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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

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."

Condition or disease Intervention/treatment Phase
Regret Other: Standard Decision Aid Other: Post-surgical Regret Decision Aid Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 189 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Impact of Anticipated Regret on Decision-Making in Preference Sensitive Care for Breast and Prostate Cancer
Study Start Date : March 2013
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Standard Decision Aid
The brochure with standard information on surgery for early-stage breast cancer
Other: Standard Decision Aid
Females will receive standard decisions aid for early stage breast cancer.

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.
Other: Post-surgical Regret Decision Aid
Females will receive anticipated regret-augmented version for early breast cancer.




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Healthy females ages 18 and older
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy females ages 18 years or older

Exclusion Criteria:

  • Under age 18 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02563808


Sponsors and Collaborators
University of Pennsylvania
Investigators
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Principal Investigator: Lee Fleisher, MD UPenn, Chairman, Anesthesiology & Critical Care
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02563808    
Other Study ID Numbers: 817436
First Posted: September 30, 2015    Key Record Dates
Results First Posted: May 31, 2019
Last Update Posted: May 31, 2019
Last Verified: February 2019