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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00207636

Enrollment

812

Registered

2005-09-21

Start date

2004-12-31

Completion date

2009-08-31

Last updated

2025-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

Computer-Assisted Decision Making, Workplace, Screening

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.

Detailed description

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.

Interventions

BEHAVIORALComputer Assisted Decision making tool

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

45 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Patients Who Were Ready to Make a Decision or Were Undecided	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.
Percentage of Correct Responses in Assessing Mens' Recognition of the Prostate-specific Antigen Test and Knowledge Related to Prostate-cancer Topics.	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.
Mean and Standard Error of a Scale Used to Assess Men's Confidence Level in Making Decisions Related to Prostate Cancer Screening.	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).
Percentage of Consistency Between Screening Preference and Personal Values Relevant to the Screening Decision	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

Measure	Time frame	Description
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	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.
Mean and Standard Error of a Scale to Measure Decisional Conflict	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).

Countries

United States

Participant flow

Participants by arm

Arm	Count
Control Group Distribution of printed material	414
Intervention Group The intervention is access to a computer-assisted decision-making tool designed to promote informed decision-making.	398
Total	812

Baseline characteristics

Characteristic	Control Group	Intervention Group	Total
Age, Customized 45 to 49 years old	120 Participants	151 Participants	271 Participants
Age, Customized 50 to 54 years old	126 Participants	106 Participants	232 Participants
Age, Customized 55 years old or older	153 Participants	93 Participants	246 Participants
Age, Customized Missing age	15 Participants	48 Participants	63 Participants
Sex/Gender, Customized Males	414 Participants	398 Participants	812 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 0	0 / 0
other Total, other adverse events	0 / 0	0 / 0
serious Total, serious adverse events	0 / 0	0 / 0

Outcome results

Primary

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).