Physical Activity Post-Cancer for Adolescents and Young Adults

NCT ID: NCT04947709

Last Updated: 2023-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-21
• Study Completion Date: 2023-08-01

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.

Conditions

Childhood Cancer Survivors

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Physical activity 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 to improve compliance to physical activity intervention.

Group Type: EXPERIMENTAL

Physical Activity

Intervention Type: 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

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.

Group Type: OTHER

Physical Activity

Intervention Type: 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.

Interventions

Physical Activity

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

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;

4. History of refractory or recurrent diseases

5. Already meeting physical activity guidelines.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Four Diamonds Research Fund at Penn State Health Childrens Hospital

UNKNOWN

Sponsor Role: collaborator

Milton S. Hershey Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Smita Dandekar

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Smita Dandekar, MD

Role: PRINCIPAL_INVESTIGATOR

Milton S. Hershey Medical Center

Locations

Penn State Health Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 38735024 (View on PubMed)

Other Identifiers

STUDY00018148

Identifier Type: -

Identifier Source: org_study_id