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Enrolling by invitationNCT07180121CaReUpdated Aug 26, 2026

Information Needs and Supportive Rehabilitation Over Time in Patients Undergoing Cystectomy in Bladder Cancer

An observational study in Bladder Cancer, sponsored by Linkoeping University. Enrolling by invitation at 1 site in Sweden. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-08-26.

Sponsored by Linkoeping University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years to 100 Years
Sex
All
01

Study summary

Bladder cancer is one of the diseases that can affect the urinary tract. Globally, it is the tenth most common cancer, with an incidence rate of 9.5 per 100,000 persons per year for men and 2.4 for women. In Sweden, approximately 3,200 patients are diagnosed annually. It predominantly affects the elderly population over 70 years old. Men are more frequently affected, and bladder cancer is now the fourth most common cancer among men in Sweden.

Radical cystectomy is the gold standard treatment for non-metastatic muscle-invasive bladder cancer. The operation involves the removal of the bladder. Most patients are treated with chemotherapy beforehand. A new urinary diversion is created using the small intestine, with the ileal conduit being the most common type. The ureters are connected to the segment of the small intestine, which is then brought out as a stoma on the abdominal wall. Urine will now be collected in a stoma bag. The operation is extensive and can be performed using open or robot-assisted laparoscopic techniques. The average hospital stay for patients undergoing surgery in Sweden is approximately fifteen days.

For patients undergoing cystectomy, their future life is affected by both external and internal physical changes that they need to adapt to. The external physical change with a stoma alters their body appearance, and self-care needs to be performed for the rest of their lives. Self-care, symptoms, and complications can limit patients in their daily lives and negatively impact their social life. The internal physical change affects the internal genital organs and can impact sexual function. This can limit patients' sexual and intimate life.

Receiving a cancer diagnosis is overwhelming. From this moment, a process begins for each individual that involves receiving and absorbing information about the disease and surgery, treatment, and future life. Patients generally have difficulty remembering and absorbing information given during healthcare visits. A cancer diagnosis creates anxiety and is frightening, further impacting what patients remember afterward. Information needs arise when there is a gap between the available information and knowledge compared to what is needed. The patient group feels that their information needs are not met by healthcare personnel during the process from diagnosis to surgery and the immediate time afterward.

Self-care is defined as a process to maintain and uphold health through health-promoting activities and strategies to manage illness. It is a fundamental part of patients' treatment and affects the conditions for adapting to their new everyday life and promotes independent living. Well-functioning self-care contributes to higher health-related quality of life, faster recovery after surgery, reduced risk of complications, less utilization of hospital care leading to reduced healthcare costs, and longer survival. Self-care is an umbrella term that includes self-monitoring and self-management. Self-monitoring involves independently monitoring, interpreting, and assessing whether symptoms require action or contact with healthcare personnel. Self-management is necessary for recovery to manage health problems with troublesome symptoms that arise.

Self-efficacy involves confidence in one's own ability and is significant for adherence to self-care. Empowerment focuses on the ability and responsibility for choices to achieve one's goals and gain control over one's own life. Health literacy is linked to literacy and encompasses a person's knowledge, motivation, and competence to access, understand, assess, and make decisions based on health-related information. Together, these concepts contribute to patients' ability to adapt to their cancer diagnosis and improve their ability to manage treatment-related behavioral changes.

Needs arising from illness and treatment vary over time. They can arise before, during, and sometimes long after the treatment. Continuous, structured mapping of problem areas facilitates the identification of individualized interventions. Cancer rehabilitation promotes health and quality of life and is fundamental to preventing disability, maintaining or regaining previous physical abilities. The level of intervention and education depends on the extent and complexity of the needs and must consider health literacy.

Scientific Purpose of the Project

To explore information needs, health, and supportive rehabilitation in patients with bladder cancer undergoing radical cystectomy.

Read the detailed description

Specific Objectives

To investigate experiences of information needs in patients with bladder cancer who have undergone cystectomy.

To explore experiences and needs for supportive rehabilitation over time in patients undergoing cystectomy for bladder cancer.

To identify and evaluate patients' information needs, graded health, health literacy, and self-efficacy over time in patients undergoing cystectomy for bladder cancer.

02

Conditions studied

  • Bladder Cancer
03

In context

Urinary Bladder Neoplasms

1,798 studies on the registry are indexed under Urinary Bladder Neoplasms; 445 are open to participants now.

This study's planned enrollment of 200 is close to the median of 200 across 410 observational studies indexed under Urinary Bladder Neoplasms.

Browse Urinary Bladder Neoplasms studies →

Lead sponsor

Linkoeping University is the lead sponsor of 193 studies on the registry; 40 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients >18 years who have undergone cystectomy for bladder cancer.

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.

Inclusion criteria

  • Patients >18 years
  • Diagnosis bladder cancer
  • Cystectomy

Exclusion criteria

Exclusion criteria:

- Cognitive impairment screened using the screening tool 4AT.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No

Groups and cohorts

  • Bladder cancer undergoing radical cystectomy.

    Bladder cancer undergoing radical cystectomy.

06

What researchers measure

Primary outcomes

  1. Information needs

    EORTC QLQ-INFO25

    Time frame: 1 year

Other outcomes

  1. Screening symptoms and health

    longitudinal measurements of symptoms and health, questionnarie in line with "my care plan cancer"

    Time frame: 1 year

  2. health litteracy

    Validated instrument; s-fhl and s-chl

    Time frame: baseliine

  3. Self efficacy

    The General Self-Efficacy Scale (GSE)

    Time frame: baseline

07

Study locations

1 site
  • Department of Urology
    Linköping, 581 83, Sweden
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2024 (actual). Primary completion is estimated for Dec 2026, 27 months after the start.

Of 167 non-industry observational studies under Urinary Bladder Neoplasms, half reached primary completion within 60 months of starting (the median), counting those still running; a quarter within 30. This study's planned 27 months is below that.

Counting every sponsor, half of 202 studies reached it within 60 months; a quarter within 32.

How these figures are worked out, and which studies are left out of them.

Registered
May 25, 2025
First posted
Sep 18, 2025
StartActual
Sep 19, 2024
Primary completionEst.
Dec 31, 2026
CompletionEst.
Dec 31, 2027
Last update
Aug 26, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 26, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07180121
Collaborators
Region Östergötland
Responsible party
Jenny Drott (Associate Professor, Linkoeping University) — Principal investigator
First posted
Sep 18, 2025
Start date
Sep 19, 2024
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Aug 26, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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