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Bladder CancerCaReNCT07180121

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

An observational study of Bladder Cancer, run by Linkoeping University at 1 site in Sweden.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Bladder Cancer
How many people
200 participants
Where
1 siteSweden
Study dates
19 Sep 2024to 31 Dec 2027
Phase
Observational
Are there results?
Not yet: the study is under way

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 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • Patients >18 years
  • Diagnosis bladder cancer
  • Cystectomy

Who cannot join

  • Cognitive impairment screened using the screening tool 4AT.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Sweden1 site
  • Department of Urology

    Linköping, 581 83

Other trials in Sweden

About this study

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.

Read more

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.

Conditions
Bladder Cancer
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.

Study groups in NCT07180121
Study groupRoleWhat they receive
Bladder cancer undergoing radical cystectomy.Bladder cancer undergoing radical cystectomy.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Information needs

    EORTC QLQ-INFO25

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Sep 2025
  2. Study start19 Sep 2024
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07180121
Sponsor's protocol ID
CaRe
Acronym
CaRe
Status last verified
Aug 2026
First submitted
25 May 2025
Last updated
26 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Bladder Cancer, run by Linkoeping University at 1 site in Sweden.

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 3 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 26 Aug 2026. 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 Sweden. 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?

This study is still under way. Results are not available in the source record yet.

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?

Information needs (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 26 Aug 2026.

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