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

NCT00207636 | Completed Results

• 1 other identifier: CDC-NCCDPHP-2504
• Study Type: interventional
• Target: 812
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer

Keywords

Computer-Assisted Decision Making; Workplace; Screening

Outcome Measures

Primary Outcomes (4)

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

  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.

  Assessed at baseline and follow-up, up to 10 months

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

  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.

  Assessed at baseline and follow-up, up to 10 months

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

  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).

  Assessed at baseline and follow-up, up to 10 months

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

  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.

  Assessed at baseline and follow-up, up to 10 months

Secondary Outcomes (2)

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

  Assessed at baseline and follow-up, up to 10 months

• Mean and Standard Error of a Scale to Measure Decisional Conflict

  Assessed at baseline and follow-up, up to 10 months

Study Arms (2)

Control

NO INTERVENTION

Distribution of printed materials

Computer Assisted Decision making tool

EXPERIMENTAL

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

Behavioral: Computer Assisted Decision making tool

Interventions

Computer Assisted Decision making tool BEHAVIORAL

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

Computer Assisted Decision making tool

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Centers for Disease Control and Prevention: lead
• Dana-Farber Cancer Institute: collaborator

Study Sites (1)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

• Allen JD, Othus MK, Hart A Jr, Tom L, Li Y, Berry D, Bowen D. A randomized trial of a computer-tailored decision aid to improve prostate cancer screening decisions: results from the Take the Wheel trial. Cancer Epidemiol Biomarkers Prev. 2010 Sep;19(9):2172-86. doi: 10.1158/1055-9965.EPI-09-0410. Epub 2010 Aug 17.

  PMID: 20716619 BACKGROUND

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

Limitations and Caveats

1. Overall use of the decision aid in the intervention group was lower. 2. Findings may not be generalizable to since study population was predominantly white and employed. 3. A new scale for decisional consistency was used. 4. Self-report values of prostate-specific antigen testing were used. 5. Short-term changes (3-months) were measured.

Results Point of Contact

• Title: Jennifer Allen
• Organization: DFCI, Harvard

617-632-2269

Study Officials

• Jennifer D Allen, PN MPH ScD

  Dana-Farber Cancer Institute; Harvard School of Public Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2005
• First Posted: September 21, 2005
• Study Start: December 1, 2004
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: January 14, 2025
• Results First Posted: January 14, 2025

Record last verified: 2024-12

Locations

US (1)