An Exploratory Study Evaluating the Feasibility of a Health Care Provider Guided Exercise Intervention Prior to Surgical Resection of Pancreatic Cancer With Biological Correlative Studies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Number of Intervention Arm Participants in Compliance with HCP Exercise Intervention
研究概览
简要总结
Pilot study evaluating the feasibility of a 2-4 week health care provider guided exercise intervention prior to surgery for pancreatic cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willingness and ability to participate in the study procedures
- •Pathologically confirmed pancreatic cancer
- •Candidate for neoadjuvant therapy followed by surgical resection with potentially curative intent. Note: There is no limitation on duration of neoadjuvant therapy.
- •Planned to have at least 2 weeks after completing the last neoadjuvant therapy and surgery
- •Over the age of 18
- •Ability to engage in physical activity as determined by physiatrist review after completion of the Physical Activity Readiness questionnaire (PAR-Q) exercise survey and chart review
- •Agree to study blood draws and tissue collection
排除标准
- •Evidence of metastatic disease
- •Inability to complete physical activity due to recent injury or surgery
- •Uncontrolled heart disease limiting physical activity
- •Participation in another interventional trial that excludes participation in this protocol
- •Subjects who anticipate undergoing a procedure during the course of the trial that will render them unable to engage in physical activity for more than 48 hours
- •Pregnant subjects
- •Individuals who lack the capacity to consent
研究组 & 干预措施
HCP-Guided Exercise
Participants will schedule twice-weekly in-person visits to conduct health care provider (HCP)-supervised exercise activity for a minimum of 30 minutes. At least 3 additional times per week, participants will conduct self-directed exercise at home. Activity and other outcomes will be monitored with an Actigraph Centrepoint Insight Watch.
The HCP guided therapy will continue on a weekly basis for at least 2 weeks and up to a maximum of 4 weeks.
干预措施: HCP-Guided Exercise Training Program (Behavioral)
Control
Participants will not participate in the HCP-guided exercise intervention but will wear the Actigraph Centrepoint Insight Watch.
结局指标
主要结局
Number of Intervention Arm Participants in Compliance with HCP Exercise Intervention
时间窗: Up to Week 4
Compliance with HCP exercise intervention is defined as successful completion of at least 150 minutes of weekly moderate-to-intense physical activity over a minimum of 2 weeks for every week of the prescribed intervention (2, 3 or 4 weeks).
次要结局
- Change in Number of Tumor-Infiltrating CD8-Positive T Cells Expressing GZMB(Baseline, Final Study Visit (Between Weeks 2-4))
- Change in Number of Tumor-Infiltrating CD8-Positive T Cells(Baseline, Final Study Visit (Between Weeks 2-4))
- Change in Number of Tumor-Infiltrating CD8-Positive T Cells Expressing IL-15Ra(Baseline, Final Study Visit (Between Weeks 2-4))
- Minutes Spent in Rapid Eye Movement (REM) Sleep(Up to Week 4)
- Time Spent in Sedentary Behavior(Up to Week 4)
- Total Physical Activity Energy Expenditure(Up to Week 4)
- Number of Participants who Experience an Event that Leads to Delay in Surgical Resection(Up to Week 4)
- Change in Number of Tumor-Infiltrating CD8-Positive T Cells Expressing CD3(Baseline, Final Study Visit (Between Weeks 2-4))
- Change in Number of Circulating CD8-Positive T Cells Expressing IL-15Ra as Assessed by Flow Cytometry(Baseline, Final Study Visit (Between Weeks 2-4))
- Time Spent in Moderate-to-Vigorous Physical Activity (MVPA)(Up to Week 4)
- Average Daily MET Rates(Up to Week 4)
- Number of Participants who Experience Adverse Events (AEs)(Up to Week 4)