Trial Title:
A Home-based Lifestyle Intervention for Optimizing Surgical Outcomes Among Urinary Bladder Cancer Patients
NCT ID:
NCT06002269
Condition:
Bladder Cancer
Cystectomy
Chemotherapy
Conditions: Official terms:
Urinary Bladder Neoplasms
Conditions: Keywords:
Surgery
Weight Loss
Urinary
Lifestyle
Cystectomy
Malnutrition
Chemotherapy
Diet
Exercise
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
BOOST Box intervention compared with usual care.
Primary purpose:
Prevention
Masking:
Single (Care Provider)
Masking description:
Dietitians will be masked to study group.
Intervention:
Intervention type:
Combination Product
Intervention name:
Dietary and Exercise Intervention
Description:
Participants will receive food ingredients and recipes to be made and consumed for each
meal, every day for a period of 3-6 weeks before surgery and 6-weeks after surgery. The
menu is designed as a high protein, high calorie diet meeting targets for omega-3 fatty
acids, vitamin A, and arginine (immunonutrition meal plan). In addition, participants
will receive an individualized exercise prescription to be performed at home using
theraband resistance bands.
Arm group label:
BOOST Box Intervention
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.
Detailed description:
Urinary bladder cancer is the fourth leading cancer in men in the US, leading to 18,000
deaths among men and women annually.1 The survival rate is 69% for localized disease, 36%
for regional disease, and only 5% for metastatic disease.2 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 life.3 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 life.8-10 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 stay,11 and lower postoperative
complications like infection. Immunonutrition interventions, which comprise of
supplements or food/drinks 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 populations.12-15 In patients
receiving chemotherapy or radiation, immunonutrition also appears to reduce mucositis and
weight loss.16 Furthermore, resistance exercise promotes maintenance or increase in
muscle mass, particularly among individuals with sarcopenia.17
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 patients.18
There is also a critical need to develop and test interventions that are simple,
scalable, durable, and cost-effective,4, 19 and that address food insecurity.20 Given
these major research gaps, we will implement a novel, peri-operative lifestyle
intervention rooted in Social Cognitive Theory (SCT)21, 22 that uses food/ingredient,
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 insecurity.23 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 need.24 Our proposed study is
multidisciplinary and community-focused by partnering with the University of Utah Center
for Community Nutrition and their established partners (e.g., 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-effective.25, 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 18,000 deaths among both men and women annually.1 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 survival.34 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 life.36 In all, this population has a 60% complication rate by 90-days,37
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 life.4, 8-10, 39 Diet quality is generally poor among
adult cancer survivors in the United States.4 Bladder cancer is especially prevalent in
developed countries with Western style dietary patterns and high levels of obesity,2, 40
with significant socioeconomic and geographic disparities observed.18, 41 Indeed, rural
compared with urban residence is associated with elevated cancer-specific and other cause
mortality among bladder cancer survivors.41 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 outcomes.42
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-SGA).43, 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 (i.e., arginine,
vitamin A, and omega-3 rich foods/beverages), and resistance bands (Theraband) with
strength training guidelines.3,
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Adult patients 18 years or older.
2. Newly diagnosed urinary bladder cancer patients indicated for cystectomy with or
without neo-adjuvant therapy; Treated with surgery at the Huntsman Cancer Institute
3. Have reliable, consistence access to the internet for study procedures
Inclusion of Individuals across the Lifespan: The proposed trial will enroll 20 adults
who have been diagnosed with bladder cancer. The age range of participants to be
recruited is 18 years or older. Bladder cancer is generally a disease of older age and is
exceedingly rare in children. According to the American Cancer Society, average age at
diagnosis is 73.1 Therefore, we are unable to include children in this trial.
Inclusion of Women, Minorities, and Children: It is anticipated that 20% will be female;
80% male. Racial distribution is projected to be as follows: 97% white, 1% Native
Hawaiian or Pacific Islander; 1% American Indian/ Alaska Native; 1% Asian; <1% Black.
Approximately 96% will be Non-Hispanic.
Exclusion Criteria:
1. Special dietary requirements (i.e., allergies and intolerances, or other clinically
prescribed diet).
2. Unable to provide informed consent or read, write, or fill in questionnaires in
English
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Huntsman Cancer Institute
Address:
City:
Salt Lake City
Zip:
84112
Country:
United States
Status:
Recruiting
Contact:
Last name:
Mary Playdon, PhD
Phone:
801-213-6264
Email:
Mary.Playdon@hci.utah.edu
Start date:
June 4, 2024
Completion date:
May 2026
Lead sponsor:
Agency:
University of Utah
Agency class:
Other
Source:
University of Utah
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06002269
