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Completed

NCT Number: NCT01244568

Decision Support Interventions (DESI) for Prostate Cancer Screening and Treatment - Study 2

Researchers in this study will determine whether providing decision support interventions (DESIs) to men with low risk prostate cancer improves their decision-specific knowledge and alters their treatment decisions.

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Key information

Age range

45 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Palo Alto Medical Foundation Research Institute, Palo Alto, California, United States

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About this study

Potentially eligible men (age 45 and older who have localized prostate cancer with a Gleason score of 6 or less) will be identified and recruited to participate in the study before their next office visit. Patients who are interested and provide informed consent will be asked to complete a brief survey about background, medical history, knowledge of prostate cancer and health-related quality of life. Once the survey is completed the patient will be randomly assigned to one of 2 groups. Those assigned to the "Usual Care" group will not receive any additional information materials as part of their participation in the study. Those assigned to the "Patient Decision Support" group will receive a DVD program that contains information about treatment choices for prostate cancer.

Participants will be asked to answer a brief telephone survey at 3 and 6 months from the day of their last office visit. Survey questions will ask about knowledge about prostate cancer, health-related quality of life, whether or not the DVD was viewed and what treatment decision was made.

Research staff will also review medical records 6 months after enrollment to determine which treatment was received for prostate cancer, how many visits with health care providers were completed since enrollment and which medical services and procedures were received.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age 45 or older Localized prostate cancer with a Gleason score of 6 or less

Exclusion criteria

Women

Treatment and study plan

Prostate cancer treatment DESI

Behavioral

DESI is a 50 minute program on treatment choices for prostate cancer that will be given out to the experimental group. The program explains several treatment options including surgery (radical prostatectomy), radiation therapy (external beam and/or brachytherapy), hormone therapy, and active surveillance and watchful waiting. The program's intended audience is men with early state prostate cancer who are trying to make a treatment decision.

Other names: Decision Support Intervention

Primary outcomes

  1. Comparison of Active treatment vs. Watchful waiting/active surveillance at 3 and 6 months

    Time frame: 3 and 6 month follow-up

    Men who review a DESI before making a treatment decision will be more likely to choose active surveillance/watchful waiting and will have better decision-specific knowledge.

Secondary outcomes

  1. DESI viewing

    Time frame: 3 month follow-up (phone survey)

    Decision aid viewing is a self-reported measures. Patients will be asked if they viewed the DVD that was given to them (intervention group)prior to them making a treatment choice decision.

  2. Healthcare utilization

    Time frame: 6 month follow-up

    Research staff will review EMR data to access decision-making outcomes and resource utilization.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)
  • Palo Alto Medical Foundation

Registry information

Official study title

Acceleration Adoption of Comparative Effectiveness Research Results With Patient Decision Support Intervention and Treatment- Study 2

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Nov 19, 2010
Registry last updated
Dec 23, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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