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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."
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Decision Aid | Active Comparator | The brochure with standard information on surgery for early-stage breast cancer |
|
| Post-surgical Regret Decision Aid | Experimental | The brochure that incorporates additional information on the rates of regret after surgical treatment of early-stage breast cancer. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Decision Aid | Other | Females will receive standard decisions aid for early stage breast cancer. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 11 months |
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Inclusion Criteria:
Exclusion Criteria:
Healthy females ages 18 and older
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| Name | Affiliation | Role |
|---|---|---|
| Lee Fleisher, MD | UPenn, Chairman, Anesthesiology & Critical Care | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26941952 | Derived | Speck RM, Neuman MD, Resnick KS, Mellers BA, Fleisher LA. Anticipated regret in shared decision-making: a randomized experimental study. Perioper Med (Lond). 2016 Mar 2;5:5. doi: 10.1186/s13741-016-0031-6. eCollection 2016. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Survey: Standard Version | Females will receive standard decisions aid for early stage breast cancer. Survey: Standard |
| FG001 | Survey: Anticipated Regret Version | Females will receive anticipated regret-augmented version for early breast cancer. Survey: Regret |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Two participants did not complete the demographic questions. As such only 94 are being analyzed.
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| ID | Title | Description |
|---|---|---|
| BG000 | Survey: Standard Version | Females will receive standard decisions aid for early stage breast cancer. Survey: Standard |
| BG001 | Survey: Anticipated Regret Version | Females will receive anticipated regret-augmented version for early breast cancer. Survey: Regret |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | participants reported regret played role | 11 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Survey: Standard Version | Females will receive standard decisions aid for early stage breast cancer. Survey: Standard |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lee Fleisher | University of Pennsylvania Hospital | 2156623738 | lee.fleisher@uphs.upenn.edu |
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| Post-surgical Regret Decision Aid | Other | Females will receive anticipated regret-augmented version for early breast cancer. |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Female only | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
|
|
|
| 0 |
| 96 |
| 0 |
| 94 |
| EG001 | Survey: Anticipated Regret Version | Females will receive anticipated regret-augmented version for early breast cancer. Survey: Regret | 0 | 88 | 0 | 88 |
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