Trial Outcomes & Findings for Shared Decision-Making for Colorectal Cancer Screening (NCT NCT00251862)

NCT ID: NCT00251862

Last Updated: 2013-12-27

Results Overview

Completion of a screening test within 12 months of the study visit.

Recruitment status

COMPLETED

Study phase

Target enrollment

825 participants

Primary outcome timeframe

12 months post-intervention

Results posted on

2013-12-27

Participant Flow

Participant milestones

Participant milestones
Measure	DA + YDR Decision aid (DA) plus Your Disease Risk (YDR) personalized risk feedback	DA Alone Decision aid alone	Control Standard Care
Overall Study STARTED	280	269	276
Overall Study COMPLETED	280	269	276
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Shared Decision-Making for Colorectal Cancer Screening

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DA + YDR n=280 Participants Decision aid (DA) plus Your Disease Risk (YDR) personalized risk feedback	DA Alone n=269 Participants Decision aid alone	Control n=276 Participants Standard Care	Total n=825 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	232 Participants n=5 Participants	234 Participants n=7 Participants	230 Participants n=5 Participants	696 Participants n=4 Participants
Age, Categorical >=65 years	48 Participants n=5 Participants	35 Participants n=7 Participants	46 Participants n=5 Participants	129 Participants n=4 Participants
Sex: Female, Male Female	163 Participants n=5 Participants	164 Participants n=7 Participants	159 Participants n=5 Participants	486 Participants n=4 Participants
Sex: Female, Male Male	117 Participants n=5 Participants	105 Participants n=7 Participants	117 Participants n=5 Participants	339 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	18 Participants n=5 Participants	10 Participants n=7 Participants	15 Participants n=5 Participants	43 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	262 Participants n=5 Participants	259 Participants n=7 Participants	261 Participants n=5 Participants	782 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	7 Participants n=7 Participants	2 Participants n=5 Participants	12 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	172 Participants n=5 Participants	160 Participants n=7 Participants	180 Participants n=5 Participants	512 Participants n=4 Participants
Race (NIH/OMB) White	99 Participants n=5 Participants	96 Participants n=7 Participants	88 Participants n=5 Participants	283 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants	18 Participants n=4 Participants
Region of Enrollment United States	280 participants n=5 Participants	269 participants n=7 Participants	276 participants n=5 Participants	825 participants n=4 Participants

PRIMARY outcome

Timeframe: 12 months post-intervention

Population: Intention to treat

Completion of a screening test within 12 months of the study visit.

Outcome measures

Outcome measures
Measure	DA + YDR n=280 Participants Decision aid (DA) plus Your Disease Risk (YDR) personalized risk feedback	DA Alone n=269 Participants Decision aid alone	Control n=276 Participants Standard Care
Patient Adherence (Test Completion)	104 participants	116 participants	96 participants

SECONDARY outcome

Timeframe: Immediate post-intervention study visit

Knowledge was assessed at baseline (pretest) and at the time of the exit survey (posttest) based on responses to a 12-item questionnaire (True/False/Don't know) that inquired about CRC risk factors, the rationale and goals of screening, and age at which screening should begin. Cumulative knowledge scores (range, 0-12) were derived by summing correct responses to the 12 individual knowledge questions.

Outcome measures

Outcome measures
Measure	DA + YDR n=280 Participants Decision aid (DA) plus Your Disease Risk (YDR) personalized risk feedback	DA Alone n=269 Participants Decision aid alone	Control n=276 Participants Standard Care
Patient Knowledge	10.7 units on a scale Standard Deviation 1.9	10.9 units on a scale Standard Deviation 1.6	8.6 units on a scale Standard Deviation 2.6

SECONDARY outcome

Timeframe: Immediate post-intervention primary care provider (PCP) visit

Patient satisfaction with the decision-making process (SDMP) was assessed using the validated 12-item Satisfaction with the Decision-Making Process scale. Five ordered response categories were used for each item. Each response was assigned a point score ranging from 1 for "strongly disagree" (or "poor") to 5 for "strongly agree" (or "excellent"). A cumulative score was calculated based on the summed response scores for each item (maximum score = 60). Mean item substitution was used to impute missing data.

Outcome measures

Outcome measures
Measure	DA + YDR n=280 Participants Decision aid (DA) plus Your Disease Risk (YDR) personalized risk feedback	DA Alone n=269 Participants Decision aid alone	Control n=276 Participants Standard Care
Patient Satisfaction With Decision Making Process	49.0 units on a scale Standard Deviation 6.2	49.7 units on a scale Standard Deviation 6.4	45.5 units on a scale Standard Deviation 7.8

SECONDARY outcome

Timeframe: Immediate post-intervention study visit

Screening intentions were also assessed as part of the posttest. Subjects were asked how sure they were that they would schedule an appointment to get screened for colorectal cancer and how sure they were that they would complete the screening test they scheduled. An ordered 5-point response frame was used ranging from 1 for "not at all sure" to 5 for "completely sure".

Outcome measures

Outcome measures
Measure	DA + YDR n=280 Participants Decision aid (DA) plus Your Disease Risk (YDR) personalized risk feedback	DA Alone n=269 Participants Decision aid alone	Control n=276 Participants Standard Care
Screening Intentions	4.4 units on a scale Standard Deviation 1.0	4.4 units on a scale Standard Deviation 1.0	4.0 units on a scale Standard Deviation 1.3

Adverse Events

DA + YDR

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

DA Alone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

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

Dr. Paul C. Schroy III

Boston Medical Center

Phone: 617-638-8335

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place