Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT02563808
Previous Study | Return to List | Next Study

Impact of Anticipated Regret Incorporation Into Patient Decision Aids

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02563808
Recruitment Status : Completed
First Posted : September 30, 2015
Results First Posted : May 31, 2019
Last Update Posted : May 31, 2019
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

Tracking Information
First Submitted Date  ICMJE September 28, 2015
First Posted Date  ICMJE September 30, 2015
Results First Submitted Date  ICMJE October 26, 2017
Results First Posted Date  ICMJE May 31, 2019
Last Update Posted Date May 31, 2019
Study Start Date  ICMJE March 2013
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 14, 2019)
Difference in Consideration of Regret [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 29, 2015)
Patient Decision Making [ Time Frame: One year ]
Compare decisions about a hypothetical surgery for breast cancer, and examined whether regret is a consideration in treatment decisions.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of Anticipated Regret Incorporation Into Patient Decision Aids
Official Title  ICMJE Impact of Anticipated Regret on Decision-Making in Preference Sensitive Care for Breast and Prostate Cancer
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Regret
Intervention  ICMJE
  • Other: Standard Decision Aid
    Females will receive standard decisions aid for early stage breast cancer.
  • Other: Post-surgical Regret Decision Aid
    Females will receive anticipated regret-augmented version for early breast cancer.
Study Arms  ICMJE
  • Active Comparator: Standard Decision Aid
    The brochure with standard information on surgery for early-stage breast cancer
    Intervention: Other: Standard Decision Aid
  • Experimental: Post-surgical Regret Decision Aid
    The brochure that incorporates additional information on the rates of regret after surgical treatment of early-stage breast cancer.
    Intervention: Other: Post-surgical Regret Decision Aid
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 29, 2015)
189
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2014
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy females ages 18 years or older

Exclusion Criteria:

  • Under age 18 years
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Healthy females ages 18 and older
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02563808
Other Study ID Numbers  ICMJE 817436
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Pennsylvania
Study Sponsor  ICMJE University of Pennsylvania
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lee Fleisher, MD UPenn, Chairman, Anesthesiology & Critical Care
PRS Account University of Pennsylvania
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP