CancerNCT02874053
The Role of Emotions and Regulatory Focus in Decision Making That Involves Risk Tradeoffs
An observational study of Cancer, run by National Cancer Institute (NCI).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cancer
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 5 Jun 2019to 17 Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Community members and students from the University of Pittsburgh.
Who may be able to join
- 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.
Who cannot join
None listed.
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Cancer
- Keywords
- Risk Perceptions, Medical Tradeoffs, Regulatory Focus, Integral Affect
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy | Healthy Volunteers |
What is being measured
The primary outcome is the main question the study is designed to answer.
willingness to take hypothetical pill
self-reported behavioral willingness
Measured: at baseline (cross-sectional)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2016 (estimated)
- Study start5 Jun 2019
- Primary completion17 Jun 2019
- Study completion17 Jun 2019
Why it stopped: PI left the NIH
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- William M Klein, Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02874053
- Sponsor's protocol ID
- 999916161
- Other IDs
- 16-C-N161
- Status last verified
- Jun 2019
- First submitted
- 17 Aug 2016
- Last updated
- 19 Jun 2019
- Results posted
- No
Publications
Lockwood P, Jordan CH, Kunda Z. Motivation by positive or negative role models: regulatory focus determines who will best inspire us. J Pers Soc Psychol. 2002 Oct;83(4):854-64.
PubMed 12374440Waters EA, Weinstein ND, Colditz GA, Emmons KM. Aversion to side effects in preventive medical treatment decisions. Br J Health Psychol. 2007 Sep;12(Pt 3):383-401. doi: 10.1348/135910706X115209.
PubMed 17640453
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Emotions and Regulatory Focus in Decision Making That Involves Risk Tradeoffs
- ClinicalTrials.gov ID
- NCT02874053
- Acronym / sponsor ID
- 999916161
- Conditions
- Cancer
- Keywords
- Risk Perceptions, Medical Tradeoffs, Regulatory Focus, Integral Affect
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: PI left the NIH
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 5 Jun 2019 (actual)
- Primary completion
- 17 Jun 2019 (actual)
- Study completion
- 17 Jun 2019 (actual)
- First posted
- 22 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy | – | –Healthy Volunteers |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Community members and students from the University of Pittsburgh.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
willingness to take hypothetical pill
Time frame: at baseline (cross-sectional)
self-reported behavioral willingness
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2019.
- Background: PubMed 12374440Lockwood P, Jordan CH, Kunda Z. Motivation by positive or negative role models: regulatory focus determines who will best inspire us. J Pers Soc Psychol. 2002 Oct;83(4):854-64.
- Background: PubMed 17640453Waters EA, Weinstein ND, Colditz GA, Emmons KM. Aversion to side effects in preventive medical treatment decisions. Br J Health Psychol. 2007 Sep;12(Pt 3):383-401. doi: 10.1348/135910706X115209.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William M Klein principal investigator
National Cancer Institute (NCI)
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by National Cancer Institute (NCI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
willingness to take hypothetical pill (time frame: at baseline (cross-sectional)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02874053, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2019.