Impact of Anticipated Regret Incorporation Into Patient Decision Aids

Not Applicable

Completed

• Conditions: Regret
• Interventions: Other: Standard Decision Aid; Other: Post-surgical Regret Decision Aid

• Registration Number: NCT02563808
• Lead Sponsor: University of Pennsylvania

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.

Study Timeline

• Study Start: 2013-03
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Study First Submitted: 2015-09-28
• Study First Submitted QC: 2015-09-29
• Study First Posted: 2015-09-30
• Results First Submitted: 2017-10-26
• Results First Submitted QC: 2019-02-14
• Results First Posted: 2019-05-31
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-18
• Last Update Posted: 2023-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 189

Inclusion Criteria

• Healthy females ages 18 years or older

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Exclusion Criteria

• Under age 18 years

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Decision Aid	Standard Decision Aid	The brochure with standard information on surgery for early-stage breast cancer
Post-surgical Regret Decision Aid	Post-surgical Regret Decision Aid	The brochure that incorporates additional information on the rates of regret after surgical treatment of early-stage breast cancer.

Primary Outcome Measures

Name	Time	Method
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.