xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06002269</url>
    </required_header>
    <id_info>
      <org_study_id>00150155</org_study_id>
      <nct_id>NCT06002269</nct_id>
    </id_info>
    <brief_title>A Home-based Lifestyle Intervention for Optimizing Surgical Outcomes Among Urinary Bladder Cancer Patients</brief_title>
    <acronym>BOOST</acronym>
    <official_title>A Home-based Lifestyle Intervention for Optimizing Surgical Outcomes Among Urinary Bladder Cancer Patients: the BOOST Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Utah</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Utah</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this study is to test a randomized, controlled diet and physical activity&#xD;
        intervention designed to be simple and address barriers to participation in lifestyle&#xD;
        intervention among 16 urinary bladder cancer patients.&#xD;
  &#xD;
        Aim 1 is to test the feasibility and acceptability of a novel, peri-operative lifestyle&#xD;
        intervention, &quot;The Boost Box&quot;, among bladder cancer patients receiving cystectomy with or&#xD;
        without neo-adjuvant chemotherapy.&#xD;
  &#xD;
        Aim 2 is to measure the feasibility of collecting data on the intervention effects on&#xD;
        complication rate, nutritional status, weight loss, and quality of life post-surgery among&#xD;
        bladder cancer patients receiving cystectomy ± neoadjuvant therapy. Secondarily, we will&#xD;
        determine the magnitude of association between study group and outcomes to inform power&#xD;
        calculations in a future, well-powered trial.&#xD;
  &#xD;
        Participants will:&#xD;
  &#xD;
          -  attend two dietetic consultations at baseline and post-surgical recovery where&#xD;
             nutritional status will be evaluated with patient-generated subjective global assessment&#xD;
             (PG-SGA)&#xD;
  &#xD;
          -  complete baseline questionnaires (TCC, FACT-BI-Cys, Short 2012, FAACT, Godin)&#xD;
  &#xD;
          -  receive weekly BOOST boxes&#xD;
  &#xD;
          -  complete pre-surgery weekly BOOST check ins&#xD;
  &#xD;
          -  complete post-surgery weekly BOOST check ins&#xD;
  &#xD;
          -  complete an ASA food recall pre and post-surgery&#xD;
  &#xD;
          -  complete an exercise familiarization consult&#xD;
  &#xD;
          -  record weekly resistance and aerobic exercise performed at home&#xD;
  &#xD;
          -  complete a 6 month follow-up questionnaire&#xD;
  &#xD;
          -  receive compensation&#xD;
  &#xD;
        Researchers will compare to a Usual Care group to determine differences that could be&#xD;
        attributed to the BOOST Box intervention.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Urinary bladder cancer is the fourth leading cancer in men in the US, leading to 18,000&#xD;
        deaths among men and women annually.1 The survival rate is 69% for localized disease, 36% for&#xD;
        regional disease, and only 5% for metastatic disease.2 Bladder cancer patients often present&#xD;
        with non-muscle invasive bladder cancer (NMIBC) and are treated with chemotherapy or&#xD;
        immunotherapy delivered locally in the bladder. Patients with muscle- invasive bladder cancer&#xD;
        or intravesical therapy-refractory disease undergo cystectomy. Weight loss, frailty,&#xD;
        sarcopenia, and malnutrition are commonplace among urinary bladder cancer patients, all being&#xD;
        associated with treatment-related complications including susceptibility to infection, poor&#xD;
        prognosis and quality of life.3 Medical nutrition therapy is indicated in this population&#xD;
        that generally has poor diet quality4-7 to achieve or maintain a healthy body weight,&#xD;
        preserve lean body mass, minimize nutrition-related side effects, and maximize quality of&#xD;
        life.8-10 Yet, only a handful of dietary interventions have been conducted among urinary&#xD;
        bladder cancer patients, and no studies of diet intervention coupled with exercise&#xD;
        prescription, with the goal of improving treatment outcomes in this population. Pre- and&#xD;
        postoperative nutrition support has been linked to reduced hospital length of stay,11 and&#xD;
        lower postoperative complications like infection. Immunonutrition interventions, which&#xD;
        comprise of supplements or food/drinks high in vitamin A, fish oil or omega-3 fatty acids,&#xD;
        and specific amino acids like arginine, have also been shown to lower postoperative&#xD;
        complications in cystectomy patients and other cancer populations.12-15 In patients receiving&#xD;
        chemotherapy or radiation, immunonutrition also appears to reduce mucositis and weight&#xD;
        loss.16 Furthermore, resistance exercise promotes maintenance or increase in muscle mass,&#xD;
        particularly among individuals with sarcopenia.17&#xD;
  &#xD;
        Little is known about the trajectory of dietary intake after bladder cancer diagnosis, and&#xD;
        the specific nutritional needs of this population in diverse settings where health&#xD;
        disparities exist, such as among rural or socio- economically disadvantaged patients.18 There&#xD;
        is also a critical need to develop and test interventions that are simple, scalable, durable,&#xD;
        and cost-effective,4, 19 and that address food insecurity.20 Given these major research gaps,&#xD;
        we will implement a novel, peri-operative lifestyle intervention rooted in Social Cognitive&#xD;
        Theory (SCT)21, 22 that uses food/ingredient, menu and recipe provision coupled with&#xD;
        resistance exercise recommendations and tools provided in the &quot;Boost Box&quot;, mailed to&#xD;
        participants over 12-weeks. The intervention builds self-efficacy and behavioral capability&#xD;
        in preparing meals to support nutrition goals and addresses social determinants of health in&#xD;
        underserved populations by tackling food insecurity.23 Community partnerships will build the&#xD;
        foundation for scaling up lifestyle intervention for cancer patients in Utah. Expanding the&#xD;
        availability of evidence-based options for nutrition and physical activity counseling for&#xD;
        cancer patients and survivors has been identified as a major need.24 Our proposed study is&#xD;
        multidisciplinary and community-focused by partnering with the University of Utah Center for&#xD;
        Community Nutrition and their established partners (e.g., Waste Less Solutions, Wasatch&#xD;
        Community Gardens, Food Recovery Network, Utah Food Bank, Dairy West, and commercial grocers&#xD;
        like Smiths and Harmons) to roll out the intervention in the community. Indeed, community and&#xD;
        home-based lifestyle interventions improve physical functioning and clinical outcomes among&#xD;
        cancer survivors and are cost-effective.25, 26 Delivering diet and physical activity&#xD;
        education using a home-based 'Blue Apron' type approach in partnership with the community is&#xD;
        highly novel.&#xD;
  &#xD;
        Urinary bladder cancer is the fourth leading cancer in men in the US and accounts for over&#xD;
        18,000 deaths among both men and women annually.1 About three quarters of bladder cancer&#xD;
        patients present with non- muscle invasive bladder cancer and are treated with chemotherapy&#xD;
        or immunotherapy delivered locally in the bladder, or cystectomy alone in&#xD;
        intravesical-refractory or extensive disease. Muscle-invasive bladder cancer treatment&#xD;
        includes neoadjuvant cisplatin-based chemotherapy followed by radical cystectomy. Cisplatin-&#xD;
        ineligible patients proceed with cystectomy and those who are too sick or frail for&#xD;
        cystectomy receive chemotherapy followed by local radiation. Weight loss is a common&#xD;
        occurrence post-radical cystectomy, and is associated with malnutrition3 and poor overall&#xD;
        survival.34 Moreover, up to 70% of bladder cancer patients, particularly those with frailty,&#xD;
        present with sarcopenia, a condition of reduced skeletal muscle mass and function that is an&#xD;
        independent poor prognostic factor35 linked to medical complications and quality of life.36&#xD;
        In all, this population has a 60% complication rate by 90-days,37 from urinary tract&#xD;
        infections to bowel obstruction.&#xD;
  &#xD;
        Nutrition is a vital component of chemotherapy tolerability and preparation for and recovery&#xD;
        after cystectomy38 to prevent or resolve nutrient deficiencies, achieve or maintain a healthy&#xD;
        body weight, preserve lean body mass, minimize nutrition-related side effects, and maximize&#xD;
        quality of life.4, 8-10, 39 Diet quality is generally poor among adult cancer survivors in&#xD;
        the United States.4 Bladder cancer is especially prevalent in developed countries with&#xD;
        Western style dietary patterns and high levels of obesity,2, 40 with significant&#xD;
        socioeconomic and geographic disparities observed.18, 41 Indeed, rural compared with urban&#xD;
        residence is associated with elevated cancer-specific and other cause mortality among bladder&#xD;
        cancer survivors.41 In addition, improvement in diet quality among cancer survivors&#xD;
        undergoing dietary intervention has been found to be smaller in rural than urban patients.&#xD;
        Yet, despite the biologically plausible role of diet in the etiology of bladder cancer, and&#xD;
        the potent effects of treatment on nutritional status and weight loss in this population,&#xD;
        remarkably few studies have evaluated either pre- or post-diagnosis diet in association with&#xD;
        outcomes after bladder cancer diagnosis, nor implemented dietary intervention among bladder&#xD;
        cancer patients to optimize their treatment outcomes.42&#xD;
  &#xD;
        We will address this immense research gap by testing a randomized, controlled diet and&#xD;
        physical activity trial designed to address barriers to participation in lifestyle&#xD;
        intervention among 16 urinary bladder cancer patients (50% rural; 50% no college education).&#xD;
        Baseline and post-surgical recovery nutritional status will be evaluated with&#xD;
        patient-generated subjective global assessment (PG-SGA).43, 44 Diet will be assessed with&#xD;
        3-day food record during the first 6-months post-diagnosis. In the intervention arm, patients&#xD;
        will be mailed a &quot;Boost Box&quot; weekly for 6-weeks before and 6-weeks after surgery, prepared by&#xD;
        our community partners, containing food ingredients. We will work with the University of Utah&#xD;
        Center for Community Nutrition to mail curriculum boxes with a menu and recipes for a high&#xD;
        protein, immunonutrition-tailored diet (i.e., arginine, vitamin A, and omega-3 rich&#xD;
        foods/beverages), and resistance bands (Theraband) with strength training guidelines.3,&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">October 2025</completion_date>
    <primary_completion_date type="Anticipated">October 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>BOOST Box intervention compared with usual care.</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Single (Care Provider)</masking>
      <masking_description>Dietitians will be masked to study group.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Feasibility of BOOST Box Intervention</measure>
      <time_frame>From enrollment to the 6-month follow-up survey</time_frame>
      <description>Feasibility of a novel, peri-operative lifestyle intervention, &quot;The Boost Box&quot;, among bladder cancer patients receiving cystectomy with or without neo-adjuvant chemotherapy.&#xD;
  Feasibility metrics include: % consented/referred; attrition as a function of time; % questionnaires completed; % meals prepared and consumed. Feasibility criteria: &gt;70% patients consented and retained; completed all questionnaires; prepared/consumed Boost Box meals ≥5/7 days/week; and adhered to resistance band exercise ≥2 days/week. Fidelity criteria: 90% protocol checklist items delivered as intended.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Acceptability of BOOST Box Intervention</measure>
      <time_frame>From enrollment to the 6-month follow-up survey</time_frame>
      <description>Acceptability of a novel, peri-operative lifestyle intervention, &quot;The Boost Box&quot;, among bladder cancer patients receiving cystectomy with or without neo-adjuvant chemotherapy.&#xD;
  Acceptability of the intervention delivery and menus/recipes will be evaluated by administering an anonymous questionnaire incorporating both Likert scale questions and space for open-ended responses.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Malnutrition assessment</measure>
      <time_frame>mPG-SGA, FAACT, and Short 2012 at baseline and then mPG-SGA and FAACT again six weeks post-surgery. ASA24 during six weeks pre and post-surgery</time_frame>
      <description>Surveys and Questionnaires used will be the Modified Patient-Generated Subjective Global Assessment (mPG-SGA), Functional Assessment of Anorexia and Cachexia Therapy (FAACT), U.S.Household Food Security Survey Module: Six Item Short Form (Short 2012), and Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA24) food consumption log to calculate a Healthy Eating Index (HEI) which will define diet quality (a higher score indicates a healthier diet).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Surgical complication rate</measure>
      <time_frame>30 and 60 days post-surgery</time_frame>
      <description>The following information is to be abstracted from medical charts: 30- and 90-day post-surgery complication rates including wound infections; Urinary Tract Infection (UTI); infectious complications; blood clots; readmissions; failure to thrive; dehydration; re-operations.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Body weight</measure>
      <time_frame>From enrollment to the 6-month follow-up survey</time_frame>
      <description>Participant weight measurements will be collected through participant self-reporting using a digital scale provided by the study and through medical record abstraction.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of Life (Physical, social, emotional, functional well-being, and a bladder cancer subscale)</measure>
      <time_frame>FACT-BI-Cys used from baseline to the 6-month follow-up survey</time_frame>
      <description>Questionnaire used will be the Functional Assessment of Cancer Therapy - Bladder - Cystectomy (FACT-Bl-Cys).</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Bladder Cancer</condition>
    <condition>Cystectomy</condition>
    <condition>Chemotherapy</condition>
    <arm_group>
      <arm_group_label>BOOST Box Intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Baseline: Questionnaires (FACT-Bl-Cys, mPG-SGA, Short 2012, FAACT, Godin, TCC), exercise prescription, compensation.&#xD;
  Pre-Surgery: Dietitian consultation, at least 3-weeks and up to 6-weeks of Boost Box deliveries and check-ins (nutritional intervention), up to 6 weeks of exercise intervention and logs, ASA Food Record (x2), compensation Post-Surgery: post-surgery surveys once (FACT-Bl-Cys, mPG-SGA, FAACT, Godin), 6 weeks of Boost Box deliveries and check-ins (nutritional intervention), 6 weeks of exercise intervention and logs, weekly hunger check-in, ASA Food Record (x2), Dietitian consultation, compensation.&#xD;
  Follow-up (estimated 6 months after baseline) : 6-month questionnaire, compensation.&#xD;
  Compensation total: up to $100 via electronic gift card.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Usual Care</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Baseline: Questionnaires (FACT-Bl-Cys, mPG-SGA, Short 2012, FAACT, Godin, TCC), compensation.&#xD;
  Pre-Surgery: Dietitian consultation, ASA Food Record (x2), compensation. Post-Surgery: post-surgery surveys once (FACT-Bl-Cys, mPG-SGA, FAACT, Godin), Dietitian consultation, ASA Food Record (x2), compensation.&#xD;
  Follow-up (estimated 6 months after baseline): 6-month questionnaire, compensation.&#xD;
  Compensation total: up to $100 via electronic gift card.</description>
    </arm_group>
    <intervention>
      <intervention_type>Combination Product</intervention_type>
      <intervention_name>Dietary and Exercise Intervention</intervention_name>
      <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.</description>
      <arm_group_label>BOOST Box Intervention</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Adult patients 18 years or older.&#xD;
  &#xD;
            2. Newly diagnosed urinary bladder cancer patients indicated for cystectomy with or&#xD;
               without neo-adjuvant therapy; Treated with surgery at the Huntsman Cancer Institute&#xD;
  &#xD;
            3. Have reliable, consistence access to the internet for study procedures&#xD;
  &#xD;
          Inclusion of Individuals across the Lifespan: The proposed trial will enroll 20 adults who&#xD;
          have been diagnosed with bladder cancer. The age range of participants to be recruited is&#xD;
          18 years or older. Bladder cancer is generally a disease of older age and is exceedingly&#xD;
          rare in children. According to the American Cancer Society, average age at diagnosis is&#xD;
          73.1 Therefore, we are unable to include children in this trial.&#xD;
  &#xD;
          Inclusion of Women, Minorities, and Children: It is anticipated that 20% will be female;&#xD;
          80% male. Racial distribution is projected to be as follows: 97% white, 1% Native Hawaiian&#xD;
          or Pacific Islander; 1% American Indian/ Alaska Native; 1% Asian; &lt;1% Black. Approximately&#xD;
          96% will be Non-Hispanic.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Special dietary requirements (i.e., allergies and intolerances, or other clinically&#xD;
               prescribed diet).&#xD;
  &#xD;
            2. Unable to provide informed consent or read, write, or fill in questionnaires in&#xD;
               English&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Mary C Playdon, PhD, MPH</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Utah NUIP Department and Huntsman Cancer Institute</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Mary C Playdon, PhD, MPH</last_name>
      <phone>801-213-6264</phone>
      <email>mary.playdon@hci.utah.edu</email>
    </overall_contact>
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    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 15, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>September 13, 2023</last_update_submitted>
    <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Utah</investigator_affiliation>
      <investigator_full_name>Mary Playdon</investigator_full_name>
      <investigator_title>Assistant Professor (Nutrition &amp; Integrative Physiology)</investigator_title>
    </responsible_party>
    <keyword>Surgery</keyword>
    <keyword>Weight Loss</keyword>
    <keyword>Urinary</keyword>
    <keyword>Lifestyle</keyword>
    <keyword>Cystectomy</keyword>
    <keyword>Malnutrition</keyword>
    <keyword>Chemotherapy</keyword>
    <keyword>Diet</keyword>
    <keyword>Exercise</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Urinary Bladder Neoplasms</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06002269
  org study id: 00150155
  nct id: NCT06002269
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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,
  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.
  measure: Feasibility of BOOST Box Intervention
  time frame: From enrollment to the 6-month follow-up survey
  description: Feasibility of a novel, peri-operative lifestyle intervention, "The Boost Box", among bladder cancer patients receiving cystectomy with or without neo-adjuvant chemotherapy.
  Feasibility metrics include: % consented/referred; attrition as a function of time; % questionnaires completed; % meals prepared and consumed. Feasibility criteria: >70% patients consented and retained; completed all questionnaires; prepared/consumed Boost Box meals ≥5/7 days/week; and adhered to resistance band exercise ≥2 days/week. Fidelity criteria: 90% protocol checklist items delivered as intended.
  measure: Acceptability of BOOST Box Intervention
  time frame: From enrollment to the 6-month follow-up survey
  description: Acceptability of a novel, peri-operative lifestyle intervention, "The Boost Box", among bladder cancer patients receiving cystectomy with or without neo-adjuvant chemotherapy.
  Acceptability of the intervention delivery and menus/recipes will be evaluated by administering an anonymous questionnaire incorporating both Likert scale questions and space for open-ended responses.
  measure: Malnutrition assessment
  time frame: mPG-SGA, FAACT, and Short 2012 at baseline and then mPG-SGA and FAACT again six weeks post-surgery. ASA24 during six weeks pre and post-surgery
  description: Surveys and Questionnaires used will be the Modified Patient-Generated Subjective Global Assessment (mPG-SGA), Functional Assessment of Anorexia and Cachexia Therapy (FAACT), U.S.Household Food Security Survey Module: Six Item Short Form (Short 2012), and Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA24) food consumption log to calculate a Healthy Eating Index (HEI) which will define diet quality (a higher score indicates a healthier diet).
  measure: Surgical complication rate
  time frame: 30 and 60 days post-surgery
  description: The following information is to be abstracted from medical charts: 30- and 90-day post-surgery complication rates including wound infections; Urinary Tract Infection (UTI); infectious complications; blood clots; readmissions; failure to thrive; dehydration; re-operations.
  measure: Body weight
  time frame: From enrollment to the 6-month follow-up survey
  description: Participant weight measurements will be collected through participant self-reporting using a digital scale provided by the study and through medical record abstraction.
  measure: Quality of Life (Physical, social, emotional, functional well-being, and a bladder cancer subscale)
  time frame: FACT-BI-Cys used from baseline to the 6-month follow-up survey
  description: Questionnaire used will be the Functional Assessment of Cancer Therapy - Bladder - Cystectomy (FACT-Bl-Cys).
  arm group label: BOOST Box Intervention
  arm group type: Experimental
  description: Baseline: Questionnaires (FACT-Bl-Cys, mPG-SGA, Short 2012, FAACT, Godin, TCC), exercise prescription, compensation.
  Pre-Surgery: Dietitian consultation, at least 3-weeks and up to 6-weeks of Boost Box deliveries and check-ins (nutritional intervention), up to 6 weeks of exercise intervention and logs, ASA Food Record (x2), compensation Post-Surgery: post-surgery surveys once (FACT-Bl-Cys, mPG-SGA, FAACT, Godin), 6 weeks of Boost Box deliveries and check-ins (nutritional intervention), 6 weeks of exercise intervention and logs, weekly hunger check-in, ASA Food Record (x2), Dietitian consultation, compensation.
  Follow-up (estimated 6 months after baseline) : 6-month questionnaire, compensation.
  Compensation total: up to $100 via electronic gift card.
  arm group label: Usual Care
  arm group type: No Intervention
  description: Baseline: Questionnaires (FACT-Bl-Cys, mPG-SGA, Short 2012, FAACT, Godin, TCC), compensation.
  Pre-Surgery: Dietitian consultation, ASA Food Record (x2), compensation. Post-Surgery: post-surgery surveys once (FACT-Bl-Cys, mPG-SGA, FAACT, Godin), Dietitian consultation, ASA Food Record (x2), compensation.
  Follow-up (estimated 6 months after baseline): 6-month questionnaire, compensation.
  Compensation total: up to $100 via electronic gift card.
  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
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Mary C Playdon, PhD, MPH
  role: Principal Investigator
  affiliation: University of Utah NUIP Department and Huntsman Cancer Institute
  last name: Mary C Playdon, PhD, MPH
  phone: 801-213-6264
  email: mary.playdon@hci.utah.edu
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  responsible party type: Principal Investigator
  investigator affiliation: University of Utah
  investigator full name: Mary Playdon
  investigator title: Assistant Professor (Nutrition & Integrative Physiology)
  mesh term: Urinary Bladder Neoplasms
  sharing ipd: No