Clinical trial NCT04947709: Physical Activity Post-Cancer for Adolescents and Young Adults
Official title: Physical Activity Post-Cancer for Adolescents and Young Adults (PAPAYA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Cancer Survivors
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
Collaborators: name: Four Diamonds Research Fund at Penn State Health Childrens Hospital
First posted: 2021-07-01
Enrollment: 40
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial, utilizing a delayed-intervention control group.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Acceptability-the proportion of adolescents and young adults who agree to participate
timeFrame: Baseline
measure: Feasibility-the proportion of adolescents and young adults who complete at least 50% of the physical activity intervention
timeFrame: Baseline to week 12
Secondary outcomes:
measure: Patient reported outcomes-physical function mobility
timeFrame: Baseline
measure: Patient reported outcomes-physical function mobility
timeFrame: week 12
measure: Patient reported outcomes-anxiety
timeFrame: Baseline
measure: Patient reported outcomes-anxiety
timeFrame: Week 12
measure: Patient reported outcomes-depressive symptoms
timeFrame: baseline
measure: Patient reported outcomes-depressive symptoms
timeFrame: Week 12
measure: Patient reported outcomes-fatigue
timeFrame: baseline
measure: Patient reported outcomes-fatigue
timeFrame: week 12
measure: Patient reported outcomes-peer relationships
timeFrame: baseline
measure: Patient reported outcomes-peer relationships
timeFrame: week 12
measure: Patient reported outcomes-social isolation
timeFrame: baseline
measure: Patient reported outcomes-social isolation
timeFrame: week 12
measure: Patient reported outcomes-pain interference
timeFrame: baseline
measure: Patient reported outcomes-pain interference
timeFrame: week 12
measure: Patient reported outcomes-pain intensity
timeFrame: baseline
measure: Patient reported outcomes-pain intensity
timeFrame: week 12
measure: Patient reported outcomes-sleep disturbance
timeFrame: baseline
measure: Patient reported outcomes-sleep disturbance
timeFrame: week 12
measure: Patient reported outcomes-cognitive function
timeFrame: baseline
measure: Patient reported outcomes-cognitive function
timeFrame: week 12
measure: physical function-six minute walking test
timeFrame: baseline
measure: physical function-six minute walking test
timeFrame: week 12
measure: physical function-30 second chair stand
timeFrame: baseline
measure: physical function-30 second chair stand
timeFrame: week 12
measure: physical function-timed up and go
timeFrame: baseline
measure: physical function-timed up and go
timeFrame: week 12
Other outcomes:
measure: Costs
timeFrame: Baseline to week 12
measure: Demographics
timeFrame: baseline
measure: Physical activity-Godin-Shephard Leisure-Time Physical Activity Questionnaire (process outcome)
timeFrame: Baseline
measure: Physical activity-Godin-Shephard Leisure-Time Physical Activity Questionnaire (process outcome)
timeFrame: week 1
measure: Physical activity-Godin-Shephard Leisure-Time Physical Activity Questionnaire (process outcome)
timeFrame: week 2
measure: Physical activity-Godin-Shephard Leisure-Time Physical Activity Questionnaire (process outcome)
timeFrame: week 3
measure: Physical activity-Godin-Shephard Leisure-Time Physical Activity Questionnaire (process outcome)
timeFrame: week 4
measure: Physical activity-Godin-Shephard Leisure-Time Physical Activity Questionnaire (process outcome)
timeFrame: week 5
measure: Physical activity-Godin-Shephard Leisure-Time Physical Activity Questionnaire (process outcome)
timeFrame: week 6
measure: Physical activity-Godin-Shephard Leisure-Time Physical Activity Questionnaire (process outcome)
timeFrame: week 7
measure: Physical activity-Godin-Shephard Leisure-Time Physical Activity Questionnaire (process outcome)
timeFrame: week 8
measure: Physical activity-Godin-Shephard Leisure-Time Physical Activity Questionnaire (process outcome)
timeFrame: week 9
measure: Physical activity-Godin-Shephard Leisure-Time Physical Activity Questionnaire (process outcome)
timeFrame: week 10
measure: Physical activity-Godin-Shephard Leisure-Time Physical Activity Questionnaire (process outcome)
timeFrame: week 11
measure: Physical activity-Godin-Shephard Leisure-Time Physical Activity Questionnaire (process outcome)
timeFrame: week 12
Locations:
city: Hershey
country: United States
facility: Penn State Health Milton S. Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Milton S. Hershey Medical Center
name: Smita Dandekar, MD
role: PRINCIPAL_INVESTIGATOR
References: