Exercise Intervention Coupled With Standard Post-cancer Directed Treatment Care to Reduce Chronic Pain in Childhood Cancer Survivors Who Have Completed Cancer-directed Therapy Less Than One Year
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Acceptability of the intervention
研究概览
简要总结
The purpose of this study is to demonstrate that integration of exercise intervention into standard post-cancer directed treatment care will improve patient reported pain, decrease the need for medications to manage chronic pain and improve functional and psychosocial outcomes in survivors of cancers in children and adolescents. Our central hypothesis is that integration of exercise interventions into standard post-cancer directed treatment care will be acceptable and feasible while improving patients' pain, decreasing the cumulative dose of pain medication and improving patients' functional and psychosocial outcomes as compared to patients who only receive standard post-cancer directed treatment care.
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
- •Male and female CCS diagnosed with any type of cancer
- •CCS who have completed all standard/planned cancer treatment and are stable at the time of recruitment
- •CCS are < 1-year post cancer therapy
- •CCS who have chronic pain (pain will be self-reported by the participant, will have to be ≥1 on a scale of 10 and lasting for 3 months or longer)
- •CCS who are age between 10 and 17 years old at the time of enrollment
- •CCS who are and who are not non-ambulatory/wheelchair bound.
- •CCS and parent/legal guardian must be able to speak, read and understand the English language
- •CCS's parent or legal guardian must be able to provide and understand informed consent
- •CCS must be able to provide and understand assent
- •CCS must be able to attend three visits (baseline, 8 and 16-week follow-up) at the Penn State Health Children's Hospital
- •CCS and parent/legal guardian must have access to a computer, smartphone or tablet
- •Note: The agreement of the attending oncologist will be required for the participation of CCS eligible for this study.
排除标准
- •CCS who have not completed all standard/planned cancer treatment and/or not in complete remission at the time of recruitment
- •CCS who are > 1-year post cancer therapy
- •CCS who are < 10 years old and > 17 years old at the time of enrollment
- •CCS who have evidence in their medical record of an absolute contraindication to complete any of the physical assessments in their medical record. This exclusion criterion is at the oncologist's discretion when research staff will contact the medical oncologist via secure email or secure message through the electronic medical record for approval to approach their patients for the study and for medical clearance. The oncologists can update this information at any time during the study if there is evidence of an absolute contraindication to complete any of the physical assessments.
- •CCS who have history of refractory or recurrent cancer
- •CCS or their parent/legal guardian who are unable to speak, read, and understand the English language
- •CCS who are unable to access and complete online questionnaires
研究组 & 干预措施
Physical activity intervention coupled with standard post-cancer directed treatment care group
干预措施: Physical activity intervention coupled with standard post-cancer directed treatment care (Behavioral)
Standard post-cancer directed treatment care control group
干预措施: Standard post-cancer directed treatment care control (Other)
结局指标
主要结局
Acceptability of the intervention
时间窗: Baseline
The number of participants approached who agree to participate in the study
Feasibility of the intervention
时间窗: Baseline to week 16
The number of participants randomized to the physical activity program intervention coupled with standard post-cancer directed treatment care who complete at least 50% of the physical activity intervention.
次要结局
- Measure changes in patient reported outcomes(Baseline, week 8 and week 16)
- Measure changes in cumulative dose of pain medications(Baseline, week 4, week 8, week 12 and week 16)
- Measure changes in patient functional outcomes (6-min walking test)(Baseline and week 16)
- Measure changes in patient functional outcomes (grip strength test)(Baseline and week 16)
- Measure changes in patient functional outcomes ("Timed Up and Go" test)(Baseline and week 16)
- Measure changes in chronic pain levels(Baseline, week 8 and week 16)
- Measure changes in patient functional outcomes (30-second chair stand test)(Baseline and week 16)
- Measure changes in physical activity level(Baseline, week 8 and week 16)
研究者
Smita Dandekar
Dr. Smita Dandekar, MD
Penn State Health Milton S Hershey Medical Center