Health-Related Quality of Life in Patients With Bladder Cancer

NCT ID: NCT00744744

Last Updated: 2012-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

138 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-05-31

Study Completion Date

2011-07-31

Brief Summary

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RATIONALE: Gathering information about quality of life in patients with cancer may improve the ability to plan treatment and may help patients live more comfortably.

PURPOSE: This clinical trial is studying health-related quality of life in patients with bladder cancer.

Detailed Description

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OBJECTIVES:

* To identify aspects of survivorship experience that differ by clinical risk (low risk vs high risk) in patients with non-invasive bladder cancer.
* To collect and examine data on health-related quality of life (HRQOL) and symptom management.
* To analyze differences in outcomes between genders, stage and grade of disease, and recency of diagnosis (new diagnosis vs ≥ 6 month diagnosis).

OUTLINE: Patients undergo a 45-minute telephone interview to assess their current medical condition and psychological functioning (i.e., bladder cancer treatment history, levels of depression and anxiety, quality of life, self-efficacy, and perceived social support). Patients complete a series of questionnaires including the Lepore social constraint measure; REACH social support measure; self-report inventories assessing patient communication, relationship style, illness intrusiveness, fear of recurrence, and social constraint; Impact of Events scale; Brief Symptom Index-18 and Global Severity Index; EORTC QLQ-C30 (general health-related quality of life); and EORTC QLC-BLS24 (disease-specific health-related quality of life).

Conditions

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Bladder Cancer

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Survey

informational intervention

Intervention Type OTHER

Patient educational information

questionnaire administration

Intervention Type OTHER

Survey

management of therapy complications

Intervention Type PROCEDURE

Survey

psychosocial assessment and care

Intervention Type PROCEDURE

Survey

quality-of-life assessment

Intervention Type PROCEDURE

Survey

Interventions

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informational intervention

Patient educational information

Intervention Type OTHER

questionnaire administration

Survey

Intervention Type OTHER

management of therapy complications

Survey

Intervention Type PROCEDURE

psychosocial assessment and care

Survey

Intervention Type PROCEDURE

quality-of-life assessment

Survey

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

DISEASE CHARACTERISTICS:

* Diagnosis of non-invasive bladder cancer within the past 4 years

PATIENT CHARACTERISTICS:

* Not pregnant
* Able to read, speak, and understand English

PRIOR CONCURRENT THERAPY:

* Not specified
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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David Latini

OTHER

Sponsor Role lead

Responsible Party

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David Latini

Assistant Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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David M. Latini, PhD

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Locations

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Dan L. Duncan Cancer Center at Baylor College of Medicine

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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BCM-H-21350

Identifier Type: -

Identifier Source: secondary_id

CDR0000600461

Identifier Type: -

Identifier Source: org_study_id

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