Impact of Anticipated Regret Incorporation Into Patient Decision Aids

NCT ID: NCT02563808

Last Updated: 2023-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 189 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2014-02-28

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.

Conditions

Regret

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Standard Decision Aid

The brochure with standard information on surgery for early-stage breast cancer

Group Type: ACTIVE_COMPARATOR

Standard Decision Aid

Intervention Type: OTHER

Females will receive standard decisions aid for early stage breast cancer.

Post-surgical Regret Decision Aid

The brochure that incorporates additional information on the rates of regret after surgical treatment of early-stage breast cancer.

Group Type: EXPERIMENTAL

Post-surgical Regret Decision Aid

Intervention Type: OTHER

Females will receive anticipated regret-augmented version for early breast cancer.

Interventions

Standard Decision Aid

Females will receive standard decisions aid for early stage breast cancer.

Intervention Type: OTHER

Post-surgical Regret Decision Aid

Females will receive anticipated regret-augmented version for early breast cancer.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Healthy females ages 18 years or older

Exclusion Criteria

• Under age 18 years

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lee Fleisher, MD

Role: PRINCIPAL_INVESTIGATOR

UPenn, Chairman, Anesthesiology & Critical Care

References

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.

Reference Type: DERIVED

PMID: 26941952 (View on PubMed)

Other Identifiers

817436

Identifier Type: -

Identifier Source: org_study_id