Physical Activity Post-Cancer for Adolescents and Young Adults (PAPAYA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Acceptability-the proportion of adolescents and young adults who agree to participate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Acceptability-the proportion of adolescents and young adults who agree to participate
时间窗: 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
Feasibility-the proportion of adolescents and young adults who complete at least 50% of the physical activity intervention
时间窗: 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
次要结局
- physical function-timed up and go(week 12)
- Patient reported outcomes-physical function mobility(week 12)
- Patient reported outcomes-anxiety(Week 12)
- Patient reported outcomes-peer relationships(week 12)
- Patient reported outcomes-social isolation(week 12)
- Patient reported outcomes-depressive symptoms(Week 12)
- Patient reported outcomes-fatigue(week 12)
- Patient reported outcomes-pain interference(week 12)
- physical function-six minute walking test(week 12)
- Patient reported outcomes-pain intensity(week 12)
- Patient reported outcomes-sleep disturbance(week 12)
- Patient reported outcomes-cognitive function(week 12)
- physical function-30 second chair stand(week 12)
研究者
Smita Dandekar
Associate Professor
Milton S. Hershey Medical Center