An interventional study of Daily Activity Goal and Feedback in Bladder Cancer, Bladder Neoplasm and Bladder Urothelial Carcinoma, sponsored by Universitätsmedizin Mannheim. Recruiting at 2 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-16.
Sponsored by Universitätsmedizin Mannheim · Not applicable, Interventional, and Treatment
A bicentric, open-label randomised controlled trial (RCT) is planned to investigate whether the use of fitness wristbands in a defined preoperative period prior to radical cystectomy leads to a preoperative increase in participants' physical activity (number of steps per day) up to the day of radical cystectomy.
The goal of the PreAct study is to test whether the use of fitness wristbands in a defined preoperative period prior to radical cystectomy with a daily activity goal and feedback on the achievement of this goal improves the participants' physical activity up to the day of radical cystectomy.
In addition to the fitness tracker, we provide each patient with a smartphone. For each fitness tracker a separate account in a fitness application is set up for (e.g. name: tracker1.0 with the corresponding e-mail address and password). Neither the patients in the Daily activity Goal and Feedback arm nor the No Daily Activity Goal or Feedback arm receive the access data to the accounts. However, the patients in the intervention group receive the access PIN for the smartphone. On this smartphone a messaging service and the fitness application are installed. The patient thus receives, for example the wristband tracker1.0, which is registered with the corresponding access data in the fitness application of the smartphone given to them. For the entire preoperative period, the Bluetooth function on the smartphone must always stay activated so that the fitness application and the fitness tracker are continuously connected to each other. A detailed description of the timing and implementation of the intervention are described in "Study design" and "Arm and Interventions".
1,798 studies on the registry are indexed under Urinary Bladder Neoplasms; 445 are open to participants now.
This study's planned enrollment of 164 is above the median of 60 across 1,296 interventional studies indexed under Urinary Bladder Neoplasms.
Browse Urinary Bladder Neoplasms studies →Universitätsmedizin Mannheim is the lead sponsor of 78 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The participants in the Daily Activity Goal and Feedback arm receive a defined daily activity goal in the form of a defined number of steps, feedback on the achievement of this goal, and push-up notifications sent directly to the wristband to encourage them to remain active.
Device: Daily Activity Goal and Feedback
The display of the fitness wristbands of the No Daily Activity Goal or Feedback arm is covered up. The participants in this arm neither receive a daily activity goal nor get feedback on the achievement of the activity goal/push-up notifications.
The daily activity target is a fixed number of steps. The exact number of steps is determined beforehand as part of the case number planning in a pilot study with ten participants and adjusted if necessary. The activity target we suggest is 8000 steps. In addition, the participants receive feedback several times a day about the steps needed to reach the goal and whether they have ultimately reached the daily goal.
Number of steps per day
Average daily step count measured by the fitness tracker during the period of prehabilitation 7 to 10 days before surgery.
Time frame: Participants' daily step count is recorded on the day of surgery when the fitness tracker is put down.
Total number of steps
Total number of steps measured by the fitness tracker during the period of prehabilitation 7 to 10 days before surgery.
Time frame: Participants' total number of steps is recorded on the day of surgery when the fitness tracker is put down.
Postoperative physical activity
The postoperative physical activity of the participants measured by the average number of steps per day and in total on postoperative days 1 to 3. Neither arm will receive a daily activity goal. However, the fitness trackers of the No Daily Activity Goal or Feedback arm are still covered.
Time frame: Morning of postoperative day 4 at 7 PM
Postoperative Complications
Postoperative complications measured by the Comprehensive Classification Index (CCI), on a scale from 0 (no complications) to 100 (death), (Slankamenac, Graf et al. 2013) and the Clavien-Dindo Classification (CDC), which consists of 7 grades (I, II, IIIa, IIIb, IVa, IVb and V), the first one indicating any deviation from the normal postoperative course, the highest grade indicating death (Clavien, Barkun et al. 2009): CDC ≥ 3a corresponding to a CCI ≥ 26.2 defined as "severe complications" including CDC = 5 and CCI = 100 defined as "patient's death" and the total number of complications
Time frame: On postoperative day 30 and 90
Operating time
In minutes, incision - surgical incision closure
Time frame: On the day of surgery
Blod loss
In millilitres
Time frame: On the day of surgery
Required transfusion of blood products
Number of red blood cell concentrates, platelet concentrates, frozen fresh plasma
Time frame: On the day of surgery
Feasibility of the planned urinary diversion
Yes or no
Time frame: On the day of surgery
Conversion rate
If the planned urinary diversion is not feasible
Time frame: On the day of surgery
Patient Reported Outcome Measures (PROMs)
SF-36: Health-related quality of life (Scale 0 - 100: The higher the score, the lower the disability. A score of 100 corresponds to no disability)
Time frame: On the day of randomization at the premedication appointment and on the day of discharge which is on average 2 weeks after the surgery and postoperative day 30 and 90
Length of hospital stay (LOS)
LOS measured by the number of days spent in the hospital after surgery until discharge
Time frame: On the day of discharge which is on average 2 weeks after the surgery
Readmission rate
Readmissions due to a complication of the radical cystectomy
Time frame: On postoperative day 90 if occured
Reoperation rate
Reoperation due to a complication of the radical cystectomy
Time frame: On postoperative day 90 if occured
Length of stay in the intensive care unit (ICU)
Days spent in the ICU after surgery
Time frame: On postoperative day 90 if occured
Started Mar 2023 (actual). Primary completion is estimated for Mar 2025, 24 months after the start.
Of 235 non-industry interventional studies with no phase under Urinary Bladder Neoplasms, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 70. This study's planned 24 months is below that.
Counting every sponsor, half of 244 studies reached it within 39 months; a quarter within 20 and three quarters within 69.
How these figures are worked out, and which studies are left out of them.
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