Trial Outcomes & Findings for Community Interventions in Non-medical Settings to Increase Informed Decision Making for Prostate Cancer Screening (NCT NCT00207636)

NCT ID: NCT00207636

Last Updated: 2025-01-14

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 812 participants
• Primary outcome timeframe: Assessed at baseline and follow-up, up to 10 months
• Results posted on: 2025-01-14

Participant Flow

Participant milestones

Measure	Control Group Distribution of printed material	Experimental Group The intervention is access to a computer-assisted decision-making tool designed to promote informed decision-making.
Overall Study STARTED	414	398
Overall Study COMPLETED	334	291
Overall Study NOT COMPLETED	80	107

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Control Group n=414 Participants Distribution of printed material	Intervention Group n=398 Participants The intervention is access to a computer-assisted decision-making tool designed to promote informed decision-making.	Total n=812 Participants Total of all reporting groups
Age, Customized 45 to 49 years old	120 Participants n=5 Participants	151 Participants n=7 Participants	271 Participants n=5 Participants
Age, Customized 50 to 54 years old	126 Participants n=5 Participants	106 Participants n=7 Participants	232 Participants n=5 Participants
Age, Customized 55 years old or older	153 Participants n=5 Participants	93 Participants n=7 Participants	246 Participants n=5 Participants
Age, Customized Missing age	15 Participants n=5 Participants	48 Participants n=7 Participants	63 Participants n=5 Participants
Sex/Gender, Customized Males	414 Participants n=5 Participants	398 Participants n=7 Participants	812 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Control n=334 Participants Distribution of printed material	Experimental n=291 Participants The intervention is access to a computer-assisted decision-making tool designed to promote informed decision-making.
Percentage of Patients Who Were Ready to Make a Decision or Were Undecided Decided : Baseline	134 Participants	90 Participants
Percentage of Patients Who Were Ready to Make a Decision or Were Undecided Decided : Follow-up	144 Participants	125 Participants
Percentage of Patients Who Were Ready to Make a Decision or Were Undecided Undecided : Baseline	200 Participants	201 Participants
Percentage of Patients Who Were Ready to Make a Decision or Were Undecided Undecided : Follow-up	190 Participants	166 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Control n=334 Participants Distribution of printed material	Experimental n=291 Participants The intervention is access to a computer-assisted decision-making tool designed to promote informed decision-making.
Percentage of Correct Responses in Assessing Mens' Recognition of the Prostate-specific Antigen Test and Knowledge Related to Prostate-cancer Topics. Baseline	56 percentage of correct responses Standard Error 1.23	56 percentage of correct responses Standard Error 2.68
Percentage of Correct Responses in Assessing Mens' Recognition of the Prostate-specific Antigen Test and Knowledge Related to Prostate-cancer Topics. Follow-up	60 percentage of correct responses Standard Error 1.6	66 percentage of correct responses Standard Error 2.08

PRIMARY outcome

Timeframe: 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).

Outcome measures

Measure	Control n=334 Participants Distribution of printed material	Experimental n=291 Participants The intervention is access to a computer-assisted decision-making tool designed to promote informed decision-making.
Mean and Standard Error of a Scale Used to Assess Men's Confidence Level in Making Decisions Related to Prostate Cancer Screening. Baseline	79 score on a scale Standard Error 1.59	83 score on a scale Standard Error 2.46
Mean and Standard Error of a Scale Used to Assess Men's Confidence Level in Making Decisions Related to Prostate Cancer Screening. Follow-up	79 score on a scale Standard Error 1.81	83 score on a scale Standard Error 2.36

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Control n=334 Participants Distribution of printed material	Experimental n=291 Participants The intervention is access to a computer-assisted decision-making tool designed to promote informed decision-making.
Percentage of Consistency Between Screening Preference and Personal Values Relevant to the Screening Decision Consistent: Baseline	244 Participants	207 Participants
Percentage of Consistency Between Screening Preference and Personal Values Relevant to the Screening Decision Consistent: Follow-up	247 Participants	201 Participants
Percentage of Consistency Between Screening Preference and Personal Values Relevant to the Screening Decision Inconsistent : Baseline	87 Participants	81 Participants
Percentage of Consistency Between Screening Preference and Personal Values Relevant to the Screening Decision Inconsistent : Follow-up	80 Participants	90 Participants
Percentage of Consistency Between Screening Preference and Personal Values Relevant to the Screening Decision Missing: Baseline	3 Participants	3 Participants
Percentage of Consistency Between Screening Preference and Personal Values Relevant to the Screening Decision Missing: Follow-up	7 Participants	1 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Control n=334 Participants Distribution of printed material	Experimental n=291 Participants The intervention is access to a computer-assisted decision-making tool designed to promote informed decision-making.
Percentage of Men Who Have Active Decision-making, Collaborative Decision-making, or Passive Decision-making Styles Baseline: active/collaborative	305 Participants	274 Participants
Percentage of Men Who Have Active Decision-making, Collaborative Decision-making, or Passive Decision-making Styles Follow-up: active/collaborative	308 Participants	277 Participants
Percentage of Men Who Have Active Decision-making, Collaborative Decision-making, or Passive Decision-making Styles Baseline: passive	28 Participants	15 Participants
Percentage of Men Who Have Active Decision-making, Collaborative Decision-making, or Passive Decision-making Styles Follow-up: passive	23 Participants	13 Participants
Percentage of Men Who Have Active Decision-making, Collaborative Decision-making, or Passive Decision-making Styles Baseline: missing	1 Participants	2 Participants
Percentage of Men Who Have Active Decision-making, Collaborative Decision-making, or Passive Decision-making Styles Follow-up: missing	3 Participants	1 Participants

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Control n=334 Participants Distribution of printed material	Experimental n=291 Participants The intervention is access to a computer-assisted decision-making tool designed to promote informed decision-making.
Mean and Standard Error of a Scale to Measure Decisional Conflict Baseline	28 score on a scale Standard Error 2.12	25 score on a scale Standard Error 2.08
Mean and Standard Error of a Scale to Measure Decisional Conflict Follow-up	20 score on a scale Standard Error 2.07	14 score on a scale Standard Error 2.01

Adverse Events

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Experimental

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jennifer Allen

DFCI, Harvard

Phone: 617-632-2269

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place