{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"2","upperLimit":"12","value":"7.333"},{"groupId":"OG001","lowerLimit":"6","upperLimit":"6","value":"6"},{"groupId":"OG002","lowerLimit":"8","upperLimit":"8","value":"8"},{"groupId":"OG003","lowerLimit":"21","upperLimit":"21","value":"21"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"1"}],"units":"Participants"}],"title":"Physical Well-Being: Baseline - Before treatment (within 6 weeks prior to the start of treatment)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"2","upperLimit":"12","value":"7.333"},{"groupId":"OG001","lowerLimit":"21","upperLimit":"21","value":"21"},{"groupId":"OG002","lowerLimit":"26","upperLimit":"26","value":"26"},{"groupId":"OG003","lowerLimit":"18.67","upperLimit":"18.67","value":"18.67"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"1"}],"units":"Participants"}],"title":"Social/Family Well-Being: Baseline-Before treatment (within 6 weeks prior to the start of treatment)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"5","upperLimit":"12","value":"7.667"},{"groupId":"OG001","lowerLimit":"2","upperLimit":"2","value":"2"},{"groupId":"OG002","lowerLimit":"7","upperLimit":"7","value":"7"},{"groupId":"OG003","lowerLimit":"24","upperLimit":"24","value":"24"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"1"}],"units":"Participants"}],"title":"Emotional Well-Being: Baseline - Before treatment (within 6 weeks prior to the start of treatment)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"13","upperLimit":"23","value":"16.333"},{"groupId":"OG001","lowerLimit":"11","upperLimit":"11","value":"11"},{"groupId":"OG002","lowerLimit":"16","upperLimit":"16","value":"16"},{"groupId":"OG003","lowerLimit":"21","upperLimit":"21","value":"21"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"1"}],"units":"Participants"}],"title":"Functional Well-Being: Baseline - Before treatment (within 6 weeks prior to the start of treatment)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"9","upperLimit":"14","value":"11.667"},{"groupId":"OG001","lowerLimit":"51","upperLimit":"51","value":"51"},{"groupId":"OG002","lowerLimit":"13","upperLimit":"13","value":"13"},{"groupId":"OG003","lowerLimit":"20","upperLimit":"20","value":"20"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"1"}],"units":"Participants"}],"title":"Additional Concerns: Baseline - Before treatment (within 6 weeks prior to the start of treatment)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"64","upperLimit":"82","value":"72.333"},{"groupId":"OG001","lowerLimit":"51","upperLimit":"51","value":"51"},{"groupId":"OG002","lowerLimit":"66","upperLimit":"66","value":"66"},{"groupId":"OG003","lowerLimit":"104.67","upperLimit":"104.67","value":"104.67"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"1"}],"units":"Participants"}],"title":"FACT-C Total Score: Baseline - Before treatment (within 6 weeks prior to the start of treatment)"},{"categories":[{"measurements":[{"groupId":"OG001","lowerLimit":"18","upperLimit":"18","value":"18"},{"groupId":"OG002","lowerLimit":"12","upperLimit":"12","value":"12"},{"groupId":"OG003","lowerLimit":"5","upperLimit":"5","value":"5"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"1"}],"units":"Participants"}],"title":"Physical Well-Being: During treatment immediately prior to Cycles 3 and 6"},{"categories":[{"measurements":[{"groupId":"OG001","lowerLimit":"20","upperLimit":"20","value":"20"},{"groupId":"OG002","lowerLimit":"21","upperLimit":"21","value":"21"},{"groupId":"OG003","lowerLimit":"23","upperLimit":"23","value":"23"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"1"}],"units":"Participants"}],"title":"Social/Family Well-Being: During treatment immediately prior to Cycles 3 and 6"},{"categories":[{"measurements":[{"groupId":"OG001","lowerLimit":"7","upperLimit":"7","value":"7"},{"groupId":"OG002","lowerLimit":"11","upperLimit":"11","value":"11"},{"groupId":"OG003","lowerLimit":"4","upperLimit":"4","value":"4"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"1"}],"units":"Participants"}],"title":"Emotional Well-Being: During treatment immediately prior to Cycles 3 and 6"},{"categories":[{"measurements":[{"groupId":"OG001","lowerLimit":"10","upperLimit":"10","value":"10"},{"groupId":"OG002","lowerLimit":"12","upperLimit":"12","value":"12"},{"groupId":"OG003","lowerLimit":"16","upperLimit":"16","value":"16"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"1"}],"units":"Participants"}],"title":"Functional Well-Being: During treatment immediately prior to Cycles 3 and 6"},{"categories":[{"measurements":[{"groupId":"OG001","lowerLimit":"8","upperLimit":"8","value":"8"},{"groupId":"OG002","lowerLimit":"13","upperLimit":"13","value":"13"},{"groupId":"OG003","lowerLimit":"13","upperLimit":"13","value":"13"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"1"}],"units":"Participants"}],"title":"Additional Concerns: During treatment immediately prior to Cycles 3 and 6"},{"categories":[{"measurements":[{"groupId":"OG001","lowerLimit":"63","upperLimit":"63","value":"63"},{"groupId":"OG002","lowerLimit":"69","upperLimit":"69","value":"69"},{"groupId":"OG003","lowerLimit":"61","upperLimit":"61","value":"61"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"1"}],"units":"Participants"}],"title":"FACT-C Total Score: During treatment immediately prior to Cycles 3 and 6"},{"categories":[{"measurements":[{"groupId":"OG001","lowerLimit":"10","upperLimit":"10","value":"10"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}],"units":"Participants"}],"title":"Physical Well-Being: After treatment (Follow-up at 4-8 weeks post-treatment)"},{"categories":[{"measurements":[{"groupId":"OG001","lowerLimit":"20","upperLimit":"20","value":"20"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}],"units":"Participants"}],"title":"Social/Family Well-Being: After treatment (Follow-up at 4-8 weeks post-treatment)"},{"categories":[{"measurements":[{"groupId":"OG001","lowerLimit":"3","upperLimit":"3","value":"3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}],"units":"Participants"}],"title":"Emotional Well-Being: After treatment (Follow-up at 4-8 weeks post-treatment)"},{"categories":[{"measurements":[{"groupId":"OG001","lowerLimit":"3","upperLimit":"3","value":"3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}],"units":"Participants"}],"title":"Functional Well-Being: After treatment (Follow-up at 4-8 weeks post-treatment)"},{"categories":[{"measurements":[{"groupId":"OG001","lowerLimit":"23","upperLimit":"23","value":"23"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}],"units":"Participants"}],"title":"Additional Concerns: After treatment (Follow-up at 4-8 weeks post-treatment)"},{"categories":[{"measurements":[{"groupId":"OG001","lowerLimit":"56","upperLimit":"56","value":"56"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}],"units":"Participants"}],"title":"FACT-C Total Score: After treatment (Follow-up at 4-8 weeks post-treatment)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"1"}],"units":"Participants"}],"description":"Outcomes from QOL comparing results before to after treatment: Quality of life is assessed using the Functional Assessment of Cancer Therapy - Colorectal (FACT-C) questionnaire, a validated instrument that measures health-related quality of life. The FACT-C consists of the following subscales: Physical Well-Being (PWB): 7 items; score range 0-28, Social/Family Well-Being (SWB): 7 items; score range 0-28, Emotional Well-Being (EWB): 6 items; score range 0-24, Functional Well-Being (FWB): 7 items; score range 0-28, Colorectal Cancer Subscale (CCS):9 items; score range 0-36.The FACT-C total score is derived by summing all five subscale scores. Total score range: 0-144. For all subscales and the total score, higher values represent better quality of life and lower values represent worse quality of life. Questionnaires are administered at baseline, immediately prior to treatment Cycles 3 and 6, and at follow-up visits. A single value (average) was calculated for \"during treatment immediate","dispersionType":"Full Range","groups":[{"description":"Ended treatment at the regular dose level: 80 intravenous (IV)/80 Intraperitoneal (IP) + 300 twice a day (BID).","id":"OG000","title":"Intravenous Paclitaxel Dose Level 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1"},{"description":"Had the planned doses for Intraperitoneal (IP) Paclitaxel (80 IP) and by mouth (PO) nilotinib (300 twice a day (BID) but declined to go up to the 80mg/m\\^2 of intravenous (IV) Paclitaxel.","id":"OG001","title":"Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1"},{"description":"Had the planned doses for intravenous (IV) and Intraperitoneal (IP) Paclitaxel (80 IV/80 IP) but had a dose reduction for Nilotinib (400 every day (QD).","id":"OG002","title":"Intravenous Paclitaxel DoseLevel 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level -1"},{"description":"Had the planned dose of Intraperitoneal (IP) Paclitaxel (80 IP) but had a dose reduction for intravenous (IV) Paclitaxel (60 IV), and a dose reduction for Nilotinib (400 every day (QD).","id":"OG003","title":"Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel DoseLevel 1, Nilotinib Dose Level -1"}],"paramType":"MEDIAN","populationDescription":"6/21 participants were analyzed because 12 participants were not treated, 2 refused further treatment and 1 was non-English speaking. 0 participants were analyzed in the Group \"Intravenous Paclitaxel Dose Level 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1\" during treatment immediately prior to Cycles 3 and 6 and after treatment (Follow-up at 4-8 weeks post-treatment) because no participants in this group completed the survey at the later timepoints (i.e.,no data collected).","reportingStatus":"POSTED","timeFrame":"Participants were followed from baseline (within 6 weeks prior to start of treatment), and immediately prior to Cycle 3 (one cycle is 21 days) and Cycle 6 and in follow-up, up to 8 weeks post-treatment","title":"Participants Quality of Life (QOL) Using the Functional Assessment of Cancer Therapy - Colorectal (FACT-C) Instrument","type":"SECONDARY","unitOfMeasure":"Score on a scale"}