Progressive Activity-Based Rehabilitation in Veteran Cancer Survivors With Chronic Pain
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Pain Visual Analog Scale Change
研究概览
简要总结
Exercise rehabilitation has the potential as a non-pharmacological approach to reduce persistent neuropathic pain in Veterans with lung cancer. By examining the effects of exercise training in Veteran cancer survivors with NSCLC, there is the potential to revolutionize care for a: common, debilitating, and inadequately treated symptom in a growing population. This could lead to a larger investigation to fill critical gaps in the literature and at the same time help discover a new model of care for Veterans with chronic pain. The ultimate goal is to reduce this type of pain for the growing population of cancer survivors while simultaneously reducing the need for problematic opioid management.
详细描述
Persistent or chronic neuropathic pain, either post-thoracotomy persistent pain (PTPP) or chemotherapy-induced peripheral neuropathy (CIPN) occurs in a majority of lung cancer patients. Thus, not only is this neuropathic pain widespread; there is no way to prevent its development, and long-term use of opioids for control of symptoms could result in addiction. Ultimately, PTPP and CIPN can lead to long-term suffering and disability during the post-treatment phase.(NSCLC), which represents about 85% of lung cancer cases.This is the first project of its kind and the potential impact of this research is large, because exercise training will be a prescription and the first approach for which NSCLC survivors can self-manage chronic neuropathic pain. The ultimate goal of the investigators' work is to reduce neuropathic pain for the growing population of cancer survivors while simultaneously reducing the need for problematic pharmacologic management. Therefore, results of this study have potential for high impact on symptom care because it will allow effective neuropathic pain treatment to be in full control of the Veteran, and likely restore function that is lost during the chronic pain experience.
Specific Aims:
- To determine the feasibility of conducting an exercise rehabilitation intervention in Veterans with NSCLC and PTPP or CIPN.
- To determine the effects of a VAMHCS-supervised activity rehabilitation program on chronic pain compared to delayed control.
- To assess changes in fitness, strength, physical function, fatigue, and quality of life (QoL) after activity-based rehabilitation compared to control period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 60-80 years
- •Diagnosis with lung cancer
- •History of treatment with either thoracotomy procedure or neurotoxic chemotherapy or both
- •Completion of thoracotomy or chemotherapy > or = 6 months
- •Ability to walk on a treadmill
- •Karnofsky performance status > 70
- •Score > 1 Neuropathic Pain Scale
排除标准
- •Presence of metastatic (stage IV)
- •Life expectancy < 6 months
- •Musculoskeletal or medical conditions which preclude participation in an exercise program
研究组 & 干预措施
Control
Participants maintain their current activity level.
干预措施: Control (Other)
Exercise Rehabilitation
Participants will exercise 2x/week at training facilities and at home one day a week.
干预措施: Exercise Rehabilitation (Behavioral)
结局指标
主要结局
Pain Visual Analog Scale Change
时间窗: Measured at baseline, after 6 weeks control, and after 6 week intervention
Scale of 0 (no pain) to 100 (worst imaginable pain)
次要结局
- Fitness Change(Measured at baseline, after 6 weeks control, and after 6 week intervention)
- Patient-Reported Outcomes Measurement System Neuropathic Pain Quality (PROMIS-PQ Neuro) Change(Measured at baseline, after 6 weeks control, and after 6 week intervention)
- Strength Change(Measured at baseline, after 6 weeks control, and after 6 week intervention)