Pain Clinical Trial
— Y4CIPNOfficial title:
Impact of Somatic Yoga and Meditation on Fall Risk, Function, and Quality of Life for Chemotherapy-Induced Peripheral Neuropathy Syndrome in Cancer Survivors
NCT number | NCT03786055 |
Other study ID # | 2018.019 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 4, 2018 |
Est. completion date | July 31, 2019 |
Verified date | August 2019 |
Source | Stockton University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Chemotherapy-induced peripheral neuropathy syndrome (CIPN) causes significant pain in hands and feet and is an adverse effect of treatment. Few non-pharmacological interventions have been tested and individuals experience CIPN symptoms years after treatment. This is the first study to explore a somatic yoga and meditation (SYM) intervention on functional outcomes and quality of life in cancer survivors.
Status | Completed |
Enrollment | 18 |
Est. completion date | July 31, 2019 |
Est. primary completion date | July 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Cancer survivors 18 years or older - Any type or stage of cancer - Completed chemotherapy treatment - Mild Peripheral Neuropathy Symptoms Exclusion Criteria: - Active cancer disease - Currently receiving cancer treatment - Diabetes - Prior history of peripheral neuropathy from other disease - Risk factors for exercise (measured by Patient Activity Readiness Questionnaire) |
Country | Name | City | State |
---|---|---|---|
United States | Leadership Studio | Atlantic City | New Jersey |
United States | Bacharach Institute for Rehabilitation | Pomona | New Jersey |
Lead Sponsor | Collaborator |
---|---|
Stockton University |
United States,
Agarwal RP, Maroko-Afek A. Yoga into Cancer Care: A Review of the Evidence-based Research. Int J Yoga. 2018 Jan-Apr;11(1):3-29. doi: 10.4103/ijoy.IJOY_42_17. Review. — View Citation
Galantino ML, Desai K, Greene L, Demichele A, Stricker CT, Mao JJ. Impact of yoga on functional outcomes in breast cancer survivors with aromatase inhibitor-associated arthralgias. Integr Cancer Ther. 2012 Dec;11(4):313-20. doi: 10.1177/1534735411413270. Epub 2011 Jul 6. — View Citation
Galantino ML, Greene L, Daniels L, Dooley B, Muscatello L, O'Donnell L. Longitudinal impact of yoga on chemotherapy-related cognitive impairment and quality of life in women with early stage breast cancer: a case series. Explore (NY). 2012 Mar-Apr;8(2):127-35. doi: 10.1016/j.explore.2011.12.001. — View Citation
Stout NL, Silver JK, Raj VS, Rowland J, Gerber L, Cheville A, Ness KK, Radomski M, Nitkin R, Stubblefield MD, Morris GS, Acevedo A, Brandon Z, Braveman B, Cunningham S, Gilchrist L, Jones L, Padgett L, Wolf T, Winters-Stone K, Campbell G, Hendricks J, Perkin K, Chan L. Toward a National Initiative in Cancer Rehabilitation: Recommendations From a Subject Matter Expert Group. Arch Phys Med Rehabil. 2016 Nov;97(11):2006-2015. doi: 10.1016/j.apmr.2016.05.002. Epub 2016 May 27. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Vibration Sense - Biothesiometer | A calibrated biothesiometer will be used to measure vibration sense. Participants will be placed in a relaxed position in a chair and tested with the same script and application of the vibration unit to the proximal lower extremity where sensation is intact. Mid-plantar pad and the tip of the great toe will be tested via 2 trials per protocol and averaged. The amplitude is directly proportional to the square of the applied voltage and higher numbers indicate less perception of sensation. | Change from baseline sensation at 8 weeks | |
Other | Salivary Cortisol | Salivary cortisol will be collected using the Salivette device and standardized methodology with minimum invasiveness. Higher numbers indicate greater cortisol levels and higher stress | Change from baseline salivary cortisol at 8 weeks | |
Primary | Sit and Reach (SR) | The Sit and Reach Test (SR) is the most-widely used measure of hamstring and low back flexibility, examining the maximal reach an individual can make in a long-sitting position. The SR has established norms by the American College of Sports Medicine, with a score of 16 and 15 for adults 46-55 years old and 56-65 years old respectively in the 50th percentile. Individuals are asked to maintain a long-sit position on the floor while safely reaching forward as far as possible with their shoes removed, feet flat against the table, and legs straight. Three trials are averaged and higher scores indicate greater flexibility. | Change from baseline flexibility at 8 weeks | |
Primary | Forward Reach (FR) | The Functional Reach test (FR) test examines the balance of individuals with respect to the patient's limit of stability. Each participant is instructed to flex the test arm forward to 90° and to reach forward as far as possible before taking a step. The reach is determined by the total excursion of the third metacarpal from the starting point to the point just before balance is lost. An average of 3 measurements is used as the final score. FR has demonstrated strong reliability and validity for measuring postural control in reaching forward during standing. The FR test has shown criterion validity, predictive validity, test-retest reliability, and inter-rater reliability for younger and older adults. It has also been shown to possess predictive validity for falls. | Change from baseline balance at 8 weeks | |
Primary | Timed Up and Go (TUG) | The Timed Up and Go (TUG) is a standardized test that measures physical function in sitting to standing, walking and returning to the seated position. Participants are instructed to stand up from a chair, walk three meters as quickly and safely as possible, turn around, walk back and sit down. The test is timed and longer time indicates worse performance. Nine seconds is the cutoff for high risk of falls. | Change from baseline walking speed at 8 weeks | |
Secondary | Brief Pain Inventory (BPI) | The BPI is a patient reported outcome measure that assesses severity of pain, impact of pain on daily function, location of pain, pain medications and amount of pain relief in the past 24 hours or the past week. It responds to both behavioral and pharmacological pain interventions and takes 5 minutes to complete. Scoring algorithm: "worst pain" or the arithmetic mean of the four severity items can be used as measures of pain severity; the arithmetic mean of the seven interference items can be used as a measure of pain interference. Reliability: Cronbach alpha reliability ranges from 0.77 to 0.91 | Change from baseline pain at 8 weeks | |
Secondary | Patient Neurotoxicity Scale (PNQ) | Patient perception of sensation and weakness attributed to CIPN.The PNQ is two self-reflective questions and quantifies the symptoms (sensation) and perceived weakness from CIPN 1) Do you have numbness, pain, or tingling in your hands or feet? 2) Do you have weakness in your arms or legs? These two items are rated 1-5 on the following scale: 1 = No, 2 = Mild, 3 = Moderate, 4 = Moderate-to-Severe, and 5 = Severe. The PNQ total score ranges from 2 to 10, with a high total score indicating severe CIPN symptoms. A PNQ total score of 2 is defined as grade A; 3-4, as grade B; 5-6, as grade C; 7-8, as grade D; and 9-10, as grade E | Change from baseline sensation and strength at 8 weeks | |
Secondary | Perceived Stress Scale (PSS) | Each item is rated on a 5-point scale ranging from never (0) to almost always (4). Positively worded items are reverse scored, and the ratings are summed, with higher scores indicating more perceived stress. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress. ? Scores ranging from 0-13=low stress. ? Scores ranging from 14-26 = moderate stress. ? Scores ranging from 27-40 = high perceived stress. | Change from baseline stress at 8 weeks | |
Secondary | Pittsburgh Sleep Quality Index (PSQI) | The Pittsburgh Sleep Quality Index (PSQI) is an effective instrument used to measure the quality and patterns of sleep in adults. It differentiates "poor" from "good" sleep quality by measuring seven areas (components): subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction over the last month. In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality. | Change from baseline sleep at 8 weeks | |
Secondary | Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (Fact/GOG-Ntx) | The FACT/GOG-Ntx contains 11 items scored from 0-4, and scores are summed for a range of 11-44. Questions on the Ntx subscale pertain to the feeling of weakness all over, numbness or tingling in the hands or feet, and difficulty buttoning their buttons. Reliability was measured using Cronbach alpha of greater than 0.7 and higher scores indicate greater severity of symptoms. | Change from baseline quality of life at 8 weeks | |
Secondary | Falls Efficacy Scale (FES) | The FES is a 10 item scale where each item is rated on a scale of 1-10. A score of 10 signifies no confidence in these activities; a score of 1 indicates confidence. Out of a total score of 100, a score of 70 or above indicates the individual has a fear of falling. | Change from baseline fear of falling at 8 weeks |
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