Impact of Anticipated Regret Incorporation Into Patient Decision Aids

Regret Clinical Trial

Official title:

Impact of Anticipated Regret on Decision-Making in Preference Sensitive Care for Breast and Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02563808
• Other study ID #: 817436
• Status: Completed
• Phase: N/A
• Start date: March 2013
• Est. completion date: February 2014

Study information

• Verified date: April 2023
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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."

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 189
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Healthy females ages 18 years or older

Exclusion Criteria:

• Under age 18 years

Related Conditions & MeSH terms

• Regret

Intervention

Other:
• Standard Decision Aid
Females will receive standard decisions aid for early stage breast cancer.
• Post-surgical Regret Decision Aid
Females will receive anticipated regret-augmented version for early breast cancer.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	11 months