EgoNCT02317380
Self-Affirmation and Defensiveness to Health Messages for the Self vs. a Close Other
An observational study of Ego and Social Science, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Background: Researchers want to learn about people s beliefs and values. They also want to learn about how people respond to information about cancer risk. They have created two short studies. They have combined these studies for convenience. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Ego, Social Science, Cancer Prevention
- How many people
- 1,019 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Dec 2014to 18 Sep 2018
- 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 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For Study 1
- -Knowledge Networks panel members will be eligible if they are aged 40-70, overweight, and
- have never been diagnosed with cancer (to ensure relevance to breast and prostate cancer risk, the topic of
- the health message). Individuals will also be screened for inclusion based on whether they report having
- an opposite-sex close relationship with another adult age 40-70 who is also overweight (e.g., opposite-sex
- spouse, close friend, or family member).
- For Study 2
- -Community individuals will be subject to the same inclusion criteria.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Cancer Institute (NCI), 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Background:
- Researchers want to learn about people s beliefs and values. They also want to learn about how people respond to information about cancer risk. They have created two short studies. They have combined these studies for convenience.
Read more
Objective:
- To learn about people s beliefs and values, and about how people respond to information about cancer risk.
Eligibility:
- Adults age 40-70 who are overweight, have never had cancer, and have an opposite-sex close relationship with someone in that age group who is also overweight.
Design:
- This study will take place online or in a laboratory.
- Participants will take part in two studies. One is Values Study. The other is Cancer Risk Information.
- In Values Study, some participants will choose the most important value from a list. They will write about why that value is important to them. Others will choose the least important value from a list. They will write about why that value may be important to someone else.
- In Cancer Risk Information, participants will read a health message about a cancer risk relevant to themselves or to a close other. Some will wear special glasses that track their eye movements as they read.
- Participants will then answer questions about their beliefs about cancer risk and their intentions to lose weight.
- Both studies will take 30 minutes.
Read the detailed description
Self-affirmation, a process by which individuals reflect on cherished personal values is a potent means of augmenting the effectiveness of threatening health communications. Individuals tend to be defensive against information suggesting their behavior puts them at risk for disease or negative health. Previous evidence suggests that self-affirmation may reduce defensiveness to threatening health information, increasing openness to the message and resulting in increased disease risk perceptions, disease-related worry, intentions to engage in preventive behavior, and actual behavioral change. One mechanism by which self-affirmation may be effective is by reducing self-focus and expanding self-concept. If this is the case, self-affirmation may not be effective in reducing defensiveness against information that is threatening to one s close other. We are proposing two studies to examine whether self-affirmation is equally effective at reducing defensiveness against threatening information for the self and for a close other. These studies will not only highlight conditions under which self-affirmation is effective, but also shed light on mechanisms underlying the effect.
- Conditions
- Ego, Social Science, Cancer Prevention
- Keywords
- Self-Affirmation, Weight Loss, Self vs. Other, Cancer Risk and Prevention
- Medical subject headings
- Weight Loss
What is being measured
The primary outcome is the main question the study is designed to answer.
Intentions to lose weight/ talk to doctor
Measured: Immediately post-experiment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2014 (estimated)
- Study start13 Dec 2014
- Primary completion10 Nov 2015
- Study completion18 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for EgoStudies 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 1,019 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Rebecca A Ferrer, Ph.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02317380
- Sponsor's protocol ID
- 999915034
- Other IDs
- 15-C-N034
- Status last verified
- 18 Sep 2018
- First submitted
- 13 Dec 2014
- Last updated
- 20 Sep 2018
- Results posted
- No
Publications
Crocker J, Niiya Y, Mischkowski D. Why does writing about important values reduce defensiveness? Self-affirmation and the role of positive other-directed feelings. Psychol Sci. 2008 Jul;19(7):740-7. doi: 10.1111/j.1467-9280.2008.02150.x.
PubMed 18727791Epton T, Harris PR. Self-affirmation promotes health behavior change. Health Psychol. 2008 Nov;27(6):746-52. doi: 10.1037/0278-6133.27.6.746.
PubMed 19025270Godolphin W. Shared decision-making. Healthc Q. 2009;12 Spec No Patient:e186-90. doi: 10.12927/hcq.2009.20947.
PubMed 19667767
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-Affirmation and Defensiveness to Health Messages for the Self vs. a Close Other
- ClinicalTrials.gov ID
- NCT02317380
- Acronym / sponsor ID
- 999915034
- Conditions
- Ego, Social Science, Cancer Prevention
- Keywords
- Self-Affirmation, Weight Loss, Self vs. Other, Cancer Risk and Prevention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,019 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 13 Dec 2014
- Primary completion
- 10 Nov 2015 (actual)
- Study completion
- 18 Sep 2018 (actual)
- First posted
- 16 Dec 2014 (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:
- Researchers want to learn about people s beliefs and values. They also want to learn about how people respond to information about cancer risk. They have created two short studies. They have combined these studies for convenience.
Objective:
- To learn about people s beliefs and values, and about how people respond to information about cancer risk.
Eligibility:
- Adults age 40-70 who are overweight, have never had cancer, and have an opposite-sex close relationship with someone in that age group who is also overweight.
Design:
- This study will take place online or in a laboratory.
- Participants will take part in two studies. One is Values Study. The other is Cancer Risk Information.
- In Values Study, some participants will choose the most important value from a list. They will write about why that value is important to them. Others will choose the least important value from a list. They will write about why that value may be important to someone else.
- In Cancer Risk Information, participants will read a health message about a cancer risk relevant to themselves or to a close other. Some will wear special glasses that track their eye movements as they read.
- Participants will then answer questions about their beliefs about cancer risk and their intentions to lose weight.
- Both studies will take 30 minutes.
Detailed description
Self-affirmation, a process by which individuals reflect on cherished personal values is a potent means of augmenting the effectiveness of threatening health communications. Individuals tend to be defensive against information suggesting their behavior puts them at risk for disease or negative health. Previous evidence suggests that self-affirmation may reduce defensiveness to threatening health information, increasing openness to the message and resulting in increased disease risk perceptions, disease-related worry, intentions to engage in preventive behavior, and actual behavioral change. One mechanism by which self-affirmation may be effective is by reducing self-focus and expanding self-concept. If this is the case, self-affirmation may not be effective in reducing defensiveness against information that is threatening to one s close other. We are proposing two studies to examine whether self-affirmation is equally effective at reducing defensiveness against threatening information for the self and for a close other. These studies will not only highlight conditions under which self-affirmation is effective, but also shed light on mechanisms underlying the effect.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- For Study 1
- -Knowledge Networks panel members will be eligible if they are aged 40-70, overweight, and
- have never been diagnosed with cancer (to ensure relevance to breast and prostate cancer risk, the topic of
- the health message). Individuals will also be screened for inclusion based on whether they report having
- an opposite-sex close relationship with another adult age 40-70 who is also overweight (e.g., opposite-sex
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
Intentions to lose weight/ talk to doctor
Time frame: Immediately post-experiment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2018.
- Background: PubMed 18727791Crocker J, Niiya Y, Mischkowski D. Why does writing about important values reduce defensiveness? Self-affirmation and the role of positive other-directed feelings. Psychol Sci. 2008 Jul;19(7):740-7. doi: 10.1111/j.1467-9280.2008.02150.x.
- Background: PubMed 19025270Epton T, Harris PR. Self-affirmation promotes health behavior change. Health Psychol. 2008 Nov;27(6):746-52. doi: 10.1037/0278-6133.27.6.746.
- Background: PubMed 19667767Godolphin W. Shared decision-making. Healthc Q. 2009;12 Spec No Patient:e186-90. doi: 10.12927/hcq.2009.20947.
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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.
Rebecca A Ferrer, Ph.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ego and Social Science, run by National Cancer Institute (NCI) at 1 site in United States.
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 8 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: finished, as of the sponsor's last update on 20 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Intentions to lose weight/ talk to doctor (time frame: Immediately post-experiment). 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 NCT02317380, which also lists 3 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 20 Sep 2018.