Physical Activity Post-Cancer for Adolescents and Young Adults

NCT04947709 | Completed

• 1 other identifier: STUDY00018148
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Childhood Cancer Survivors

Outcome Measures

Primary Outcomes (2)

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

  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

  Baseline

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

  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

  Baseline to week 12

Secondary Outcomes (26)

• Patient reported outcomes-physical function mobility

  Baseline

• Patient reported outcomes-physical function mobility

  week 12

• Patient reported outcomes-anxiety

  Baseline

• Patient reported outcomes-anxiety

  Week 12

• Patient reported outcomes-depressive symptoms

  baseline

Other Outcomes (15)

• Costs

  Baseline to week 12

• Demographics

  baseline

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

  Baseline

Study Arms (2)

Physical activity intervention group

EXPERIMENTAL

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.

Behavioral: Physical Activity

Delayed-intervention control group

OTHER

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.

Behavioral: Physical Activity

Interventions

Physical Activity BEHAVIORAL

The main structure of the physical activity program will focus on increasing physical activity. Physical activity will initially start at a duration of 15-30 minute bouts, and at rate of perceived exertion levels of 5-6 (somewhat hard). Over the course of the intervention, goals will be set to progress to 60 minutes of continuous physical activity, at a rate of perceived exertion level of 5-6 (somewhat hard). Participants will be instructed on the use of the ratings of the perceived exertion scale (Borg's RPE 1-10 scale). Participants will be instructed to walk, or engage in other forms of leisure-time physical activity to achieve these goals (cycling, running, swimming, etc). As the adolescent and young adults' health and fitness status improve, frequency, intensity, and session duration will be modified accordingly during weekly support calls. Moreover, goals will be responsive to the most recent week's achieved minutes and rate of perceived exertion.

Delayed-intervention control group; Physical activity intervention group

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• males and females diagnosed with cancer;
• treated at Penn State Health Children's Hospital or Penn State Cancer Institute, Milton S. Hershey Medical Center;
• at least 1 year and up to 5 years post-cancer treatment;
• being aged between 10 to 17 years old at enrollment;
• being able to speak, read and understand the English language;
• 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;
• Parent fluency in written and spoken English;
• 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.

You may not qualify if:

• Received follow-up at a location other than Penn State Health Children's Hospital or Penn State Cancer Institute, Milton S. Hershey Medical Center;
• Evidence in the medical record of an absolute contraindication for physical activity;
• History of refractory or recurrent diseases
• Already meeting physical activity guidelines.

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead
• Four Diamonds Research Fund at Penn State Health Childrens Hospital: collaborator

Study Sites (1)

Penn State Health Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (1)

• Caru M, Dandekar S, Gordon B, Conroy DE, Barb ED, Doerksen SE, Smink GM, McKeone DJ, Shah NB, Greiner RJ, Schramm JW, Rao P, McGregor L, Schmitz KH. Implementing a behavioral physical activity program in children and adolescent survivors of childhood cancer: a pilot randomized controlled trial. J Behav Med. 2024 Oct;47(5):792-803. doi: 10.1007/s10865-024-00497-z. Epub 2024 May 12.

  PMID: 38735024 DERIVED

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Smita Dandekar, MD

  Milton S. Hershey Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomized controlled trial, utilizing a delayed-intervention control group.

Study Record Dates

• First Submitted: June 9, 2021
• First Posted: July 1, 2021
• Study Start: June 21, 2022
• Primary Completion: February 27, 2023
• Study Completion: August 1, 2023
• Last Updated: August 14, 2023

Record last verified: 2023-08

Locations

US (1)