ClinicalTrials.gov
ClinicalTrials.gov Menu

The Role of Emotions and Regulatory Focus in Decision Making That Involves Risk Tradeoffs

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02874053
Recruitment Status : Not yet recruiting
First Posted : August 22, 2016
Last Update Posted : August 9, 2018
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Brief Summary:

Background:

People with cancer often have to make complex decisions about their treatment. For some of these decisions, they have to weigh the benefits of a treatment against its side effects. They may have to think about its potential to increase the risk of another disease. One example is hormone replacement therapy. That reduces a woman s risk of getting colorectal cancer, but it raises her risk of getting breast cancer. Researchers want to learn more about how people make tradeoff decisions like these.

Objective:

To learn about how people respond to information about hypothetical health and medical treatment options.

Eligibility:

Adults ages 18 70.

Design:

Participants will have one 30-minute visit.

Participants will complete a series of short questionnaires. These will be about their beliefs and values. Some may be about cancer and heart disease risk. Participants ages 18 to 29 will answer questions about sexual health.

Participants will write a paragraph or two about a room in their house or about a life event.

Participants will read a series of stories. These will describe different hypothetical health treatments.

The stories describe a pill that lowers the risk of one health condition, but raises the risk for another. After each story, participants will note how willing they are to take the pill.

Participants will answer questions about the information that they got. They will also answer questions about their health, beliefs, and opinions.

Participants will do 2 attention tasks computer.


Condition or disease
Cancer

Detailed Description:
Given that many preventive and therapeutic treatments for cancer lower the risk of one disease, but increase the risk of another disease (or have substantial side effects), patients and doctors often must make medical decisions that involve tradeoffs. When faced with these tradeoffs, people make decisions based on factors beyond objective probability estimates. Emotions and regulatory focus are known to influence judgment and risk propensity in non-tradeoff decision-making contexts, but little is known about their independent and joint effects on decision making in tradeoff scenarios where both options involve some degree of risk. This study aims to generate fundamental knowledge about how individuals make decisions in the context of these tradeoffs, and whether individuals with clinical disorders or at risk for clinical disorders differ from healthy individuals in their decision making. This will have immediate translational potential for applied studies of decision making among cancer patients and those at increased risk for cancer. We plan to examine the effects of discrete incidental affect on tradeoff decision making, and the role of regulatory focus as a moderator of its effect. During visits to a laboratory at the University of Pittsburgh, human subjects aged 18 to 70 will be randomly assigned to write about an emotional event (something that made them angry or afraid depending on study condition) or about a room in their house (neutral emotion condition). Then, they will read a series of scenarios that describe a pill that lowers their risk of one health condition, but raises their risk for another. After each, they will indicate their willingness to take the pill. Regulatory focus, risk perceptions, and implicit measures of risk propensity and anticipated emotions will also be assessed. Drawing on previous research, we hypothesize that participants asked to recall an angry experience will be more willing to take the pill, and that this effect will be particularly strong for those with a promotion-oriented regulatory focus. Prevention-focused participants asked to recall an experience that made them feel afraid are expected to be least willing to take the pill. We will also explore possible mechanisms underlying the emotion induction s effect on pill choice, such as shifts in risk perceptions, biased attentional focus, and implicitly measured anticipated emotions.

Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: The Role of Emotions and Regulatory Focus in Decision Making That Involves Risk Tradeoffs
Estimated Study Start Date : January 6, 2019
Estimated Primary Completion Date : November 30, 2019
Estimated Study Completion Date : November 30, 2019

Group/Cohort
Healthy
Healthy Volunteers



Primary Outcome Measures :
  1. willingness to take hypothetical pill [ Time Frame: at baseline (cross-sectional) ]
    self-reported behavioral willingness



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Community Sample
Criteria
  • INCLUSION CRITERIA:

For Study A, community members will be invited to participate if they are aged 18 to 70.

For Study B, University at Pittsburgh students will be invited to participate if they are aged 18 and over.


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): NCT02874053


Contacts
Contact: Erin M Ellis, Ph.D. (240) 276-5646 erin.ellis@nih.gov

Locations
United States, Pennsylvania
University of Pittsburgh Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15260
Contact: Edward Orehek    412-624-8267    orehek@pitt.edu   
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: William M Klein National Cancer Institute (NCI)

Publications:
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT02874053     History of Changes
Other Study ID Numbers: 999916161
16-C-N161
First Posted: August 22, 2016    Key Record Dates
Last Update Posted: August 9, 2018
Last Verified: July 10, 2018

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Risk Perceptions
Medical Tradeoffs
Regulatory Focus
Integral Affect