Physical Activity, Kinesiophobia, and Stoma Compliance in Urostomy Patients

NCT06541821 | Enrolling By Invitation

• 1 other identifier: 2024/07.25
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bladder Cancer

Outcome Measures

Primary Outcomes (3)

• International Physical Activity Questionnaire Short Form (IPAQ-SF)

  To assess physical activity levels in METs

  10 minutes

• Tampa Kinesiophobia Scale

  assess fear of movement in patients

  10 minutes

• Ostomy Compliance Scale

  Determination of psychosocial adaptation levels of individuals with ostomy to ostomy

  10 minutes

Study Arms (2)

Urostomy Patients Group

Other: survey evaluation

Control Group

Other: survey evaluation

Interventions

survey evaluation OTHER

assessment of physical activity, fear of movement, and ostomy compliance

Control Group; Urostomy Patients Group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients using ostomy after Urostomy Surgeries for Bladder Cancer

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Selcuk University: lead

Study Sites (1)

Selcuk University

Konya, Selçuklu, 42130, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Prof. Dr.

Study Record Dates

• First Submitted: August 2, 2024
• First Posted: August 7, 2024
• Study Start: August 2, 2024
• Primary Completion: August 30, 2024
• Study Completion: September 15, 2024
• Last Updated: August 7, 2024

Record last verified: 2024-08

Locations

TU (1)