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OpenTrials
Completed

NCT Number: NCT02053389

Testing Decision Aids About Early Stage Prostate Cancer

This is an educational intervention study testing the effects of decision aids in promoting patient participation in early stage prostate cancer treatment decision making. The purpose of this study is to compare patient-physician communication between patients who receive a DVD that models patient communication strategies vs. those who do not receive a DVD. All patients will also receive a written decision aid that describes treatment options for early stage prostate cancer. The Investigators hypothesize that the DVD will:

* increase patients' perceptions of the importance of their preferences to their decision making * increase patients' perceptions of their intention to discuss their values and preferences with their urologists and radiation oncologists * increase patients' actual engagement with their physician during the clinical encounter * increase the concordance between patient decision making preferences and actual decision making outcomes * increase long term satisfaction with decision on type of treatment selected * increase patient satisfaction with their decision and the decision making process * influence patient perception of his physician (e.g., trust) and of the diagnosis visit

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Men aged 18 years and older
  • Scheduled for a prostate biopsy to test for prostate cancer
  • Ability to read and answer survey questions in English

Exclusion criteria

  • Previous diagnosis of prostate cancer

Treatment and study plan

DVD Decision Aid

Behavioral

The decision aid, "Discussing the Choice: Talking with your Doctor about Early Stage Prostate Cancer" is a DVD modeling patient communication strategies. The DVD includes vignettes with actors depicting patient-physician discussions of prostate cancer treatments. In these vignettes, the patient models communication strategies designed to facilitate patient activation.

Written decision aid

Behavioral

A written decision aid entitled "Making the Choice: Deciding What to Do About Early Stage Prostate Cancer" that describes treatment options for early stage prostate cancer.

Primary outcomes

  1. Self-efficacy for discussing preferences (intention)

    Time frame: Time 1 (baseline)

    14 item survey instrument

  2. Self-efficacy for discussing preferences (intention)

    Time frame: Time 2 (post-intervention, an average of 3 days after Time 1 baseline)

    14 item survey instrument

  3. Self-efficacy for discussing preferences (actual)

    Time frame: Time 3 (post-diagnosis, an average of 1 month after Time 1 baseline)

    14 item survey instrument

Secondary outcomes

  1. Preference for shared decision making

    Time frame: Time 1 (baseline)

    1 item survey instrument

  2. Preference for shared decision making

    Time frame: Time 2 (post-intervention, an average of 3 days after Time 1 baseline)

    1 item survey instrument

  3. Prostate cancer related knowledge

    Time frame: Time 1 (baseline)

    10 item survey instrument

  4. Prostate cancer related knowledge

    Time frame: Time 2 (post-intervention, an average of 3 days after Time 1 baseline)

    10 item survey instrument

  5. Prostate cancer related knowledge

    Time frame: Time 3 (post-diagnosis, an average of 1 month after Time 1 baseline)

    12 item survey instrument

  6. Prostate cancer related anxiety

    Time frame: Time 1 (baseline)

    6 item survey instrument

  7. Prostate cancer related anxiety

    Time frame: Time 2 (post-intervention, an average of 3 days after Time 1 baseline)

    6 item survey instrument

  8. Prostate cancer related anxiety

    Time frame: Time 3 (post-diagnosis, an average of 1 month after Time 1 baseline)

    6 item survey instrument

  9. Prostate cancer related anxiety

    Time frame: Time 4 (6 months post diagnosis)

    7 item survey instrument

  10. Treatment preference

    Time frame: Time 2 (post-intervention, an average of 3 days after Time 1 baseline)

    1 item survey instrument

  11. Treatment decision

    Time frame: Time 3 (post-diagnosis, an average of 1 month after Time 1 baseline)

    2 item survey instrument

  12. Treatment decision

    Time frame: Time 4 (6 months post diagnosis)

    2 item survey instrument

  13. Decisional regret

    Time frame: Time 4 (6 months post diagnosis)

    5 item survey instrument

  14. Preference for shared decision making

    Time frame: Time 3 (post-diagnosis, an average of 1 month after Time 1 baseline)

    1 item survey instrument

  15. Preference for shared decision making

    Time frame: Time 4 (6 months post diagnosis)

    1 item survey instrument

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Promoting Shared Decision Making in Prostate Cancer Through Decision Aids

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Feb 3, 2014
Registry last updated
Jun 1, 2015

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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