NCT02563808

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."

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
189

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2013

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 28, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 30, 2015

Completed
3.7 years until next milestone

Results Posted

Study results publicly available

May 31, 2019

Completed
Last Updated

April 20, 2023

Status Verified

April 1, 2023

Enrollment Period

11 months

First QC Date

September 28, 2015

Results QC Date

October 26, 2017

Last Update Submit

April 18, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Standard Decision Aid

ACTIVE COMPARATOR

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

Other: Standard Decision Aid

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.

Other: Post-surgical Regret Decision Aid

Interventions

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

Standard Decision Aid

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

Post-surgical Regret Decision Aid

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsHealthy females ages 18 and older
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy females ages 18 years or older

You may not qualify if:

  • Under age 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

Results Point of Contact

Title
Lee Fleisher
Organization
University of Pennsylvania Hospital

Study Officials

  • Lee Fleisher, MD

    UPenn, Chairman, Anesthesiology & Critical Care

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2015

First Posted

September 30, 2015

Study Start

March 1, 2013

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

April 20, 2023

Results First Posted

May 31, 2019

Record last verified: 2023-04