Prostate Cancer Symptom Management for Low Literacy Men

NCT00983710 | Completed Phase 2 DMC

• 1 other identifier: MRSGT-06-083-01-CPPB
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

This study will compare a newly-developed patient education program to help men with localized prostate cancer manage treatment-related side-effects versus usual care. The new intervention will be developed for men with lower health literacy. That means that the education materials will be developed for sixth grade reading level or lower. The materials will include lots of examples and illustrations to make it easier for people understand the information.

Conditions

Prostate Cancer

Keywords

prostate neoplasms

Outcome Measures

Primary Outcomes (1)

• Sexual Bother score from Expanded Prostate Cancer Index Urinary Bother score from Expanded Prostate Cancer Index

  Six months post-baseline

Study Arms (2)

1

EXPERIMENTAL

Participants will receive a new patient education program designed to help men manage side-effects related to treatment for localized prostate cancer. The intervention will be targeted to low health literacy men.

Behavioral: PC-PEP - Prostate Cancer Patient Education Program

2

ACTIVE COMPARATOR

Usual care, including a booklet on coping with localized prostate cancer. After the 6-month primary outcome data are collected, control group men will be offered the opportunity to cross-over and receive the new educational intervention.

Behavioral: Usual care

Interventions

PC-PEP - Prostate Cancer Patient Education Program BEHAVIORAL

Men in the intervention group will receive a new patient education intervention to help them manage side-effects related to treatment for localized prostate cancer. The intervention will be delivered by phone and by mail and is targeted to me with low health literacy. The intervention consists of written materials, audio materials, and telephone-based problem-solving education.

1

Usual care BEHAVIORAL

Booklet on coping with localized prostate cancer

2

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male
• years or older, with biopsy-proven prostate cancer
• Diagnosed with localized disease in the preceding 2 years
• Have a telephone at the time of enrollment
• Have an address where they can receive intervention materials by mail
• Able to speak and understand English
• Treated with radiation, surgery, or hormonal therapy
• Receive prostate cancer treatment and follow-up at the Michael E DeBakey VA Medical Center in Houston, TX

You may not qualify if:

• Younger than 18
• Female
• Diagnosis of advanced prostate cancer
• No treatment for prostate cancer
• Diagnosed with localized disease more than 2 years before trial enrollment
• Unable to speak and understand English
• Unable to provide informed consent

Sponsors & Collaborators

• Baylor College of Medicine: lead
• American Cancer Society, Inc.: collaborator
• Michael E. DeBakey VA Medical Center: collaborator

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• David M Latini, PhD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Urology

Study Record Dates

• First Submitted: September 22, 2009
• First Posted: September 24, 2009
• Study Start: May 1, 2009
• Primary Completion: October 1, 2011
• Study Completion: December 1, 2017
• Last Updated: January 23, 2018

Record last verified: 2018-01

Locations

US (1)