For patients with certain types of bladder cancer, the removal of the bladder and the construction of an artificial bladder or reservoir are the only treatment options. Both before and after treatment, patients and caregivers face profound challenges preparing for surgery and planning for tasks during their recovery. To aid in recovery and enhance quality of life this program of research will develop and evaluate a multi-stage intervention geared towards patients and their caregivers. Part 1 of this program will have a nurse or trained health professional prepare both patients and their caregivers before treatment about the upcoming surgery. During this time the nurse will also demonstrate the necessary tools and techniques for stoma care. In addition, patients and their caregivers will receive access to a recovery website, specifically designed for bladder cancer patients to be used as a resource for after treatment. The website will be part 2 of this research and will contain important recovery information, videos about post-surgical care, testimonials by other patients and physicians and a variety of other resources. Patients and caregivers in the control group will receive the Facing Forward brochures from the National Cancer Institute in part 2. This research has been funded by the National Cancer Institute and will be the first study to address the needs of bladder cancer patients and their caregivers. The ultimate goal of the study is to reduce infections and unplanned nurse/ER visits and improve quality of life for both patients and their caregivers. This new program will be evaluated over the course of 12-months and if found successful, has the potential to be disseminated throughout the health care systems of the two study sites.
Treatment for certain types of bladder cancer (BC) involves the removal of the bladder and construction of a new voiding system and is physically and psychologically profoundly challenging for patients and caregivers. Based on investigators' published literature and extensive pilot data, patients and caregivers have extensive unmet informational, social, psychological, instrumental, and medical needs from the time of diagnosis, through treatment and recovery which are not adequately addressed by health care professionals. Investigators propose to address these unmet needs through the refinement and evaluation of a comprehensive, 2-part (in-person and web-based) intervention, geared towards the patient and caregiver. Specifically, during Aim 1, the formative phase, investigators propose to further refine the newly developed intervention components with the help of an established patient/caregiver advisory board. The intervention, Recovery Support for Bladder Cancer (RSBC), consists of a pre-treatment, in-person preparatory instructional session with a trained health care professional (Module 1) to equip patients and caregivers with the skills to adjust to the upcoming treatment and recovery period. This is followed by a post-treatment, interactive web-based program (Module 2) to provide further support for both patients and caregivers to enhance quality of life (QOL) and reduce infections and nurse/ER visits. The RSBC intervention will be evaluated in a 12-month randomized controlled trial (Aim 2) among patients and caregiver dyads (anticipated to recruit a total of 287 participants) against a time and attention comparison condition (the Facing Forward brochures). Primary outcomes for both patients and caregivers will be improved QOL, which is hypothesized to be significantly higher among participants randomized into RSBC. Secondary outcomes will be fewer infections and nurse-ER visits for patients randomized into RSBC. Aim 3 proposes moderator (i.e., age, gender, surgical diversion type) and mediator (i.e., patient activation, distress) analyses of intervention efficacy. Investigators hypothesize that RSBC will be significantly more successful among (a) older, (b) female participants, and (c) patients with a conduit diversion type. Elevated levels of patient activation (i.e., higher self-care knowledge, self-efficacy, lower distress) will mediate the intervention effects. Exploratory Aim 4 will examine the costs and potential savings associated with developing and implementing the RSBC intervention. Investigators hypothesize that initial development and implementation costs of RSBC will be offset by reduced nurse/ER visits. The scientific premise is strong and supported by an established theoretical framework, extensive pilot data and a rigorous application of clinical research methods. The proposed study is highly innovative, as it comprehensively addresses unmet needs of both patients and caregivers from pre- and (immediate) post-treatment to recovery. This is achieved through an innovative combination of in-person preparation and skill-building and web-based technology. If successful, RSBC has the potential to significantly change clinical care for patients and caregivers with BC.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
174
Intervention support is patient initiated and accessed as needed
Usual care is enhanced with the addition of the NCI Facing Forward brochure
Northwell Health
Manhasset, New York, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Quality of Life Patient: The Functional Assessment of Cancer Therapy-Bladder Cancer-Cystectomy
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
Time frame: Baseline
Quality of Life Patient: The Functional Assessment of Cancer Therapy-Bladder Cancer-Cystectomy
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
Time frame: 1 month
Quality of Life Patient: The Functional Assessment of Cancer Therapy-Bladder Cancer-Cystectomy
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
Time frame: 3 months
Quality of Life Patient: The Functional Assessment of Cancer Therapy-Bladder Cancer-Cystectomy
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
Time frame: 6 months
Quality of Life Patient: The Functional Assessment of Cancer Therapy-Bladder Cancer-Cystectomy
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
Time frame: 12 months
Quality of Life Caregiver: The Caregiver Quality of Life Index-C
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.
Time frame: Baseline
Quality of Life Caregiver: The Caregiver Quality of Life Index-C
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.
Time frame: 1 month
Quality of Life Caregiver: The Caregiver Quality of Life Index-C
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.
Time frame: 3 months
Quality of Life Caregiver: The Caregiver Quality of Life Index-C
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.
Time frame: 6 months
Quality of Life Caregiver: The Caregiver Quality of Life Index-C
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.
Time frame: 12 months
Infection Rate (Biological Factor)
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.
Time frame: 1 month
Infection Rate (Biological Factor)
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.
Time frame: 3 months
Infection Rate (Biological Factor)
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.
Time frame: 6 months
Infection Rate (Biological Factor)
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.
Time frame: 12 months
Visiting Nurse/ER Visits
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.
Time frame: 1 month
Visiting Nurse/ER Visits
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 3 months
Visiting Nurse/ER Visits
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.
Time frame: 6 months
Visiting Nurse/ER Visits
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.
Time frame: 12 months