Trial Outcomes & Findings for Impact of Anticipated Regret Incorporation Into Patient Decision Aids (NCT NCT02563808)
NCT ID: NCT02563808
Last Updated: 2023-04-20
Results Overview
Compare decisions about a hypothetical surgery for breast cancer, and examined whether regret is a consideration in treatment decisions between those who received the experimental and those who received the standard version of the decision aid. The values represent numbers of participants who reported that regret played a role in their decision-making.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
189 participants
Primary outcome timeframe
11 months
Results posted on
2023-04-20
Participant Flow
Participant milestones
| Measure |
Survey: Standard Version
Females will receive standard decisions aid for early stage breast cancer.
Survey: Standard
|
Survey: Anticipated Regret Version
Females will receive anticipated regret-augmented version for early breast cancer.
Survey: Regret
|
|---|---|---|
|
Overall Study
STARTED
|
96
|
88
|
|
Overall Study
COMPLETED
|
96
|
88
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Impact of Anticipated Regret Incorporation Into Patient Decision Aids
Baseline characteristics by cohort
| Measure |
Survey: Standard Version
n=94 Participants
Females will receive standard decisions aid for early stage breast cancer.
Survey: Standard
|
Survey: Anticipated Regret Version
n=88 Participants
Females will receive anticipated regret-augmented version for early breast cancer.
Survey: Regret
|
Total
n=182 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
94 Participants
n=99 Participants
|
88 Participants
n=107 Participants
|
182 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
22.1 years
STANDARD_DEVIATION 7.2 • n=99 Participants
|
21.8 years
STANDARD_DEVIATION 5.9 • n=107 Participants
|
22.0 years
STANDARD_DEVIATION 6.6 • n=206 Participants
|
|
Sex: Female, Male
Female
|
94 Participants
n=99 Participants
|
88 Participants
n=107 Participants
|
182 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
82 Participants
n=99 Participants
|
72 Participants
n=107 Participants
|
154 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
33 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
68 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
19 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
54 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
94 Participants
n=99 Participants
|
88 Participants
n=107 Participants
|
182 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 11 monthsCompare decisions about a hypothetical surgery for breast cancer, and examined whether regret is a consideration in treatment decisions between those who received the experimental and those who received the standard version of the decision aid. The values represent numbers of participants who reported that regret played a role in their decision-making.
Outcome measures
| Measure |
Survey: Standard Version
n=96 Participants
Females will receive standard decisions aid for early stage breast cancer.
Survey: Standard
|
Survey: Anticipated Regret Version
n=88 Participants
Females will receive anticipated regret-augmented version for early breast cancer.
Survey: Regret
|
|---|---|---|
|
Difference in Consideration of Regret
|
62 participants reported regret played role
|
69 participants reported regret played role
|
Adverse Events
Survey: Standard Version
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Survey: Anticipated Regret Version
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place