Bladder CancerNCT06541821
Physical Activity, Kinesiophobia, and Stoma Compliance in Urostomy Patients
An observational study of Bladder Cancer, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
In this study, it is aimed to determine the level of physical activity, to investigate kinesiophobia, to determine compliance with the stoma and to compare with healthy controls in patients with bladder cancer who have undergone urostomy surgery and live with a stoma. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- survey evaluation
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Aug 2024to 15 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients using ostomy after Urostomy Surgeries for Bladder Cancer
Who may be able to join
- The patient group will include people between the ages of 40-75 who underwent urostomy surgery and a stoma after being diagnosed with bladder cancer.
- The control group will include age-matched healthy people with similar age, body weight and height, without a previous history of cancer.
Who cannot join
- Orthotopic surgeries will not be included in the patient group
- Being under the age of 40,
- Being diagnosed with lymphedema,
- Presence of active metastasis,
- Neurological pathologies that limit voluntary mobility,
- Orthopedic and cardiovascular pathologies,
- Having a learning disability or other cognitive or communication impairment.
- The control group will be excluded if they have any history of cancer.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of Physical Activity, Kinesiophobia, and Stoma Compliance in Patients Undergoing Urostomy for Bladder Cancer
In this study, it is aimed to determine the level of physical activity, to investigate kinesiophobia, to determine compliance with the stoma and to compare with healthy controls in patients with bladder cancer who have undergone urostomy surgery and live with a stoma.
- Conditions
- Bladder Cancer
- Being tested
- survey evaluation
- 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.
survey evaluationOther
assessment of physical activity, fear of movement, and ostomy compliance
| Study group | Role | What they receive |
|---|---|---|
| Urostomy Patients Group | Not described Receives: Other: survey evaluation | |
| Control Group | Not described Receives: Other: survey evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Physical Activity Questionnaire Short Form (IPAQ-SF)
To assess physical activity levels in METs
Measured: 10 minutes
Tampa Kinesiophobia Scale
assess fear of movement in patients
Measured: 10 minutes
Ostomy Compliance Scale
Determination of psychosocial adaptation levels of individuals with ostomy to ostomy
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start2 Aug 2024 (estimated)
- Primary completion30 Aug 2024 (estimated)
- Study completion15 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by Selcuk UniversityThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emine Cihan, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06541821
- Sponsor's protocol ID
- 2024/07.25
- Status last verified
- Aug 2024
- First submitted
- 2 Aug 2024
- Last updated
- 7 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Physical Activity, Kinesiophobia, and Stoma Compliance in Patients Undergoing Urostomy for Bladder Cancer
- ClinicalTrials.gov ID
- NCT06541821
- Acronym / sponsor ID
- 2024/07.25
- Conditions
- Bladder Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 2 Aug 2024 (estimated)
- Primary completion
- 30 Aug 2024 (estimated)
- Study completion
- 15 Sep 2024 (estimated)
- First posted
- 7 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, it is aimed to determine the level of physical activity, to investigate kinesiophobia, to determine compliance with the stoma and to compare with healthy controls in patients with bladder cancer who have undergone urostomy surgery and live with a stoma.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Urostomy Patients Group | – | Other: survey evaluation |
| Control Group | – | Other: survey evaluation |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients using ostomy after Urostomy Surgeries for Bladder Cancer
Key inclusion criteria (2 listed)
- The patient group will include people between the ages of 40-75 who underwent urostomy surgery and a stoma after being diagnosed with bladder cancer.
- The control group will include age-matched healthy people with similar age, body weight and height, without a previous history of cancer.
Key exclusion criteria (8 listed)
- Orthotopic surgeries will not be included in the patient group
- Being under the age of 40,
- Being diagnosed with lymphedema,
- Presence of active metastasis,
- Neurological pathologies that limit voluntary mobility,
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 |
|---|---|---|
| survey evaluationassessment of physical activity, fear of movement, and ostomy compliance | Other | Control Group, Urostomy Patients Group |
Primary outcome
International Physical Activity Questionnaire Short Form (IPAQ-SF)
Time frame: 10 minutes
To assess physical activity levels in METs
Tampa Kinesiophobia Scale
Time frame: 10 minutes
assess fear of movement in patients
Ostomy Compliance Scale
Time frame: 10 minutes
Determination of psychosocial adaptation levels of individuals with ostomy to ostomy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Cancer, run by Selcuk University at 1 site in Turkey (Türkiye).
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 2 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 7 Aug 2024. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
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?
International Physical Activity Questionnaire Short Form (IPAQ-SF) (time frame: 10 minutes). The study lists 3 primary outcomes in all. 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 7 Aug 2024.