Exercise Rehabilitation in Veteran Cancer Survivors
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|ClinicalTrials.gov Identifier: NCT03621813|
Recruitment Status : Not yet recruiting
First Posted : August 8, 2018
Last Update Posted : November 30, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cancer||Behavioral: Exercise Rehabilitation Other: Control||Not Applicable|
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.
- 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, and sensory thresholds (thermal, static, and dynamic) 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||Cancer survivors will be enrolled in a 6-week delayed entry control period followed by 6-week exercise rehabilitation program.|
|Official Title:||Progressive Activity-Based Rehabilitation in Veteran Cancer Survivors With Chronic Pain|
|Estimated Study Start Date :||January 2, 2019|
|Estimated Primary Completion Date :||December 30, 2021|
|Estimated Study Completion Date :||December 30, 2022|
Participants maintain their current activity level.
Participants are instructed to maintain current activity level and are monitored for changes.
Active Comparator: Exercise Rehabilitation
Participants will exercise 2x/week at training facilities and at home one day a week.
Behavioral: Exercise Rehabilitation
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.
- Pain Visual Analog Scale Change [ Time Frame: Measured at baseline, after 6 weeks control, and after 6 week intervention ]Scale of 0 (no pain) to 100 (worst imaginable pain)
- Patient-Reported Outcomes Measurement System Neuropathic Pain Quality (PROMIS-PQ Neuro) Change [ Time Frame: Measured at baseline, after 6 weeks control, and after 6 week intervention ]0-10 numeric rating
- Quantitative Sensory Testing Change [ Time Frame: Measured at baseline, after 6 weeks control, and after 6 week intervention ]thermal, mechanical, and vibration sensation
- Fitness Change [ Time Frame: Measured at baseline, after 6 weeks control, and after 6 week intervention ]VO2peak
- Strength Change [ Time Frame: Measured at baseline, after 6 weeks control, and after 6 week intervention ]knee extensor strength
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03621813
|Contact: Alice S Ryan, PhD||(410) 605-7851||Alice.Ryan@va.gov|
|Contact: Lynda C Robey||(410) 605-7000 ext email@example.com|
|United States, Maryland|
|Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD||Not yet recruiting|
|Baltimore, Maryland, United States, 21201|
|Contact: Alice S Ryan, PhD 410-605-7851 Alice.Ryan@va.gov|
|Principal Investigator: Alice S. Ryan, PhD|
|Principal Investigator:||Alice S. Ryan, PhD||Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD|