Quality of Life After Treatment for Bla… | Clinical Trial

Key information

Conditions

Stage 0a Bladder Cancer AJCC v8 Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Site Stage 0is Bladder Cancer AJCC v8 Stage I Bladder Cancer AJCC v8 Stage II Bladder Cancer AJCC v8 Stage IIIA Bladder Cancer AJCC v8 Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic in Arizona, Scottsdale, Arizona, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-Interventional Study

Other

Non-Interventional Study

Primary outcomes

Change in quality of life outcomes - PROMIS-29

Time frame: At baseline, 6, 12, 24, and 36 months

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.
Change in quality of life outcomes - Bladder Cancer Index

Time frame: At baseline, 6, 12, 24, and 36 months

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".
Patient level characteristics

Time frame: At baseline, 6, 12, 24, and 36 months after treatment

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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start: 2018
Primary completion: 2029
Study completion: 2029
First posted: Apr 5, 2024
Registry last updated: Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed