Regret
Conditions
Brief summary
The purpose of this study is to investigate the impact of incorporating anticipated regret into standard patient decision aids. Participants in the Wharton Behavioral Lab will be administered a standard patient decision aid and an anticipated regret augmented decision aid. Participants will complete a computerized survey about their experiences with each version, and their answers will be assessed for potential differences associated with the incorporation of Anticipated Regret.
Detailed description
Participants will be recruited through the Wharton Behavioral Lab. Upon arrival males will be provided with two decision aids focusing on prostate cancer, while females will be provided with two decision aids focusing on early breast cancer. One of these decision aids will be a standard version, and one of these will be the anticipated regret-augmented version. Participants will be randomized to which version they receive first to minimize the effect of presentation order. After reviewing the materials, participants will immediately complete a computerized survey at their work stations that will ask them to answer questions based on the materials presented as well as how any hypothetical treatment decisions they would be asked to make would have been influenced by them. Because these are healthy subjects participating in a hypothetical decision-making process for sole purpose of research, the intervention can neither be categorized as experimental or as the standard of care.
Interventions
OTHERStandard Decision Aid
Females will receive standard decisions aid for early stage breast cancer.
OTHERPost-surgical Regret Decision Aid
Females will receive anticipated regret-augmented version for early breast cancer.
Sponsors
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Healthy females ages 18 years or older
Exclusion criteria
* Under age 18 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Consideration of Regret | 11 months | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Survey: Standard Version Females will receive standard decisions aid for early stage breast cancer.
Survey: Standard | 94 |
| Survey: Anticipated Regret Version Females will receive anticipated regret-augmented version for early breast cancer.
Survey: Regret | 88 |
| Total | 182 |
Baseline characteristics
| Characteristic | Survey: Standard Version | Survey: Anticipated Regret Version | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 94 Participants | 88 Participants | 182 Participants |
| Age, Continuous | 22.1 years STANDARD_DEVIATION 7.2 | 21.8 years STANDARD_DEVIATION 5.9 | 22.0 years STANDARD_DEVIATION 6.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 7 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 82 Participants | 72 Participants | 154 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 7 Participants | 9 Participants | 16 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 33 Participants | 35 Participants | 68 Participants |
| Race (NIH/OMB) Black or African American | 19 Participants | 13 Participants | 32 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 7 Participants | 12 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants | 9 Participants | 16 Participants |
| Race (NIH/OMB) White | 30 Participants | 24 Participants | 54 Participants |
| Region of Enrollment United States | 94 Participants | 88 Participants | 182 Participants |
| Sex: Female, Male Female | 94 Participants | 88 Participants | 182 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 94 | 0 / 88 |
| serious Total, serious adverse events | 0 / 96 | 0 / 88 |
Outcome results
Primary
Difference in Consideration of Regret
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.
Time frame: 11 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Survey: Standard Version | Difference in Consideration of Regret | 62 participants reported regret played role |
| Survey: Anticipated Regret Version | Difference in Consideration of Regret | 69 participants reported regret played role |