Ignite Creation Date:
2024-05-06 @ 7:24 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06002269
Status:
RECRUITING
Last Update Posted:
2024-02-08
First Post:
2023-08-15
Brief Title:
A Home-based Lifestyle Intervention for Optimizing Surgical Outcomes Among Urinary Bladder Cancer Patients
Sponsor:
University of Utah
Organization:
University of Utah
Study Overview
Official Title:
A Home-based Lifestyle Intervention for Optimizing Surgical Outcomes Among Urinary Bladder Cancer Patients the BOOST Study
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BOOST
Brief Summary:
The purpose of this study is to test a randomized controlled diet and physical activity intervention designed to be simple and address barriers to participation in lifestyle intervention among 16 urinary bladder cancer patients
Aim 1 is to test the feasibility and acceptability of a novel peri-operative lifestyle intervention The Boost Box among bladder cancer patients receiving cystectomy with or without neo-adjuvant chemotherapy
Aim 2 is to measure the feasibility of collecting data on the intervention effects on complication rate nutritional status weight loss and quality of life post-surgery among bladder cancer patients receiving cystectomy neoadjuvant therapy Secondarily we will determine the magnitude of association between study group and outcomes to inform power calculations in a future well-powered trial
Participants will
attend two dietetic consultations at baseline and post-surgical recovery where nutritional status will be evaluated with patient-generated subjective global assessment PG-SGA
complete baseline questionnaires TCC FACT-BI-Cys Short 2012 FAACT Godin
receive weekly BOOST boxes
complete pre-surgery weekly BOOST check ins
complete post-surgery weekly BOOST check ins
complete an ASA food recall pre and post-surgery
complete an exercise familiarization consult
record weekly resistance and aerobic exercise performed at home
complete a 6 month follow-up questionnaire
receive compensation
Researchers will compare to a Usual Care group to determine differences that could be attributed to the BOOST Box intervention
Aim 1 is to test the feasibility and acceptability of a novel peri-operative lifestyle intervention The Boost Box among bladder cancer patients receiving cystectomy with or without neo-adjuvant chemotherapy
Aim 2 is to measure the feasibility of collecting data on the intervention effects on complication rate nutritional status weight loss and quality of life post-surgery among bladder cancer patients receiving cystectomy neoadjuvant therapy Secondarily we will determine the magnitude of association between study group and outcomes to inform power calculations in a future well-powered trial
Participants will
attend two dietetic consultations at baseline and post-surgical recovery where nutritional status will be evaluated with patient-generated subjective global assessment PG-SGA
complete baseline questionnaires TCC FACT-BI-Cys Short 2012 FAACT Godin
receive weekly BOOST boxes
complete pre-surgery weekly BOOST check ins
complete post-surgery weekly BOOST check ins
complete an ASA food recall pre and post-surgery
complete an exercise familiarization consult
record weekly resistance and aerobic exercise performed at home
complete a 6 month follow-up questionnaire
receive compensation
Researchers will compare to a Usual Care group to determine differences that could be attributed to the BOOST Box intervention
Detailed Description:
Urinary bladder cancer is the fourth leading cancer in men in the US leading to 18000 deaths among men and women annually1 The survival rate is 69 for localized disease 36 for regional disease and only 5 for metastatic disease2 Bladder cancer patients often present with non-muscle invasive bladder cancer NMIBC and are treated with chemotherapy or immunotherapy delivered locally in the bladder Patients with muscle- invasive bladder cancer or intravesical therapy-refractory disease undergo cystectomy Weight loss frailty sarcopenia and malnutrition are commonplace among urinary bladder cancer patients all being associated with treatment-related complications including susceptibility to infection poor prognosis and quality of life3 Medical nutrition therapy is indicated in this population that generally has poor diet quality4-7 to achieve or maintain a healthy body weight preserve lean body mass minimize nutrition-related side effects and maximize quality of life8-10 Yet only a handful of dietary interventions have been conducted among urinary bladder cancer patients and no studies of diet intervention coupled with exercise prescription with the goal of improving treatment outcomes in this population Pre- and postoperative nutrition support has been linked to reduced hospital length of stay11 and lower postoperative complications like infection Immunonutrition interventions which comprise of supplements or fooddrinks high in vitamin A fish oil or omega-3 fatty acids and specific amino acids like arginine have also been shown to lower postoperative complications in cystectomy patients and other cancer populations12-15 In patients receiving chemotherapy or radiation immunonutrition also appears to reduce mucositis and weight loss16 Furthermore resistance exercise promotes maintenance or increase in muscle mass particularly among individuals with sarcopenia17
Little is known about the trajectory of dietary intake after bladder cancer diagnosis and the specific nutritional needs of this population in diverse settings where health disparities exist such as among rural or socio- economically disadvantaged patients18 There is also a critical need to develop and test interventions that are simple scalable durable and cost-effective4 19 and that address food insecurity20 Given these major research gaps we will implement a novel peri-operative lifestyle intervention rooted in Social Cognitive Theory SCT21 22 that uses foodingredient menu and recipe provision coupled with resistance exercise recommendations and tools provided in the Boost Box mailed to participants over 12-weeks The intervention builds self-efficacy and behavioral capability in preparing meals to support nutrition goals and addresses social determinants of health in underserved populations by tackling food insecurity23 Community partnerships will build the foundation for scaling up lifestyle intervention for cancer patients in Utah Expanding the availability of evidence-based options for nutrition and physical activity counseling for cancer patients and survivors has been identified as a major need24 Our proposed study is multidisciplinary and community-focused by partnering with the University of Utah Center for Community Nutrition and their established partners eg Waste Less Solutions Wasatch Community Gardens Food Recovery Network Utah Food Bank Dairy West and commercial grocers like Smiths and Harmons to roll out the intervention in the community Indeed community and home-based lifestyle interventions improve physical functioning and clinical outcomes among cancer survivors and are cost-effective25 26 Delivering diet and physical activity education using a home-based Blue Apron type approach in partnership with the community is highly novel
Urinary bladder cancer is the fourth leading cancer in men in the US and accounts for over 18000 deaths among both men and women annually1 About three quarters of bladder cancer patients present with non- muscle invasive bladder cancer and are treated with chemotherapy or immunotherapy delivered locally in the bladder or cystectomy alone in intravesical-refractory or extensive disease Muscle-invasive bladder cancer treatment includes neoadjuvant cisplatin-based chemotherapy followed by radical cystectomy Cisplatin- ineligible patients proceed with cystectomy and those who are too sick or frail for cystectomy receive chemotherapy followed by local radiation Weight loss is a common occurrence post-radical cystectomy and is associated with malnutrition3 and poor overall survival34 Moreover up to 70 of bladder cancer patients particularly those with frailty present with sarcopenia a condition of reduced skeletal muscle mass and function that is an independent poor prognostic factor35 linked to medical complications and quality of life36 In all this population has a 60 complication rate by 90-days37 from urinary tract infections to bowel obstruction
Nutrition is a vital component of chemotherapy tolerability and preparation for and recovery after cystectomy38 to prevent or resolve nutrient deficiencies achieve or maintain a healthy body weight preserve lean body mass minimize nutrition-related side effects and maximize quality of life4 8-10 39 Diet quality is generally poor among adult cancer survivors in the United States4 Bladder cancer is especially prevalent in developed countries with Western style dietary patterns and high levels of obesity2 40 with significant socioeconomic and geographic disparities observed18 41 Indeed rural compared with urban residence is associated with elevated cancer-specific and other cause mortality among bladder cancer survivors41 In addition improvement in diet quality among cancer survivors undergoing dietary intervention has been found to be smaller in rural than urban patients Yet despite the biologically plausible role of diet in the etiology of bladder cancer and the potent effects of treatment on nutritional status and weight loss in this population remarkably few studies have evaluated either pre- or post-diagnosis diet in association with outcomes after bladder cancer diagnosis nor implemented dietary intervention among bladder cancer patients to optimize their treatment outcomes42
We will address this immense research gap by testing a randomized controlled diet and physical activity trial designed to address barriers to participation in lifestyle intervention among 16 urinary bladder cancer patients 50 rural 50 no college education Baseline and post-surgical recovery nutritional status will be evaluated with patient-generated subjective global assessment PG-SGA43 44 Diet will be assessed with 3-day food record during the first 6-months post-diagnosis In the intervention arm patients will be mailed a Boost Box weekly for 6-weeks before and 6-weeks after surgery prepared by our community partners containing food ingredients We will work with the University of Utah Center for Community Nutrition to mail curriculum boxes with a menu and recipes for a high protein immunonutrition-tailored diet ie arginine vitamin A and omega-3 rich foodsbeverages and resistance bands Theraband with strength training guidelines3
Little is known about the trajectory of dietary intake after bladder cancer diagnosis and the specific nutritional needs of this population in diverse settings where health disparities exist such as among rural or socio- economically disadvantaged patients18 There is also a critical need to develop and test interventions that are simple scalable durable and cost-effective4 19 and that address food insecurity20 Given these major research gaps we will implement a novel peri-operative lifestyle intervention rooted in Social Cognitive Theory SCT21 22 that uses foodingredient menu and recipe provision coupled with resistance exercise recommendations and tools provided in the Boost Box mailed to participants over 12-weeks The intervention builds self-efficacy and behavioral capability in preparing meals to support nutrition goals and addresses social determinants of health in underserved populations by tackling food insecurity23 Community partnerships will build the foundation for scaling up lifestyle intervention for cancer patients in Utah Expanding the availability of evidence-based options for nutrition and physical activity counseling for cancer patients and survivors has been identified as a major need24 Our proposed study is multidisciplinary and community-focused by partnering with the University of Utah Center for Community Nutrition and their established partners eg Waste Less Solutions Wasatch Community Gardens Food Recovery Network Utah Food Bank Dairy West and commercial grocers like Smiths and Harmons to roll out the intervention in the community Indeed community and home-based lifestyle interventions improve physical functioning and clinical outcomes among cancer survivors and are cost-effective25 26 Delivering diet and physical activity education using a home-based Blue Apron type approach in partnership with the community is highly novel
Urinary bladder cancer is the fourth leading cancer in men in the US and accounts for over 18000 deaths among both men and women annually1 About three quarters of bladder cancer patients present with non- muscle invasive bladder cancer and are treated with chemotherapy or immunotherapy delivered locally in the bladder or cystectomy alone in intravesical-refractory or extensive disease Muscle-invasive bladder cancer treatment includes neoadjuvant cisplatin-based chemotherapy followed by radical cystectomy Cisplatin- ineligible patients proceed with cystectomy and those who are too sick or frail for cystectomy receive chemotherapy followed by local radiation Weight loss is a common occurrence post-radical cystectomy and is associated with malnutrition3 and poor overall survival34 Moreover up to 70 of bladder cancer patients particularly those with frailty present with sarcopenia a condition of reduced skeletal muscle mass and function that is an independent poor prognostic factor35 linked to medical complications and quality of life36 In all this population has a 60 complication rate by 90-days37 from urinary tract infections to bowel obstruction
Nutrition is a vital component of chemotherapy tolerability and preparation for and recovery after cystectomy38 to prevent or resolve nutrient deficiencies achieve or maintain a healthy body weight preserve lean body mass minimize nutrition-related side effects and maximize quality of life4 8-10 39 Diet quality is generally poor among adult cancer survivors in the United States4 Bladder cancer is especially prevalent in developed countries with Western style dietary patterns and high levels of obesity2 40 with significant socioeconomic and geographic disparities observed18 41 Indeed rural compared with urban residence is associated with elevated cancer-specific and other cause mortality among bladder cancer survivors41 In addition improvement in diet quality among cancer survivors undergoing dietary intervention has been found to be smaller in rural than urban patients Yet despite the biologically plausible role of diet in the etiology of bladder cancer and the potent effects of treatment on nutritional status and weight loss in this population remarkably few studies have evaluated either pre- or post-diagnosis diet in association with outcomes after bladder cancer diagnosis nor implemented dietary intervention among bladder cancer patients to optimize their treatment outcomes42
We will address this immense research gap by testing a randomized controlled diet and physical activity trial designed to address barriers to participation in lifestyle intervention among 16 urinary bladder cancer patients 50 rural 50 no college education Baseline and post-surgical recovery nutritional status will be evaluated with patient-generated subjective global assessment PG-SGA43 44 Diet will be assessed with 3-day food record during the first 6-months post-diagnosis In the intervention arm patients will be mailed a Boost Box weekly for 6-weeks before and 6-weeks after surgery prepared by our community partners containing food ingredients We will work with the University of Utah Center for Community Nutrition to mail curriculum boxes with a menu and recipes for a high protein immunonutrition-tailored diet ie arginine vitamin A and omega-3 rich foodsbeverages and resistance bands Theraband with strength training guidelines3
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None