{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"4.4","value":"-1.0"},{"groupId":"OG001","spread":"7.3","value":"-0.7"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"21"},{"groupId":"OG001","value":"27"}],"units":"Participants"}],"description":"The Neuropen is used to assess pressure perception. Pressure sensation will be assessed using a 10-g monofilament on the subject's dominant foot at each of the ten different sites recorded as present or absent. The proportion present was calculated for each patient at baseline and at 3 months. The difference between these proportions from baseline to 3 months was calculated for each patient. The mean of these differences was calculated within each arm and the difference of those means was then compared between arms.","dispersionType":"Standard Deviation","groups":[{"description":"Patients undergo acupuncture during chemotherapy infusion on day 1 and fluorouracil pump disconnect on day 3 of each biweekly chemotherapy infusion over 12 weeks. Patients also undergo self-administered acupressure over 11 minutes daily for 12 weeks and undergo standard of care oral cryotherapy.\n\nAcupuncture Therapy: Undergo acupuncture\n\nAcupressure Therapy: Undergo acupressure\n\nOral Cryotherapy: Undergo oral cryotherapy\n\nQuestionnaire Administration: Ancillary studies\n\nQuality-of-Life Assessment: Ancillary studies","id":"OG000","title":"Arm I (Acupuncture, Acupressure, Cryotherapy)"},{"description":"Patients undergo standard of care oral cryotherapy.\n\nOral Cryotherapy: Undergo oral cryotherapy\n\nQuestionnaire Administration: Ancillary studies\n\nQuality-of-Life Assessment: Ancillary studies","id":"OG001","title":"Arm II (Cryotherapy)"}],"paramType":"MEAN","populationDescription":"Due to missing acupuncture appointments the overall number of participants analyzed differs from patients that completed the study.","reportingStatus":"POSTED","timeFrame":"3 months","title":"Severity of CIPN: Neuropen Assessment of Patients' Perceived Pressure","type":"SECONDARY","unitOfMeasure":"proportion of present responses"}