Physical Activity Post-Cancer for Adolescents and Young Adults

Childhood Cancer Survivors Clinical Trial

— PAPAYA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04947709
• Other study ID #: STUDY00018148
• Status: Completed
• Phase: N/A
• Start date: June 21, 2022
• Est. completion date: August 1, 2023

Study information

• Verified date: August 2023
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 1, 2023
• Est. primary completion date: February 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Childhood Cancer Survivors

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Penn State Health Milton S. Hershey Medical Center	Hershey	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center	Four Diamonds Research Fund at Penn State Health Childrens Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Costs	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	Baseline to week 12
Other	Demographics	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.	baseline
Other	Physical activity-Godin-Shephard Leisure-Time Physical Activity Questionnaire (process outcome)	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	Baseline
Other	Physical activity-Godin-Shephard Leisure-Time Physical Activity Questionnaire (process outcome)	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	week 1
Other	Physical activity-Godin-Shephard Leisure-Time Physical Activity Questionnaire (process outcome)	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	week 2
Other	Physical activity-Godin-Shephard Leisure-Time Physical Activity Questionnaire (process outcome)	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	week 3
Other	Physical activity-Godin-Shephard Leisure-Time Physical Activity Questionnaire (process outcome)	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	week 4
Other	Physical activity-Godin-Shephard Leisure-Time Physical Activity Questionnaire (process outcome)	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	week 5
Other	Physical activity-Godin-Shephard Leisure-Time Physical Activity Questionnaire (process outcome)	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	week 6
Other	Physical activity-Godin-Shephard Leisure-Time Physical Activity Questionnaire (process outcome)	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	week 7
Other	Physical activity-Godin-Shephard Leisure-Time Physical Activity Questionnaire (process outcome)	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	week 8
Other	Physical activity-Godin-Shephard Leisure-Time Physical Activity Questionnaire (process outcome)	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	week 9
Other	Physical activity-Godin-Shephard Leisure-Time Physical Activity Questionnaire (process outcome)	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	week 10
Other	Physical activity-Godin-Shephard Leisure-Time Physical Activity Questionnaire (process outcome)	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	week 11
Other	Physical activity-Godin-Shephard Leisure-Time Physical Activity Questionnaire (process outcome)	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	week 12
Primary	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
Primary	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	Patient reported outcomes-physical function mobility	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	Baseline
Secondary	Patient reported outcomes-physical function mobility	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	week 12
Secondary	Patient reported outcomes-anxiety	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	Baseline
Secondary	Patient reported outcomes-anxiety	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	Week 12
Secondary	Patient reported outcomes-depressive symptoms	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	baseline
Secondary	Patient reported outcomes-depressive symptoms	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	Week 12
Secondary	Patient reported outcomes-fatigue	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	baseline
Secondary	Patient reported outcomes-fatigue	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	week 12
Secondary	Patient reported outcomes-peer relationships	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	baseline
Secondary	Patient reported outcomes-peer relationships	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	week 12
Secondary	Patient reported outcomes-social isolation	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	baseline
Secondary	Patient reported outcomes-social isolation	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	week 12
Secondary	Patient reported outcomes-pain interference	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	baseline
Secondary	Patient reported outcomes-pain interference	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	week 12
Secondary	Patient reported outcomes-pain intensity	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	baseline
Secondary	Patient reported outcomes-pain intensity	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	week 12
Secondary	Patient reported outcomes-sleep disturbance	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	baseline
Secondary	Patient reported outcomes-sleep disturbance	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	week 12
Secondary	Patient reported outcomes-cognitive function	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	baseline
Secondary	Patient reported outcomes-cognitive function	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	week 12
Secondary	physical function-six minute walking test	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	baseline
Secondary	physical function-six minute walking test	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	week 12
Secondary	physical function-30 second chair stand	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	baseline
Secondary	physical function-30 second chair stand	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	week 12
Secondary	physical function-timed up and go	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	baseline
Secondary	physical function-timed up and go	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	week 12