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Trial record 1 of 1 for:    NCT02563808
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Impact of Anticipated Regret Incorporation Into Patient Decision Aids

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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Regret
Interventions Other: Standard Decision Aid
Other: Post-surgical Regret Decision Aid
Enrollment 189
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Survey: Standard Version Survey: Anticipated Regret Version
Hide Arm/Group Description

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

Survey: Standard

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

Survey: Regret

Period Title: Overall Study
Started [1] 96 88 [1]
Completed 96 88
Not Completed 0 0
[1]
A total of 5 participants enrolled were not included in final data due to data collection error
Arm/Group Title Survey: Standard Version Survey: Anticipated Regret Version Total
Hide Arm/Group Description

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

Survey: Standard

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

Survey: Regret

Total of all reporting groups
Overall Number of Baseline Participants 94 88 182
Hide Baseline Analysis Population Description
Two participants did not complete the demographic questions. As such only 94 are being analyzed.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 94 participants 88 participants 182 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
94
 100.0%
88
 100.0%
182
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 94 participants 88 participants 182 participants
22.1  (7.2) 21.8  (5.9) 22.0  (6.6)
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 94 participants 88 participants 182 participants
Female
94
 100.0%
88
 100.0%
182
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Description: Female only
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 94 participants 88 participants 182 participants
Hispanic or Latino
5
   5.3%
7
   8.0%
12
   6.6%
Not Hispanic or Latino
82
  87.2%
72
  81.8%
154
  84.6%
Unknown or Not Reported
7
   7.4%
9
  10.2%
16
   8.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 94 participants 88 participants 182 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
33
  35.1%
35
  39.8%
68
  37.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
19
  20.2%
13
  14.8%
32
  17.6%
White
30
  31.9%
24
  27.3%
54
  29.7%
More than one race
5
   5.3%
7
   8.0%
12
   6.6%
Unknown or Not Reported
7
   7.4%
9
  10.2%
16
   8.8%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 94 participants 88 participants 182 participants
94
 100.0%
88
 100.0%
182
 100.0%
1.Primary Outcome
Title Difference in Consideration of Regret
Hide Description 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.
Time Frame 11 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Survey: Standard Version Survey: Anticipated Regret Version
Hide Arm/Group Description:

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

Survey: Standard

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

Survey: Regret

Overall Number of Participants Analyzed 96 88
Measure Type: Number
Unit of Measure: participants reported regret played role
62 69
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Survey: Standard Version Survey: Anticipated Regret Version
Hide Arm/Group Description

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

Survey: Standard

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

Survey: Regret

All-Cause Mortality
Survey: Standard Version Survey: Anticipated Regret Version
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Survey: Standard Version Survey: Anticipated Regret Version
Affected / at Risk (%) Affected / at Risk (%)
Total   0/96 (0.00%)   0/88 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Survey: Standard Version Survey: Anticipated Regret Version
Affected / at Risk (%) Affected / at Risk (%)
Total   0/94 (0.00%)   0/88 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Lee Fleisher
Organization: University of Pennsylvania Hospital
Phone: 2156623738
EMail: lee.fleisher@uphs.upenn.edu
Layout table for additonal information
Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02563808    
Other Study ID Numbers: 817436
First Submitted: September 28, 2015
First Posted: September 30, 2015
Results First Submitted: October 26, 2017
Results First Posted: May 31, 2019
Last Update Posted: May 31, 2019