measurement Information System Pediatric Profile v2.0-Profile-49); Range 8-40, higher scores indicate greater peer relationships
Patient reported outcomes-social isolation	week 12	the social isolation assessment domain from the PROMIS (Patient-Reported Outcomes Measurement Information System Pediatric Profile v2.0-Profile-49); Range 8-40, higher scores indicate greater social isolation
Patient reported outcomes-depressive symptoms	Week 12	the depressive symptoms assessment domain from the PROMIS (Patient-Reported Outcomes Measurement Information System Pediatric Profile v2.0-Profile-49); Range 8-40, higher scores indicate greater depressive symptoms
Patient reported outcomes-fatigue	week 12	the fatigue assessment domain from the PROMIS (Patient-Reported Outcomes Measurement Information System Pediatric Profile v2.0-Profile-49); Range 8-40, higher scores indicate greater fatigue
Patient reported outcomes-pain interference	week 12	the pain interference assessment domain from the PROMIS (Patient-Reported Outcomes Measurement Information System Pediatric Profile v2.0-Profile-49); Range 8-40, higher scores indicate greater pain interference
physical function-six minute walking test	week 12	The six minute walking test will be administered to assess physical function. Participants will aim to walk as far as possible for 6 minutes.; Further distances indicate greater physical function
Patient reported outcomes-pain intensity	week 12	the pain intensity assessment domain from the PROMIS (Patient-Reported Outcomes Measurement Information System Pediatric Profile v2.0-Profile-49); Range 0-10, higher scores indicate greater pain intensity
Patient reported outcomes-sleep disturbance	week 12	the sleep disturbance assessment domain from the PROMIS (Patient-Reported Outcomes Measurement Information System Pediatric Profile v2.0-Profile-49); Range 8-40, higher scores indicate greater sleep disturbance
Patient reported outcomes-cognitive function	week 12	the cognitive function assessment domain from the PROMIS (Patient-Reported Outcomes Measurement Information System Pediatric Profile v2.0-Profile-49); Range 7-35, higher scores indicate greater cognitive function
physical function-30 second chair stand	week 12	The 30 second chair stand test will be administered to assess physical function. Participants will aim to sit and rise out of a chair as many times as possible in 30 seconds.; Greater amounts of sit/stands indicate greater physical function

Trial Locations

Locations (1)

Penn State Health Milton S. Hershey Medical Center; 🇺🇸 Hershey, Pennsylvania, United States