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Active, not recruitingNCT06350734Updated Apr 17, 2026

Quality of Life After Treatment for Bladder Cancer: The Bladder Cancer Survivorship Study

An observational study in Stage 0a Bladder Cancer AJCC v8, Stage 0is Bladder Cancer AJCC v8 and Stage I Bladder Cancer AJCC v8, sponsored by Mayo Clinic. Active, not recruiting at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-17.

Sponsored by Mayo Clinic · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
204
Ages
18 Years and older
Sex
All
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Study summary

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

Read the detailed 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.

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Conditions studied

  • Stage 0a Bladder Cancer AJCC v8
  • Stage 0is Bladder Cancer AJCC v8
  • Stage I Bladder Cancer AJCC v8
  • Stage II Bladder Cancer AJCC v8
  • Stage IIIA Bladder Cancer AJCC v8
03

In context

Urinary Bladder Neoplasms

1,616 studies on the registry are indexed under Urinary Bladder Neoplasms; 421 are open to participants now.

This study's enrollment of 204 is above the median of 180 across 374 observational studies indexed under Urinary Bladder Neoplasms.

Browse Urinary Bladder Neoplasms studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Men and women diagnosed with clinically localized bladder cancer

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

Exclusion Criteria:

  • Does not meet inclusion criteria
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
204 participants (actual)

Groups and cohorts

  • Observational

    Patients complete surveys and also have their medical records reviewed on study.

    Other: Non-Interventional Study

Interventions

  • OtherNon-Interventional Study

    Non-Interventional Study

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What researchers measure

Primary outcomes

  1. 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.

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

  2. 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".

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

  3. 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.

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

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Study locations

3 sites
  • Mayo Clinic in Arizona
    Scottsdale, Arizona 85259, United States
  • Mayo Clinic in Florida
    Jacksonville, Florida 32224-9980, United States
  • Mayo Clinic in Rochester
    Rochester, Minnesota 55905, United States
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References and documents

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06350734
Lead sponsor
Mayo Clinic
Responsible party
Sponsor
First posted
Apr 5, 2024
Start date
Oct 12, 2018
Primary completion
Jan 31, 2029 (estimated)
Completion
Jan 31, 2029 (estimated)
Last update
Apr 17, 2026

Study contacts

Mark D. Tyson, M.D., M.P.H.
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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