Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06350734
Other study ID # 18-004675
Secondary ID NCI-2024-0097318
Status Recruiting
Phase
First received
Last updated
Start date October 12, 2018
Est. completion date January 31, 2029

Study information

Verified date April 2024
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study evaluates the effect of bladder cancer treatment on quality of life.


Description:

PRIMARY OBJECTIVES: I. To compare general and disease-specific quality of life outcomes at 6, 12, 24, and 36 months after treatment for localized bladder cancer using the PROMIS-29 and the Bladder Cancer Index (BCI) respectively. II. To identify patient level characteristics that may influence quality of life outcomes after treatment for localized bladder cancer. OUTLINE: This is an observational study. Patients complete surveys and also have their medical records reviewed on study.


Recruitment information / eligibility

Status Recruiting
Enrollment 704
Est. completion date January 31, 2029
Est. primary completion date January 31, 2029
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Have pathologically confirmed, clinically localized, bladder cancer - Be willing to complete a survey in English before starting definitive treatment (surgery or radiation); - Able to give consent. Exclusion Criteria: - Does not meet inclusion criteria

Study Design


Intervention

Other:
Non-Interventional Study
Non-Interventional Study

Locations

Country Name City State
United States Mayo Clinic in Florida Jacksonville Florida
United States Mayo Clinic in Rochester Rochester Minnesota
United States Mayo Clinic in Arizona Scottsdale Arizona

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in quality of life outcomes - PROMIS-29 Assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS)-29, a 29-item instrument with 29 questions in eight categories of Health Related Quality of Life (HRQOL): physical function, sleep disturbance, pain interference and pain intensity, fatigue, anxiety, depression) and ability to participate in social roles and activities. Questions are answered on a 5-point scale with varying responses assigned to the scale based on the category/question. At baseline, 6, 12, 24, and 36 months
Primary Change in quality of life outcomes - Bladder Cancer Index Assessed using the Bladder Cancer Index (BCI). The BCI consists of 36 items, with 4- or 5-point Likert response scales for each item, covering 3 primary domains: urinary (14 items), bowel (10 items), and sexual (12 items). The items focus on the frequency of the disease symptoms, with answer scales such as: "Never, rarely, about half the time, usually, or always". At baseline, 6, 12, 24, and 36 months
Primary Patient level characteristics Will be assessed by the effect of race/ethnicity, comorbid conditions, education level, gender, and age on patient reported outcomes. Interactions between intervention type and patient-level characteristics will be included. The distributions of variables will be summarized graphically and numerically. At baseline, 6, 12, 24, and 36 months after treatment
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04940299 - Tocilizumab, Ipilimumab, and Nivolumab for the Treatment of Advanced Melanoma, Non-Small Cell Lung Cancer, or Urothelial Carcinoma Phase 2
Recruiting NCT04953104 - Nivolumab for the Treatment of Patients With Metastatic Urothelial Cancer With ARID1A Mutation and Stratify Response Based on CXCL13 Expression Phase 2
Completed NCT03617913 - Avelumab in Combination With Fluorouracil and Mitomycin or Cisplatin and Radiation Therapy in Treating Participants With Muscle-Invasive Bladder Cancer Phase 2
Recruiting NCT04383743 - Pembrolizumab and Combination Chemotherapy Before Surgery for the Treatment of Muscle-Invasive Bladder Cancer Phase 2
Active, not recruiting NCT03775265 - Chemoradiotherapy With or Without Atezolizumab in Treating Patients With Localized Muscle Invasive Bladder Cancer Phase 3
Recruiting NCT05581589 - Sacituzumab Govitecan Before Radical Cystectomy for the Treatment of Non-Urothelial Muscle Invasive Bladder Cancer Phase 2
Completed NCT00749892 - Erlotinib Hydrochloride in Treating Participants With Muscle Invasive or Recurrent Urothelial Cancer Phase 2
Not yet recruiting NCT06263153 - Futibatinib in Combination With Durvalumab Prior to Cystectomy for the Treatment of Muscle-Invasive Bladder Cancer Patients Who Are Ineligible for Cisplatin-based Therapy Phase 2
Completed NCT03319745 - Pembrolizumab in Treating Patients With Bladder Cancer Undergoing Radical Cystectomy Phase 2
Active, not recruiting NCT04501913 - Remote Telemonitoring of Patient-Generated Physiologic Health Data and Patient-Reported Outcomes
Recruiting NCT06040762 - A Home-Based Prehabilitation Exercise Intervention for Improving Physical Function in Patients Receiving Chemotherapy Before Radical Cystectomy, Get Moving Trial N/A
Recruiting NCT04902040 - Plinabulin in Combination With Radiation/Immunotherapy in Patients With Select Advanced Cancers After Progression on PD-1 or PD-L1 Targeted Antibodies Phase 1/Phase 2