Bladder CancerSTEPPNCT02880176
Steps to Eliminate Postoperative Problems
A study testing Financial Incentive to Increase Ambulation in people with Bladder Cancer, run by University of Pennsylvania at 1 site in United States.
Trial summary
Radical cystectomy with urinary diversion is associated with substantial perioperative morbidity, including deep venous thrombosis, prolonged ileus, and postoperative functional decline. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Financial Incentive to Increase Ambulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to Feb 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Planning to undergo radical cystectomy (either with ileal conduit, Indiana pouch, neobladder (e.g., Studer or Hautmann pouch) at the University of Pennsylvania
- Patient has been diagnosed with bladder cancer
- Patient is at least 21 years of age
- Patient is ambulatory with baseline ECOG performance status less than or equal to 2
Who cannot join
- Patient knows he or she will be unable or unwilling to use a mobile device and online tool to upload activity data
- Poor preoperative performance status (ECOG 3 or greater)
- Plan for cystectomy without cutaneous ureterostomies (without a bowel diversion)
- Non-English speakers
- Patient is non-ambulatory
- Patient is incapable of consenting himself or herself prior to surgery (Because participating in this trial involves ongoing effort on the part of the subject, patients who are incapable of consenting for themselves at baseline are excluded)
- Patients who do not have at least 24 hours of pre-operation ambulation data
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Radical cystectomy with urinary diversion is associated with substantial perioperative morbidity, including deep venous thrombosis, prolonged ileus, and postoperative functional decline. Post-operative morbidity after cystectomy prolongs the length of stay, increases the risk of readmission, and adds substantially to health care costs. Protocols that emphasize early and frequent ambulation after surgery decreases post-operative morbidity, but poor patient adherence diminishes the effectiveness of these protocols, which are currently implemented only during the hospital stay. Financial incentives overcome present bias and offer a novel and practical approach to increasing ambulation during the post-operative period in the hospital and also after discharge. This application proposes a pilot randomized, controlled trial to estimate the effect size of financial incentives on achieving a patient-specific daily step goal in the hospital and post-discharge for 1 month following radical cystectomy. Secondary outcomes include step count, composite morbidity, and functional decline. Forty-six adults with bladder cancer undergoing radical cystectomy at the Hospital of the University of Pennsylvania will be randomized to either control (education of step goal with monitoring and daily feedback) or a gain financial incentive combined with a lottery incentive if they achieve 75% of the daily goals during the study period. Fitbit Zips will be used to measure step counts for all participants. This proposal will provide the preliminary data needed to design future, larger trials that will test the effect of financial incentives to increase ambulation on post operative complications, readmissions, and functional decline.
Read the detailed description
In this application, a randomized controlled trial will be used to test the hypothesis that small financial incentives can be used to increase post-operative ambulation. The randomized controlled trial design is necessary to demonstrate a causal relationship between the intervention (provision of financial incentives)and the outcome (increased ambulation). This design will also provide preliminary data (e.g. effect sizes, feasibility) needed to design larger trials that will determine whether increases in ambulation produced by financial incentives can be translated into decreases in clinically relevant outcomes such as post-operative complications, readmissions, and functional decline in patients undergoing major abdominal surgery.
All participants will receive education about the importance of early ambulation and knowledge of their daily step goals. A Fitbit Zip, a commercially available activity tracking device with the ability to record and wirelessly upload step counts, will be provided to each participant to measure the outcome of daily step counts for a lead in period of 1-2 weeks before surgery and 30 days after surgery with the option for patients to continue to submit data independently for up to 90 days after surgery. The lead-in period will provide data to determine a patient-specific daily step count baseline. Step count goals will change each week and be determined by a set-percentage of the patient-specific baseline. The percentages will be as follows: 10% of baseline for week 1, 25% of baseline for week 2, 40% of baseline for week 3, and 55% of baseline for week 4. Data will be collected using the Way To Health platform, a digital platform specifically designed to facilitate randomized controlled trials testing interventions increase health promoting behavior.
Participants will be randomized using simple balanced randomization into one of two arms: "control" or "financial incentives". Individuals will be informed if they fail to achieve adequate steps and would have otherwise been eligible for payments in order to leverage regret aversion. The financial incentive is framed as a "gain" rather than a "loss" because striving to achieve a positive reward may provide the necessary support to positively motivate patients who just had major, painful surgery. Small definite payments are combined with larger lottery-based payments to provide ongoing feedback coupled with the possibility of winning a higher magnitude reward. Automated notification about payments will be delivered through the participant's preferred mode of communication (e.g., phone call, email). Patients will track their earnings and step count over time through Way to Health.
Beginning shortly before the planned surgery and continuing for 30 days after date of surgery, all participants will use Fitbit Zips to measure daily step counts. Patients will have the option of submitting up to 90 days of post-operative data. Post-operative ambulation has been repeatedly demonstrated to be beneficial to recovery by a number of different metrics, and the Zip device has been shown to be an accurate measure of step counts. The Stanford Health Assessment Questionnaire (SHAQ) is a broadly used and validated questionnaire which, in its shortened form, assesses subjects ability to perform 20 different actions and the need for assistance with these actions. It also captures patients global assessments of pain and well-being. This will be administered preoperatively, 30 days post-operatively, and 90 days postoperatively to measured post-operative functional decline. The International Physical Activity Questionnaire (IPAQ) Short Seven Day form quantifies patient reported levels of physical activity over the seven days prior to the interview. It is similarly broadly used and has been previously validated against accelerometer data. This will be administered preoperatively, 30 days post-operatively, and 90 days postoperatively to measure post-operative decline in physical activity and to discover differences in baseline physical activity that are not captured by preoperative step-count data.The Multidimensional Scale of Perceived Social Support (MPPSS) is a validated tool for assessing patient's self-assessed degree of support from others. Prior research has suggested social support as an important factor in exercise behavior, which is consistent with our clinical observations. This will be administered pre-operatively and a 30 and 90 days post-operatively to help account for confounding by this important and otherwise unmeasured variable.
- Conditions
- Bladder Cancer
- Being tested
- Financial Incentive to Increase Ambulation
- Keywords
- Behavioral Economics, Financial Incentives, Bladder Cancer, Ambulation, Surgical Co-Morbidity, Fitbit, Mobile Health, Radical Cystectomy
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Financial Incentive to Increase AmbulationOther
Financial Incentive and possibility for financial lottery entry in addition to education on the benefits of post-surgery ambulation
| Study group | Role | What they receive |
|---|---|---|
| Financial Incentive | Experimental | Financial Incentive to Increase Ambulation: A financial reward is given on a per day basis when subject meets daily step goal, 1/5 chance to win additional monetary prize if patient uploads step count data for at least 75% of study days.
Subjects will use Fitbit Zip to track step counts Receives: Other: Financial Incentive to Increase Ambulation |
| Control (Education) | No intervention | Subjects in this group will receive standard education on the benefits of post-surgery ambulation only Subjects will use Fitbit Zips to track step counts |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Days Step Goal Completed
Number of days during the study period that each subject reaches their step goal
Measured: 30 days
Secondary outcomes (3)
Number of Steps Taken Per Day
Average number of steps taken per day in the 30 day postoperative period. Note that the average number of steps taken per day is calculated separately for each patient as simply (total number of steps taken in the 30 day postoperative period)/30. For the purposes of comparing the two study groups, nonparametric tests and medians are used. Thus the "measure type" listed in the "Outcome Measure Data Table" is correctly listed as "median". For example, in the Financial Incentive arm, we report a median average number of steps per day as 979, implying that half of the patients walked fewer than 979 steps on an average day and half of the patients walked more than 979 steps on an average day in that group.
Measured: 30 days
Composite Morbidity Outcome of Complications, Unplanned Readmissions, or Emergency Department Visits
Binary variable reflecting whether or not patient suffered any of the following: any postoperative complication, any unplanned readmission, any presentation to the emergency department within 30 days after surgery.
Measured: 30 days
Functional Decline as Assessed by the Stanford Health Assessment Questionnaire (SHAQ)
30-day postoperative Stanford Health Assessment Questionnaire Disability Index (SHAQ) score, indicating subjects ability to perform daily tasks.
Scores range continuously from 0-4 representing no disability to complete disability respectively. Scores >2 are usually considered severe disability.
The total score is computed as the mean of 8 categories: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Each category consists of a list of 2-3 actions. The participant selects whether they are able to perform each action "without any difficulty", "with some difficulty", "with much difficulty", or "unable to do". These selections are scored 0-4 respectively. The category is assigned the maximum score of its component actions. If the subject requires assistance from a person or device for an individual action, the minimum score for that action is 2.
Measured: 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionDec 2018
- Study completionFeb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (45)Papers the sponsor has linked to this study.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital of Philadelphia, National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Sponsor
- Investigators
- Gregory Tasian, MD,MSc,MSCE, Principal investigator, Children's Hospital of PhiladelphiaThomas Guzzo, MD, MPH, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02880176
- Sponsor's protocol ID
- 825215
- Other IDs
- UL1TR000003
- Acronym
- STEPP
- Status last verified
- Mar 2021
- First submitted
- 17 Aug 2016
- Last updated
- 9 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Stimson CJ, Chang SS, Barocas DA, Humphrey JE, Patel SG, Clark PE, Smith JA Jr, Cookson MS. Early and late perioperative outcomes following radical cystectomy: 90-day readmissions, morbidity and mortality in a contemporary series. J Urol. 2010 Oct;184(4):1296-300. doi: 10.1016/j.juro.2010.06.007. Epub 2010 Aug 17.
PubMed 20723939Gandaglia G, Varda B, Sood A, Pucheril D, Konijeti R, Sammon JD, Sukumar S, Menon M, Sun M, Chang SL, Montorsi F, Kibel AS, Trinh QD. Short-term perioperative outcomes of patients treated with radical cystectomy for bladder cancer included in the National Surgical Quality Improvement Program (NSQIP) database. Can Urol Assoc J. 2014 Sep;8(9-10):E681-7. doi: 10.5489/cuaj.2069.
PubMed 25408807Tan HJ, Kaplan AL, Chuang RJ, Kwan L, Filson CP, Litwin MS. The Cost Burden of Complications after Major Surgery for Urological Cancer: Opportunities for Value Creation in Urology. Urol Pract. 2016 Mar;3(2):81-89. doi: 10.1016/j.urpr.2015.05.002. Epub 2015 Dec 29.
PubMed 37592482Pashikanti L, Von Ah D. Impact of early mobilization protocol on the medical-surgical inpatient population: an integrated review of literature. Clin Nurse Spec. 2012 Mar-Apr;26(2):87-94. doi: 10.1097/NUR.0b013e31824590e6.
PubMed 22336934Raue W, Haase O, Junghans T, Scharfenberg M, Muller JM, Schwenk W. 'Fast-track' multimodal rehabilitation program improves outcome after laparoscopic sigmoidectomy: a controlled prospective evaluation. Surg Endosc. 2004 Oct;18(10):1463-8. doi: 10.1007/s00464-003-9238-y. Epub 2004 Aug 26.
PubMed 15791370Padula CA, Hughes C, Baumhover L. Impact of a nurse-driven mobility protocol on functional decline in hospitalized older adults. J Nurs Care Qual. 2009 Oct-Dec;24(4):325-31. doi: 10.1097/NCQ.0b013e3181a4f79b.
PubMed 19395979Baird G, Maxson P, Wrobleski D, Luna BS. Fast-track colorectal surgery program reduces hospital length of stay. Clin Nurse Spec. 2010 Jul-Aug;24(4):202-8. doi: 10.1097/NUR.0b013e3181e3604c.
PubMed 20526121Gustafsson UO, Hausel J, Thorell A, Ljungqvist O, Soop M, Nygren J; Enhanced Recovery After Surgery Study Group. Adherence to the enhanced recovery after surgery protocol and outcomes after colorectal cancer surgery. Arch Surg. 2011 May;146(5):571-7. doi: 10.1001/archsurg.2010.309. Epub 2011 Jan 17.
PubMed 21242424Lee TG, Kang SB, Kim DW, Hong S, Heo SC, Park KJ. Comparison of early mobilization and diet rehabilitation program with conventional care after laparoscopic colon surgery: a prospective randomized controlled trial. Dis Colon Rectum. 2011 Jan;54(1):21-8. doi: 10.1007/DCR.0b013e3181fcdb3e.
PubMed 21160309Kibler VA, Hayes RM, Johnson DE, Anderson LW, Just SL, Wells NL. Cultivating quality: early postoperative ambulation: back to basics. Am J Nurs. 2012 Apr;112(4):63-9. doi: 10.1097/01.NAJ.0000413460.45487.ea. No abstract available.
PubMed 22456575Loewenstein G, Brennan T, Volpp KG. Asymmetric paternalism to improve health behaviors. JAMA. 2007 Nov 28;298(20):2415-7. doi: 10.1001/jama.298.20.2415. No abstract available.
PubMed 18042920Haisley E, Volpp KG, Pellathy T, Loewenstein G. The impact of alternative incentive schemes on completion of health risk assessments. Am J Health Promot. 2012 Jan-Feb;26(3):184-8. doi: 10.4278/ajhp.100729-ARB-257.
PubMed 22208418Strully KW, Fowler JH, Murabito JM, Benjamin EJ, Levy D, Christakis NA. Aspirin use and cardiovascular events in social networks. Soc Sci Med. 2012 Apr;74(7):1125-9. doi: 10.1016/j.socscimed.2011.12.033. Epub 2012 Feb 4.
PubMed 22361089Christakis NA, Fowler JH. The spread of obesity in a large social network over 32 years. N Engl J Med. 2007 Jul 26;357(4):370-9. doi: 10.1056/NEJMsa066082. Epub 2007 Jul 25.
PubMed 17652652Thaler R, Sunstein C. Nudge: improving decisions about health, wealth and happiness. New Haven, CT: Yale University Press; 2008.
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Steps to Eliminate Postoperative Problems
- ClinicalTrials.gov ID
- NCT02880176
- Acronym / sponsor ID
- STEPP / 825215
- Conditions
- Bladder Cancer
- Keywords
- Behavioral Economics, Financial Incentives, Bladder Cancer, Ambulation, Surgical Co-Morbidity, Fitbit, Mobile Health, Radical Cystectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Children's Hospital of Philadelphia, National Center for Advancing Translational Sciences (NCATS)
- Study start
- Aug 2016
- Primary completion
- Dec 2018 (actual)
- Study completion
- Feb 2019 (actual)
- First posted
- 26 Aug 2016 (estimated)
- Results
- Posted 9 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Radical cystectomy with urinary diversion is associated with substantial perioperative morbidity, including deep venous thrombosis, prolonged ileus, and postoperative functional decline. Post-operative morbidity after cystectomy prolongs the length of stay, increases the risk of readmission, and adds substantially to health care costs. Protocols that emphasize early and frequent ambulation after surgery decreases post-operative morbidity, but poor patient adherence diminishes the effectiveness of these protocols, which are currently implemented only during the hospital stay. Financial incentives overcome present bias and offer a novel and practical approach to increasing ambulation during the post-operative period in the hospital and also after discharge. This application proposes a pilot randomized, controlled trial to estimate the effect size of financial incentives on achieving a patient-specific daily step goal in the hospital and post-discharge for 1 month following radical cystectomy. Secondary outcomes include step count, composite morbidity, and functional decline. Forty-six adults with bladder cancer undergoing radical cystectomy at the Hospital of the University of Pennsylvania will be randomized to either control (education of step goal with monitoring and daily feedback) or a gain financial incentive combined with a lottery incentive if they achieve 75% of the daily goals during the study period. Fitbit Zips will be used to measure step counts for all participants. This proposal will provide the preliminary data needed to design future, larger trials that will test the effect of financial incentives to increase ambulation on post operative complications, readmissions, and functional decline.
Detailed description
In this application, a randomized controlled trial will be used to test the hypothesis that small financial incentives can be used to increase post-operative ambulation. The randomized controlled trial design is necessary to demonstrate a causal relationship between the intervention (provision of financial incentives)and the outcome (increased ambulation). This design will also provide preliminary data (e.g. effect sizes, feasibility) needed to design larger trials that will determine whether increases in ambulation produced by financial incentives can be translated into decreases in clinically relevant outcomes such as post-operative complications, readmissions, and functional decline in patients undergoing major abdominal surgery.
All participants will receive education about the importance of early ambulation and knowledge of their daily step goals. A Fitbit Zip, a commercially available activity tracking device with the ability to record and wirelessly upload step counts, will be provided to each participant to measure the outcome of daily step counts for a lead in period of 1-2 weeks before surgery and 30 days after surgery with the option for patients to continue to submit data independently for up to 90 days after surgery. The lead-in period will provide data to determine a patient-specific daily step count baseline. Step count goals will change each week and be determined by a set-percentage of the patient-specific baseline. The percentages will be as follows: 10% of baseline for week 1, 25% of baseline for week 2, 40% of baseline for week 3, and 55% of baseline for week 4. Data will be collected using the Way To Health platform, a digital platform specifically designed to facilitate randomized controlled trials testing interventions increase health promoting behavior.
Participants will be randomized using simple balanced randomization into one of two arms: "control" or "financial incentives". Individuals will be informed if they fail to achieve adequate steps and would have otherwise been eligible for payments in order to leverage regret aversion. The financial incentive is framed as a "gain" rather than a "loss" because striving to achieve a positive reward may provide the necessary support to positively motivate patients who just had major, painful surgery. Small definite payments are combined with larger lottery-based payments to provide ongoing feedback coupled with the possibility of winning a higher magnitude reward. Automated notification about payments will be delivered through the participant's preferred mode of communication (e.g., phone call, email). Patients will track their earnings and step count over time through Way to Health.
Beginning shortly before the planned surgery and continuing for 30 days after date of surgery, all participants will use Fitbit Zips to measure daily step counts. Patients will have the option of submitting up to 90 days of post-operative data. Post-operative ambulation has been repeatedly demonstrated to be beneficial to recovery by a number of different metrics, and the Zip device has been shown to be an accurate measure of step counts. The Stanford Health Assessment Questionnaire (SHAQ) is a broadly used and validated questionnaire which, in its shortened form, assesses subjects ability to perform 20 different actions and the need for assistance with these actions. It also captures patients global assessments of pain and well-being. This will be administered preoperatively, 30 days post-operatively, and 90 days postoperatively to measured post-operative functional decline. The International Physical Activity Questionnaire (IPAQ) Short Seven Day form quantifies patient reported levels of physical activity over the seven days prior to the interview. It is similarly broadly used and has been previously validated against accelerometer data. This will be administered preoperatively, 30 days post-operatively, and 90 days postoperatively to measure post-operative decline in physical activity and to discover differences in baseline physical activity that are not captured by preoperative step-count data.The Multidimensional Scale of Perceived Social Support (MPPSS) is a validated tool for assessing patient's self-assessed degree of support from others. Prior research has suggested social support as an important factor in exercise behavior, which is consistent with our clinical observations. This will be administered pre-operatively and a 30 and 90 days post-operatively to help account for confounding by this important and otherwise unmeasured variable.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Financial Incentive | Experimental | Other: Financial Incentive to Increase AmbulationFinancial Incentive to Increase Ambulation: A financial reward is given on a per day basis when subject meets daily step goal, 1/5 chance to win additional monetary prize if patient uploads step count data for at least 75% of study days. Subjects will use Fitbit Zip to track step counts |
| Control (Education) | No intervention | –Subjects in this group will receive standard education on the benefits of post-surgery ambulation only Subjects will use Fitbit Zips to track step counts |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Planning to undergo radical cystectomy (either with ileal conduit, Indiana pouch, neobladder (e.g., Studer or Hautmann pouch) at the University of Pennsylvania
- Patient has been diagnosed with bladder cancer
- Patient is at least 21 years of age
- Patient is ambulatory with baseline ECOG performance status less than or equal to 2
Key exclusion criteria (7 listed)
- Patient knows he or she will be unable or unwilling to use a mobile device and online tool to upload activity data
- Poor preoperative performance status (ECOG 3 or greater)
- Plan for cystectomy without cutaneous ureterostomies (without a bowel diversion)
- Non-English speakers
- Patient is non-ambulatory
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Financial Incentive to Increase AmbulationFinancial Incentive and possibility for financial lottery entry in addition to education on the benefits of post-surgery ambulation | Other | Financial Incentive |
Primary outcome
Number of Days Step Goal Completed
Time frame: 30 days
Number of days during the study period that each subject reaches their step goal
3 secondary outcomes
Number of Steps Taken Per Day
Time frame: 30 days
Composite Morbidity Outcome of Complications, Unplanned Readmissions, or Emergency Department Visits
Time frame: 30 days
Functional Decline as Assessed by the Stanford Health Assessment Questionnaire (SHAQ)
Time frame: 1 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20723939Stimson CJ, Chang SS, Barocas DA, Humphrey JE, Patel SG, Clark PE, Smith JA Jr, Cookson MS. Early and late perioperative outcomes following radical cystectomy: 90-day readmissions, morbidity and mortality in a contemporary series. J Urol. 2010 Oct;184(4):1296-300. doi: 10.1016/j.juro.2010.06.007. Epub 2010 Aug 17.
- Background: PubMed 25408807Gandaglia G, Varda B, Sood A, Pucheril D, Konijeti R, Sammon JD, Sukumar S, Menon M, Sun M, Chang SL, Montorsi F, Kibel AS, Trinh QD. Short-term perioperative outcomes of patients treated with radical cystectomy for bladder cancer included in the National Surgical Quality Improvement Program (NSQIP) database. Can Urol Assoc J. 2014 Sep;8(9-10):E681-7. doi: 10.5489/cuaj.2069.
- Background: PubMed 37592482Tan HJ, Kaplan AL, Chuang RJ, Kwan L, Filson CP, Litwin MS. The Cost Burden of Complications after Major Surgery for Urological Cancer: Opportunities for Value Creation in Urology. Urol Pract. 2016 Mar;3(2):81-89. doi: 10.1016/j.urpr.2015.05.002. Epub 2015 Dec 29.
- Background: PubMed 22336934Pashikanti L, Von Ah D. Impact of early mobilization protocol on the medical-surgical inpatient population: an integrated review of literature. Clin Nurse Spec. 2012 Mar-Apr;26(2):87-94. doi: 10.1097/NUR.0b013e31824590e6.
- Background: PubMed 15791370Raue W, Haase O, Junghans T, Scharfenberg M, Muller JM, Schwenk W. 'Fast-track' multimodal rehabilitation program improves outcome after laparoscopic sigmoidectomy: a controlled prospective evaluation. Surg Endosc. 2004 Oct;18(10):1463-8. doi: 10.1007/s00464-003-9238-y. Epub 2004 Aug 26.
- Background: PubMed 19395979Padula CA, Hughes C, Baumhover L. Impact of a nurse-driven mobility protocol on functional decline in hospitalized older adults. J Nurs Care Qual. 2009 Oct-Dec;24(4):325-31. doi: 10.1097/NCQ.0b013e3181a4f79b.
- Background: PubMed 20526121Baird G, Maxson P, Wrobleski D, Luna BS. Fast-track colorectal surgery program reduces hospital length of stay. Clin Nurse Spec. 2010 Jul-Aug;24(4):202-8. doi: 10.1097/NUR.0b013e3181e3604c.
- Background: PubMed 21242424Gustafsson UO, Hausel J, Thorell A, Ljungqvist O, Soop M, Nygren J; Enhanced Recovery After Surgery Study Group. Adherence to the enhanced recovery after surgery protocol and outcomes after colorectal cancer surgery. Arch Surg. 2011 May;146(5):571-7. doi: 10.1001/archsurg.2010.309. Epub 2011 Jan 17.
- Background: PubMed 21160309Lee TG, Kang SB, Kim DW, Hong S, Heo SC, Park KJ. Comparison of early mobilization and diet rehabilitation program with conventional care after laparoscopic colon surgery: a prospective randomized controlled trial. Dis Colon Rectum. 2011 Jan;54(1):21-8. doi: 10.1007/DCR.0b013e3181fcdb3e.
- Background: PubMed 22456575Kibler VA, Hayes RM, Johnson DE, Anderson LW, Just SL, Wells NL. Cultivating quality: early postoperative ambulation: back to basics. Am J Nurs. 2012 Apr;112(4):63-9. doi: 10.1097/01.NAJ.0000413460.45487.ea. No abstract available.
- Background: PubMed 18042920Loewenstein G, Brennan T, Volpp KG. Asymmetric paternalism to improve health behaviors. JAMA. 2007 Nov 28;298(20):2415-7. doi: 10.1001/jama.298.20.2415. No abstract available.
- Background: PubMed 22208418Haisley E, Volpp KG, Pellathy T, Loewenstein G. The impact of alternative incentive schemes on completion of health risk assessments. Am J Health Promot. 2012 Jan-Feb;26(3):184-8. doi: 10.4278/ajhp.100729-ARB-257.
- Individual participant dataSharing planned: No
Related trials for Bladder Cancer
RecruitingObservational study
Evaluation for NCI Surgery Branch Clinical Research Protocols
Synovial Cell Cancer, Melanoma
RecruitingObservational study
Collection of Serum and Tissue Samples From Patients With Biopsy-Proved or Suspected Malignant Disease
Malignant Neoplasms, Hereditary Neoplastic Syndromes
Active, not recruitingPhase 2
Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
Active, not recruitingPhase 1/2
A Phase II Study of Atezolizumab in Combination With Cisplatin + Gemcitabine Before Surgery to Remove the Bladder Cancer
Bladder Cancer, Metastatic Bladder Cancer
Active, not recruitingPhase 3
Testing MK-3475 (Pembrolizumab) After Surgery for Localized Muscle-Invasive Bladder Cancer and Locally Advanced Urothelial Cancer
Localized Renal Pelvis and Ureter Urothelial Carcinoma, Locally Advanced Bladder Urothelial Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory Tasian, MD,MSc,MSCE principal investigator
Children's Hospital of Philadelphia
Thomas Guzzo, MD, MPH principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Financial Incentive to Increase Ambulation in people with Bladder Cancer, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Days Step Goal Completed (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02880176, which also lists 45 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2021; AzTrials last refreshed its copy on 27 Oct 2026.