Effect of Dietary, Lifestyle, and Environmental Factors on Patients With Early-Stage Bladder Cancer

• Conditions: Bladder Cancer

• Registration Number: NCT00553566
• Lead Sponsor: University of Birmingham

Brief Summary

RATIONALE: Learning about the long-term effects of dietary, lifestyle, and environmental factors on the risk of cancer progression and recurrence may help the study of bladder cancer in the future.

PURPOSE: This clinical trial is studying how dietary, lifestyle, and environmental factors affect patients with early-stage bladder cancer.

Detailed Description

OBJECTIVES:

* To examine if common and potentially modifiable dietary, lifestyle, and environmental exposures affect the risk of recurrence and progression in bladder cancer.

OUTLINE: This is a multicenter study.

Detailed information will be collected about the patients' lifestyle and their exposure to risk factors associated with bladder cancer using semi-structured questionnaires. A baseline questionnaire will be administered at the time of diagnosis and will collect information about socio-demographics, environmental exposures, medical history, diet, health-related quality of life, and social support.

Further questionnaires will be administered at regular follow-up visits to capture information relating to changes in exposure. A postal questionnaire will be used to collect historical information that may require the patient to check records or consult family or friends. Patients will also be asked to keep a 1-week food, fluid, and micturition diary.

Patients continue to complete questionnaires at 3 months and then annually for up to 5 years.

Peer Reviewed and Funded or Endorsed by Cancer Research UK.

Study Timeline

• Study Start: 2005-12
• Study First Submitted: 2007-11-02
• Study First Submitted QC: 2007-11-02
• Study First Posted: 2007-11-04
• Status Verified: 2010-02
• Last Update Submitted: 2014-01-09
• Last Update Posted: 2014-01-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1600

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recurrence at 5 years
Progression at 5 years

Trial Locations

Locations (1)

University of Birmingham; 🇬🇧 Edgbaston, England, United Kingdom