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Completed

NCT Number: NCT00207636

Community Interventions in Non-medical Settings to Increase Informed Decision Making for Prostate Cancer Screening

The purpose of this study is to develop and evaluate a computer-based decision aid (DA) for use by men considering prostate-specific antigen (PSA) screening for prostate cancer. Major medical organizations recommend that men discuss the risks and benefits of this test with their physician before making the decision. This educational, interactive DA will help them prepare for that discussion.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

45 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

About this study

Prostate cancer (CaP) is a formidable public health problem in the US and in industrialized countries worldwide. Methods for primary prevention of CaP are unknown. As a result, early detection has become a mainstay of cancer control efforts. However, there is considerable controversy regarding the efficacy of screening in reducing disease-specific mortality. In light of this uncertainty, major medical organizations, including the National Cancer Institute, currently recommend that men discuss the pros and cons of CaP screening and make individualized screening decisions with their health care providers. However, because of constraints on time during medical encounters, it is not always feasible for providers to engage in in-depth discussions regarding the complexities of this issue. Therefore, interventions to promote informed decision-making (IDM) outside of clinical settings are needed.

In this study, we propose to: (1) develop an interactive computer-based decision aid (DA) to promote IDM for CaP screening; and (2) conduct a randomized controlled worksite trial to evaluate the impact the DA intervention on employed men's ability to make informed decisions regarding CaP. This work is designed to be responsive to recent calls for IDM interventions in community settings among diverse populations. If successful, our findings could validate the effectiveness of DAs to promote IDM for CaP and serve as a model for widespread dissemination, thus improving quality of care.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Worksites employing at least 100 men in target age group (45-65 years old)

Exclusion criteria

  • Worksites with high turnover
  • Non-English speaking workers
  • Temporary or contract workers

Treatment and study plan

Computer Assisted Decision making tool

Behavioral

The intervention consisted of access to a computer tailored decision aid designed to promote informed decision making.

Primary outcomes

  1. Percentage of Patients Who Were Ready to Make a Decision or Were Undecided

    Time frame: Assessed at baseline and follow-up, up to 10 months

    Readiness to make a decision based on Stage of Decision-Making Scale (O'Connor A et al, 2008) with five responses ranging from "I haven't thought about it before" to "I have made a decision, and I am not likely to change my mind." Men were classified as having "decided" if they stated either that they had made a decision, but were willing to reconsider, or if they responded that they had made a decision but were unlikely to change their mind. Those "undecided" reported that they had not thought about the decision, or were uncertain.

  2. Percentage of Correct Responses in Assessing Mens' Recognition of the Prostate-specific Antigen Test and Knowledge Related to Prostate-cancer Topics.

    Time frame: Assessed at baseline and follow-up, up to 10 months

    Recognition of test based upon a standard single item and 14 validated questions assessed knowledge of prostate cancer prevalence, risk factors, screening modalities, diagnostic procedures, and treatment-related complications.

  3. Mean and Standard Error of a Scale Used to Assess Men's Confidence Level in Making Decisions Related to Prostate Cancer Screening.

    Time frame: Assessed at baseline and follow-up, up to 10 months

    The confidence in ability to participate in decision making to the extent desired using the 11-item Decision Self-Efficacy Scale was assessed. Respondents were asked to reflect on their confidence level about various aspects of the decision-making process, with response options of "very confident" (score = 4) to "not at all confident" (score = 0). Scores were summed, divided by 11, and multiplied by 25, to arrive at a range of scores from 0 (no self-efficacy) to 100 (higher self-efficacy).

  4. Percentage of Consistency Between Screening Preference and Personal Values Relevant to the Screening Decision

    Time frame: Assessed at baseline and follow-up, up to 10 months

    Items were developed to assess the personal importance or relative worth of the advantages and limitations of screening based on focus group themes and published literature. Some to the themes include: importance of information, accuracy of test, potential side effects of treatment.

Secondary outcomes

  1. Percentage of Men Who Have Active Decision-making, Collaborative Decision-making, or Passive Decision-making Styles

    Time frame: Assessed at baseline and follow-up, up to 10 months

    Assessed through the Control Preferences Scale (Degner LF et al, 1997). Individuals were assessed who should make medical decisions. The active decision-making category included responses where men made the final decision on their own or after considering their doctor's opinions. The collaborative decision-making category included responses where men and their doctors shared the responsibility for the decision. The passive decision-making category included responses where the doctors made the final decision after considering a man's input or that the doctor made the final decision.

  2. Mean and Standard Error of a Scale to Measure Decisional Conflict

    Time frame: Assessed at baseline and follow-up, up to 10 months

    Measured through the Decisional Conflict Scale (O'Connor AM et al, 2003) by rating statements related to decision making and responding on a five-point scale ranging from "strongly agree' to "strongly disagree". Scales were standardized from 0 (no conflict) to 100 (extreme conflict).

Sponsors and collaborators

Lead sponsor

Centers for Disease Control and Prevention

Fed

Collaborators

  • Dana-Farber Cancer Institute

Registry information

Official study title

Community Interventions in Non-medical Settings to Increase Informed Decision Making for Prostate Cancer Screening - Harvard - SIP 21-04

Important dates

Study start
2004
Primary completion
2009
Study completion
2009
First posted
Sep 21, 2005
Registry last updated
Jan 14, 2025

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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