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Completed

NCT Number: NCT04947709

Physical Activity Post-Cancer for Adolescents and Young Adults

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.

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Key information

Conditions

Childhood Cancer Survivors

Age range

10 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Penn State Health Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adolescent and young adult inclusion criteria will be as follows:

  • 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.

Exclusion criteria

Adolescent and young adult exclusion criteria will be as follows:

  • 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;
  • 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;
  • History of refractory or recurrent diseases
  • Already meeting physical activity guidelines.

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 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

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

    Time frame: 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 outcomes

  1. Patient reported outcomes-physical function mobility

    Time frame: Baseline

    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

  2. Patient reported outcomes-physical function mobility

    Time frame: 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

  3. Patient reported outcomes-anxiety

    Time frame: Baseline

    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

  4. Patient reported outcomes-anxiety

    Time frame: 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

  5. Patient reported outcomes-depressive symptoms

    Time frame: baseline

    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

  6. Patient reported outcomes-depressive symptoms

    Time frame: 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

  7. Patient reported outcomes-fatigue

    Time frame: baseline

    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

  8. Patient reported outcomes-fatigue

    Time frame: 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

  9. Patient reported outcomes-peer relationships

    Time frame: baseline

    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

  10. Patient reported outcomes-peer relationships

    Time frame: 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

  11. Patient reported outcomes-social isolation

    Time frame: baseline

    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

  12. Patient reported outcomes-social isolation

    Time frame: 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

  13. Patient reported outcomes-pain interference

    Time frame: baseline

    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

  14. Patient reported outcomes-pain interference

    Time frame: 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

  15. Patient reported outcomes-pain intensity

    Time frame: baseline

    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

  16. Patient reported outcomes-pain intensity

    Time frame: 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

  17. Patient reported outcomes-sleep disturbance

    Time frame: baseline

    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

  18. Patient reported outcomes-sleep disturbance

    Time frame: 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

  19. Patient reported outcomes-cognitive function

    Time frame: baseline

    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

  20. Patient reported outcomes-cognitive function

    Time frame: 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

  21. physical function-six minute walking test

    Time frame: baseline

    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

  22. physical function-six minute walking test

    Time frame: 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

  23. physical function-30 second chair stand

    Time frame: baseline

    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

  24. physical function-30 second chair stand

    Time frame: 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

  25. physical function-timed up and go

    Time frame: baseline

    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

  26. physical function-timed up and go

    Time frame: 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

Other outcomes

  1. Costs

    Time frame: Baseline to week 12

    Cost of carrying out the intervention will be also a secondary endpoint. We will include staff time, space, and equipment in our estimation of cost per patient to carry out the intervention

  2. Demographics

    Time frame: baseline

    At baseline, assented/consented adolescents and young adults will be asked to complete the demographic questionnaires about age (years), sex (male or female), ethnicity (white or black or Asian or Hispanic other/mixed), education level. Adolescents and young adult participants will also be asked age at diagnosis (years), time since diagnosis (months) and diagnosis. Also, treatment interventions including cranial radiation (yes or no) and chemotherapy (yes or no) will be obtained. Adolescents and young adults will be asked if they are currently receiving any mental health-related treatment and/or intervention.

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

    Time frame: Baseline

    Physical activity will be assessed by a self-reported, 4-item questionnaire. This questionnaire will be administered over the telephone or HIPAA compliant ZOOM weekly. Weekly frequencies of strenuous, moderate, and light activities are reported, and using a standardized formula, total weekly leisure activity is calculated.

    • Less than 14 units: Insufficiently active
    • 14 to 23 units: Moderately active
    • 24 units or more: Active

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

    Time frame: week 1

    Physical activity will be assessed by a self-reported, 4-item questionnaire. This questionnaire will be administered over the telephone or HIPAA compliant ZOOM weekly. Weekly frequencies of strenuous, moderate, and light activities are reported, and using a standardized formula, total weekly leisure activity is calculated.

    • Less than 14 units: Insufficiently active
    • 14 to 23 units: Moderately active
    • 24 units or more: Active

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

    Time frame: week 2

    Physical activity will be assessed by a self-reported, 4-item questionnaire. This questionnaire will be administered over the telephone or HIPAA compliant ZOOM weekly. Weekly frequencies of strenuous, moderate, and light activities are reported, and using a standardized formula, total weekly leisure activity is calculated.

    • Less than 14 units: Insufficiently active
    • 14 to 23 units: Moderately active
    • 24 units or more: Active

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

    Time frame: week 3

    Physical activity will be assessed by a self-reported, 4-item questionnaire. This questionnaire will be administered over the telephone or HIPAA compliant ZOOM weekly. Weekly frequencies of strenuous, moderate, and light activities are reported, and using a standardized formula, total weekly leisure activity is calculated.

    • Less than 14 units: Insufficiently active
    • 14 to 23 units: Moderately active
    • 24 units or more: Active

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

    Time frame: week 4

    Physical activity will be assessed by a self-reported, 4-item questionnaire. This questionnaire will be administered over the telephone or HIPAA compliant ZOOM weekly. Weekly frequencies of strenuous, moderate, and light activities are reported, and using a standardized formula, total weekly leisure activity is calculated.

    • Less than 14 units: Insufficiently active
    • 14 to 23 units: Moderately active
    • 24 units or more: Active

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

    Time frame: week 5

    Physical activity will be assessed by a self-reported, 4-item questionnaire. This questionnaire will be administered over the telephone or HIPAA compliant ZOOM weekly. Weekly frequencies of strenuous, moderate, and light activities are reported, and using a standardized formula, total weekly leisure activity is calculated.

    • Less than 14 units: Insufficiently active
    • 14 to 23 units: Moderately active
    • 24 units or more: Active

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

    Time frame: week 6

    Physical activity will be assessed by a self-reported, 4-item questionnaire. This questionnaire will be administered over the telephone or HIPAA compliant ZOOM weekly. Weekly frequencies of strenuous, moderate, and light activities are reported, and using a standardized formula, total weekly leisure activity is calculated.

    • Less than 14 units: Insufficiently active
    • 14 to 23 units: Moderately active
    • 24 units or more: Active

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

    Time frame: week 7

    Physical activity will be assessed by a self-reported, 4-item questionnaire. This questionnaire will be administered over the telephone or HIPAA compliant ZOOM weekly. Weekly frequencies of strenuous, moderate, and light activities are reported, and using a standardized formula, total weekly leisure activity is calculated.

    • Less than 14 units: Insufficiently active
    • 14 to 23 units: Moderately active
    • 24 units or more: Active

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

    Time frame: week 8

    Physical activity will be assessed by a self-reported, 4-item questionnaire. This questionnaire will be administered over the telephone or HIPAA compliant ZOOM weekly. Weekly frequencies of strenuous, moderate, and light activities are reported, and using a standardized formula, total weekly leisure activity is calculated.

    • Less than 14 units: Insufficiently active
    • 14 to 23 units: Moderately active
    • 24 units or more: Active

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

    Time frame: week 9

    Physical activity will be assessed by a self-reported, 4-item questionnaire. This questionnaire will be administered over the telephone or HIPAA compliant ZOOM weekly. Weekly frequencies of strenuous, moderate, and light activities are reported, and using a standardized formula, total weekly leisure activity is calculated.

    • Less than 14 units: Insufficiently active
    • 14 to 23 units: Moderately active
    • 24 units or more: Active

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

    Time frame: week 10

    Physical activity will be assessed by a self-reported, 4-item questionnaire. This questionnaire will be administered over the telephone or HIPAA compliant ZOOM weekly. Weekly frequencies of strenuous, moderate, and light activities are reported, and using a standardized formula, total weekly leisure activity is calculated.

    • Less than 14 units: Insufficiently active
    • 14 to 23 units: Moderately active
    • 24 units or more: Active

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

    Time frame: week 11

    Physical activity will be assessed by a self-reported, 4-item questionnaire. This questionnaire will be administered over the telephone or HIPAA compliant ZOOM weekly. Weekly frequencies of strenuous, moderate, and light activities are reported, and using a standardized formula, total weekly leisure activity is calculated.

    • Less than 14 units: Insufficiently active
    • 14 to 23 units: Moderately active
    • 24 units or more: Active

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

    Time frame: week 12

    Physical activity will be assessed by a self-reported, 4-item questionnaire. This questionnaire will be administered over the telephone or HIPAA compliant ZOOM weekly. Weekly frequencies of strenuous, moderate, and light activities are reported, and using a standardized formula, total weekly leisure activity is calculated.

    • Less than 14 units: Insufficiently active
    • 14 to 23 units: Moderately active
    • 24 units or more: Active

Sponsors and collaborators

Lead sponsor

Milton S. Hershey Medical Center

Other

Collaborators

  • Four Diamonds Research Fund at Penn State Health Childrens Hospital

Registry information

Official study title

Physical Activity Post-Cancer for Adolescents and Young Adults (PAPAYA)

Acronym: PAPAYA

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 1, 2021
Registry last updated
Aug 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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