NCT00769431

Brief Summary

RATIONALE: Collecting feedback from patients with prostate cancer may help doctors develop better symptom management educational materials for patients. PURPOSE: This clinical trial is evaluating symptom management educational materials for patients with prostate cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable prostate-cancer

Timeline
Completed

Started May 2008

Shorter than P25 for not_applicable prostate-cancer

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 8, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 9, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

July 26, 2013

Status Verified

July 1, 2013

Enrollment Period

11 months

First QC Date

October 8, 2008

Last Update Submit

July 24, 2013

Conditions

Keywords

stage I prostate cancerstage IIB prostate cancerstage IIA prostate cancer

Outcome Measures

Primary Outcomes (4)

  • Acceptability of the written patient educational materials, in terms of text size, white space, font, and graphics

    Single timepoint

  • Formative evaluation of the new educational materials, in terms of the comments made by the focus group participants

    Single timepoint

  • Validation that the goals of the educational-intervention instruction are being achieved

    Single timepoint

  • Improvement of the educational-intervention instruction by identification and remediation of problems

    Single timepoint

Study Arms (1)

Focus group

NO INTERVENTION
Other: educational interventionOther: study of socioeconomic and demographic variables

Interventions

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Biopsy-proven prostate cancer * Localized disease that has been previously treated * Selected for participation from 1 of the following: * Convenience sample of men from the Baylor College of Medicine (BCM) Urology clinics at Scurlock Tower (including the Urology clinic at MEDVAMC) and local prostate cancer-support groups * Prostate cancer survivors who participated in the US TOO Father's Day Walk/Run or the Gay Pride Celebration PATIENT CHARACTERISTICS: * Able to speak and read in English * Willing to review the written patient educational materials and discuss them in a group setting PRIOR CONCURRENT THERAPY: * See Disease Characteristics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Dan L. Duncan Cancer Center at Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Veterans Affairs Medical Center - Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health Services

Study Officials

  • David M. Latini, PhD

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 8, 2008

First Posted

October 9, 2008

Study Start

May 1, 2008

Primary Completion

April 1, 2009

Study Completion

July 1, 2009

Last Updated

July 26, 2013

Record last verified: 2013-07

Locations