Trial Outcomes & Findings for Recovery Support for Bladder Cancer Patients and Caregivers (NCT NCT04055311)

Bladder cancer survivor patients and associated caregivers were recruited from Northwell Health and Fox Chase Cancer Center/Temple University Hospital between October 2018 to June 2024. The study team reviewed electronic medical records, screening physicians' schedules for eligible survivors and leveraged physician referrals for recruitment. Following identification of eligible patient survivors, their associated caregivers were also assessed for eligibility and approached for recruitment.

N = 174 participants (109 patient survivors, 65 caregivers) met study inclusion criteria and were enrolled in study. While this is not a dyad study, patients and caregivers who opted to participate were randomly assigned to the same conditions (i.e., intervention or enhanced usual care control arm). Our analyses comprised the following groups: (Intervention (Survivors), N = 47; Intervention (Caregivers), N = 31; Usual Care Enhanced (Survivors), N = 62, Usual Care Enhanced (Caregivers), N = 34.

Recovery Support for Bladder Cancer Patients and Caregivers

Bladder cancer survivor quality of life was assessed using the 42-item FACT-BL-CYS, which employed a 5-point Likert-type scale ranging from 0-4. Scale was computed as per published instructions: Higher summary and subscale scores indicated better quality of life. Median imputation at the item level was performed if at least 2/3 of items per subscales had responses. Potential score range for each subscale: Physical well-being (7 items): 0-28; Social/family well-being (7 items): 0-28; Emotional well-being (6 items): 0-24; Functional well-being (7 items): 0-28; BL-CYS well-being (15 items): 0-60. Potential score range for total score: 0-168

Bladder cancer survivor quality of life was assessed using the 42-item FACT-BL-CYS, which employed a 5-point Likert-type scale ranging from 0-4. Scale was computed as per published instructions: Higher summary and subscale scores indicated better quality of life. Median imputation at the item level was performed if at least 2/3 of items per subscales had responses. Potential score range for each subscale: Physical well-being (7 items): 0-28; Social/family well-being (7 items): 0-28; Emotional well-being (6 items): 0-24; Functional well-being (7 items): 0-28; BL-CYS well-being (15 items): 0-60. Potential score range for total score: 0-168

Bladder cancer survivor quality of life was assessed using the 42-item FACT-BL-CYS, which employed a 5-point Likert-type scale ranging from 0-4. Scale was computed as per published instructions: Higher summary and subscale scores indicated better quality of life. Median imputation at the item level was performed if at least 2/3 of items per subscales had responses. Potential score range for each subscale: Physical well-being (7 items): 0-28; Social/family well-being (7 items): 0-28; Emotional well-being (6 items): 0-24; Functional well-being (7 items): 0-28; BL-CYS well-being (15 items): 0-60. Potential score range for total score: 0-168

Bladder cancer survivor quality of life was assessed using the 42-item FACT-BL-CYS, which employed a 5-point Likert-type scale ranging from 0-4. Scale was computed as per published instructions: Higher summary and subscale scores indicated better quality of life. Median imputation at the item level was performed if at least 2/3 of items per subscales had responses. Potential score range for each subscale: Physical well-being (7 items): 0-28; Social/family well-being (7 items): 0-28; Emotional well-being (6 items): 0-24; Functional well-being (7 items): 0-28; BL-CYS well-being (15 items): 0-60. Potential score range for total score: 0-168

Bladder cancer survivor quality of life was assessed using the 42-item FACT-BL-CYS, which employed a 5-point Likert-type scale ranging from 0-4. Scale was computed as per published instructions: Higher summary and subscale scores indicated better quality of life. Median imputation at the item level was performed if at least 2/3 of items per subscales had responses. Potential score range for each subscale: Physical well-being (7 items): 0-28; Social/family well-being (7 items): 0-28; Emotional well-being (6 items): 0-24; Functional well-being (7 items): 0-28; BL-CYS well-being (15 items): 0-60. Potential score range for total score: 0-168

Caregiver quality of life was assessed using an abbreviated version of the 35-item CQOLC, (including items 1, 3, 5, 6, 7, 8, 11, 14, 19, 22, 28, and 34) and employing a 5-point Likert type scale ranging from 0-4; items were reverse scored so that a higher score indicated better quality of life. Items were summed together to get a total score, and median imputation was completed at the item level if at least 2/3 of items asked had responses (8+ items). Potential score range for total score: 0-48. Potential score range for each subscale: Disruptiveness (3 items; items 1, 3, 5): 0-12; Financial concerns (3 items; items 6, 7, 8): 0-12; Emotional distress (3 items; items 11, 14, 19): 0-12; Positive adaptation (3 items; items 22, 28, 34): 0-12.

Caregiver quality of life was assessed using an abbreviated version of the 35-item CQOLC, (including items 1, 3, 5, 6, 7, 8, 11, 14, 19, 22, 28, and 34) and employing a 5-point Likert type scale ranging from 0-4; items were reverse scored so that a higher score indicated better quality of life. Items were summed together to get a total score, and median imputation was completed at the item level if at least 2/3 of items asked had responses (8+ items). Potential score range for total score: 0-48. Potential score range for each subscale: Disruptiveness (3 items; items 1, 3, 5): 0-12; Financial concerns (3 items; items 6, 7, 8): 0-12; Emotional distress (3 items; items 11, 14, 19): 0-12; Positive adaptation (3 items; items 22, 28, 34): 0-12.

Caregiver quality of life was assessed using an abbreviated version of the 35-item CQOLC, (including items 1, 3, 5, 6, 7, 8, 11, 14, 19, 22, 28, and 34) and employing a 5-point Likert type scale ranging from 0-4; items were reverse scored so that a higher score indicated better quality of life. Items were summed together to get a total score, and median imputation was completed at the item level if at least 2/3 of items asked had responses (8+ items). Potential score range for total score: 0-48. Potential score range for each subscale: Disruptiveness (3 items; items 1, 3, 5): 0-12; Financial concerns (3 items; items 6, 7, 8): 0-12; Emotional distress (3 items; items 11, 14, 19): 0-12; Positive adaptation (3 items; items 22, 28, 34): 0-12.

Caregiver quality of life was assessed using an abbreviated version of the 35-item CQOLC, (including items 1, 3, 5, 6, 7, 8, 11, 14, 19, 22, 28, and 34) and employing a 5-point Likert type scale ranging from 0-4; items were reverse scored so that a higher score indicated better quality of life. Items were summed together to get a total score, and median imputation was completed at the item level if at least 2/3 of items asked had responses (8+ items). Potential score range for total score: 0-48. Potential score range for each subscale: Disruptiveness (3 items; items 1, 3, 5): 0-12; Financial concerns (3 items; items 6, 7, 8): 0-12; Emotional distress (3 items; items 11, 14, 19): 0-12; Positive adaptation (3 items; items 22, 28, 34): 0-12.

Caregiver quality of life was assessed using an abbreviated version of the 35-item CQOLC, (including items 1, 3, 5, 6, 7, 8, 11, 14, 19, 22, 28, and 34) and employing a 5-point Likert type scale ranging from 0-4; items were reverse scored so that a higher score indicated better quality of life. Items were summed together to get a total score, and median imputation was completed at the item level if at least 2/3 of items asked had responses (8+ items). Potential score range for total score: 0-48. Potential score range for each subscale: Disruptiveness (3 items; items 1, 3, 5): 0-12; Financial concerns (3 items; items 6, 7, 8): 0-12; Emotional distress (3 items; items 11, 14, 19): 0-12; Positive adaptation (3 items; items 22, 28, 34): 0-12.

Infection rate was assessed through self-report and verified through electronic medical chart review for each patient. Only patients with complete data on infection status (i.e., noted as having an "infection present" or "no infection present") were included in our analysis.

Infection rate was assessed through self-report and verified through electronic medical chart review for each patient. Only patients with complete data on infection status (i.e., noted as having an "infection present" or "no infection present") were included in our analysis.

Infection rate was assessed through self-report and verified through electronic medical chart review for each patient. Only patients with complete data on infection status (i.e., noted as having an "infection present" or "no infection present") were included in our analysis.

Infection rate was assessed through self-report and verified through electronic medical chart review for each patient. Only patients with complete data on infection status (i.e., noted as having an "infection present" or "no infection present") were included in our analysis.

Nurse or ER visits were assessed through self-report and verified through electronic medical record chart review for each patient. Only patients with complete data on ER/nurse visits (i.e., noted as having "ER or nurse visit" or "No ER or nurse visit" were included in our analysis.

Nurse or ER visits were assessed through self-report and verified through electronic medical record chart review for each patient. Only patients with complete data on ER/nurse visits (i.e., noted as having "ER or nurse visit" or "No ER or nurse visit" were included in our analysis.

Nurse or ER visits were assessed through self-report and verified through electronic medical record chart review for each patient. Only patients with complete data on ER/nurse visits (i.e., noted as having "ER or nurse visit" or "No ER or nurse visit" were included in our analysis.

Nurse or ER visits were assessed through self-report and verified through electronic medical record chart review for each patient. Only patients with complete data on ER/nurse visits (i.e., noted as having "ER or nurse visit" or "No ER or nurse visit" were included in our analysis.

Costs relative to the development, implementation \& maintenance of the intervention and cost of post-treatment care from the medical and billing records.

Costs relative to the development, implementation \& maintenance of the intervention and cost of post-treatment care from the medical and billing records.