Exercise Rehabilitation in Veteran Cancer Survivors

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Progressive Activity-Based Rehabilitation in Veteran Cancer Survivors With Chronic Pain

Conditions
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Cancer

Intervention / Treatment
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* Behavioral: Exercise Rehabilitation
* Other: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Presence of metastatic (stage IV) Life expectancy < 6 months Musculoskeletal or medical conditions which preclude participation in an exercise program

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Sequential Assignment
Interventional Model Description: Cancer survivors will be enrolled in a 6-week delayed entry control period followed by 6-week exercise rehabilitation program.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control<br>Participants maintain their current activity level. | Other: Control<br>* Participants are instructed to maintain current activity level and are monitored for changes.<br>|
| Active Comparator: Exercise Rehabilitation<br>Participants will exercise 2x/week at training facilities and at home one day a week. | Behavioral: Exercise Rehabilitation<br>* This training is designed to improve fitness, target the major muscle groups for strength, and to improve balance. Aerobic exercise of walking on a treadmill will be performed. Thera-Bands will be used for resistance exercise for the lower and upper body. Balance program includes core exercises (stepping, weight shifts, etc.) and other progressive exercises.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Visual Analog Scale Change | Scale of 0 (no pain) to 100 (worst imaginable pain) | Measured at baseline, after 6 weeks control, and after 6 week intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-Reported Outcomes Measurement System Neuropathic Pain Quality (PROMIS-PQ Neuro) Change | 0-10 numeric rating | Measured at baseline, after 6 weeks control, and after 6 week intervention | 
| Fitness Change | VO2peak | Measured at baseline, after 6 weeks control, and after 6 week intervention | 
| Strength Change | knee extensor strength | Measured at baseline, after 6 weeks control, and after 6 week intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neuropathic Pain, Exercise, Lung Cancer