Peanut AllergyNCT03513965
Allergy Experience Study
A study testing Symptoms as Positive Signals Mindset and Symptoms as Side Effects Mindset in people with Peanut Allergy, run by Stanford University.
Trial summary
People who are undergoing oral immunotherapy for food allergy treatment can feel anxious about the treatment process, particularly when they have allergic responses (e.g., hives, vomiting, nausea) during the dosing process. Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Peanut Allergy
- What is being tested?
- Symptoms as Positive Signals Mindset and Symptoms as Side Effects Mindset
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 5 Jan 2017to 1 Jul 2018
- Phase
- Interventional
- 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 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- peanut-specific blood IgE level >=60 Ku/L
- or, if IgE levels <60, need to have a skin prick test greater than 3mm and IgE >5 Ku/L
Who cannot join
- having previously participated in an OIT treatment or having a family member who had done so (since the study focused on educating participants about OIT)
- being in the updose phase of allergy shots or sublingual therapy
- having been intubated or admitted to an ICU because of allergic reaction
- having a heart disorder
- diagnosed eosinophilic esophagitis
- being on oral steroids or Xolair
- diagnosed anxiety disorders, as we expected this group to have higher baseline anxiety about treatment.
About this study
Official title: Changing Mindsets About Oral Immunotherapy for Peanut Allergies Via Informing Patients That Symptoms Are a Sign of Treatment Efficacy: A Randomized Controlled Trial
People who are undergoing oral immunotherapy for food allergy treatment can feel anxious about the treatment process, particularly when they have allergic responses (e.g., hives, vomiting, nausea) during the dosing process. People may commonly believe that these symptoms are simply side effects that must be endured or avoided. However, the investigators propose that changing participants' mindsets about the meaning of symptoms-toward viewing them as a sign that the treatment is working and desensitization is increasing-during the treatment process will reduce anxiety and improve treatment outcomes.
Read the detailed description
Participants: The investigators will recruit participants who will receive treatment for peanut allergies through oral immunotherapy at the Sean N. Parker Center for Allergy \& Asthma Research.
Procedures: The investigators will divide recruited participants into two groups (random assignment). Each group will receive different messages about oral immunotherapy, one defined as "Symptoms as Side Effects Mindset" (in which symptoms are described as an unfortunate side effect of treatment). The other group will receive messages that help foster a "Symptoms as Positive Signals Mindset" (in which symptoms are described as a sign of increasing desensitization). These messages will be conveyed verbally and through activities by the study staff and participants will also receive pamphlets emphasizing these messages.
The investigators expect that adopting a "Symptoms as Positive Signals" mindset will improve OIT outcomes in five ways:
- Decrease anxiety about symptoms,
- Increase treatment completion,
- Decrease the likelihood of participants reducing dose size or skipping a dose because of anxiety about symptoms,
- Reduce the experience of non-life-threatening symptoms during the study, and
- Improve physiological treatment outcomes at the conclusion of the study, as measured through peanut blood IgG4 and IgE levels.
- Conditions
- Peanut Allergy
- Being tested
- Symptoms as Positive Signals Mindset, Symptoms as Side Effects Mindset
- Keywords
- food allergy, oral immunotherapy, mindsets, patient experience
- Medical subject headings
- Peanut Hypersensitivity, Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Symptoms as Positive Signals MindsetBehavioural
In this intervention, both arms receive the same strategies for managing symptoms and receive the same level of support regarding symptoms. However, Symptoms as Positive Signals Mindset families are additionally encouraged to think of symptoms as a positive signal that their immune system is becoming increasingly desensitized to their allergen. For each arm, four families (six to seven patients per group) meet monthly for eight months in the clinic with at least two members of the patient support team. These visits are an opportunity for families to harness peer support and ask questions, and include a variety of activities that depict symptoms in different ways.
Symptoms as Side Effects MindsetBehavioural
In this intervention, both arms receive the same strategies for managing symptoms and receive the same level of support regarding symptoms. For each arm, four families (six to seven patients per group) meet monthly for eight months in the clinic with at least two members of the patient support team. These visits are an opportunity for families to harness peer support and ask questions, and include a variety of activities that depict symptoms in different ways.
| Study group | Role | What they receive |
|---|---|---|
| Symptoms as Side Effects Mindset | Experimental | Both arms are given identical treatment instructions at their first clinic visit, including practical strategies for taking doses and managing symptoms. Families are given comprehensive instructions for recognizing life-threatening symptoms and administering epinephrine when appropriate. However, information about the implications of non-life-threatening symptoms differs between arms. At the first clinic visit, families are given verbal (e.g., provider explanations) and written information (e.g., brochures on symptom management) informing them about symptoms in different ways. In this arm, families are informed that these non-life-threatening symptoms are an unfortunate part of treatment that must be endured, similar to side effects from common medications. Receives: Behavioral: Symptoms as Side Effects Mindset |
| Symptoms as Positive Signals Mindset | Experimental | Both arms are given identical treatment instructions at their first clinic visit, including practical strategies for taking doses and managing symptoms. Families are given comprehensive instructions for recognizing life-threatening symptoms and administering epinephrine when appropriate. However, information about the implications of non-life-threatening symptoms differs between arms. At the first clinic visit, families are given verbal (e.g., provider explanations) and written information (e.g., brochures on symptom management) informing them about symptoms in different ways. In this arm, families are informed that symptoms are a sign that that their bodies are gradually increasing desensitization, similar to having sore muscles after a difficult workout. Receives: Behavioral: Symptoms as Positive Signals Mindset |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety about symptoms
Measured through daily REDCap surveys and monthly in clinic surveys; measured through parent contacting staff with concerns about symptoms
Measured: Throughout 7 months of treatment
Occurrence of non-life-threatening symptoms
Measured through daily REDCap surveys
Measured: Throughout 7 months of treatment
Treatment completion
Number of patients who complete within 2 weeks of the target end date
Measured: Up to 6 months and 2 weeks after the first clinic visit
Treatment adherence
Number of doses skipped or reduced because of anxiety
Measured: Throughout 7 months of treatment
Change in peanut blood IgG4 levels
Two blood samples assayed for IgG4 levels; one pre-treatment and one post-treatment
Measured: Change from baseline IgG4 levels after 6 months of treatment
Change in peanut blood IgE levels
Two blood samples assayed for IgE levels; one pre-treatment and one post-treatment
Measured: Change from baseline IgE levels after 6 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2018
- Study start5 Jan 2017
- Primary completion3 Aug 2017
- Study completion1 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peanut AllergyStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alia Crum, Stanford University
- Investigators
- Alia J Crum, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03513965
- Sponsor's protocol ID
- 36282
- Status last verified
- Aug 2018
- First submitted
- 12 Apr 2018
- Last updated
- 7 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: If made publicly available, all data will be de-identified and the anonymous data will be shared with researchers on the Open Science Framework
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changing Mindsets About Oral Immunotherapy for Peanut Allergies Via Informing Patients That Symptoms Are a Sign of Treatment Efficacy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03513965
- Acronym / sponsor ID
- 36282
- Conditions
- Peanut Allergy
- Keywords
- food allergy, oral immunotherapy, mindsets, patient experience
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 5 Jan 2017 (actual)
- Primary completion
- 3 Aug 2017 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 2 May 2018 (actual)
- 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.
People who are undergoing oral immunotherapy for food allergy treatment can feel anxious about the treatment process, particularly when they have allergic responses (e.g., hives, vomiting, nausea) during the dosing process. People may commonly believe that these symptoms are simply side effects that must be endured or avoided. However, the investigators propose that changing participants' mindsets about the meaning of symptoms-toward viewing them as a sign that the treatment is working and desensitization is increasing-during the treatment process will reduce anxiety and improve treatment outcomes.
Detailed description
Participants: The investigators will recruit participants who will receive treatment for peanut allergies through oral immunotherapy at the Sean N. Parker Center for Allergy \& Asthma Research.
Procedures: The investigators will divide recruited participants into two groups (random assignment). Each group will receive different messages about oral immunotherapy, one defined as "Symptoms as Side Effects Mindset" (in which symptoms are described as an unfortunate side effect of treatment). The other group will receive messages that help foster a "Symptoms as Positive Signals Mindset" (in which symptoms are described as a sign of increasing desensitization). These messages will be conveyed verbally and through activities by the study staff and participants will also receive pamphlets emphasizing these messages.
The investigators expect that adopting a "Symptoms as Positive Signals" mindset will improve OIT outcomes in five ways:
- Decrease anxiety about symptoms,
- Increase treatment completion,
- Decrease the likelihood of participants reducing dose size or skipping a dose because of anxiety about symptoms,
- Reduce the experience of non-life-threatening symptoms during the study, and
- Improve physiological treatment outcomes at the conclusion of the study, as measured through peanut blood IgG4 and IgE levels.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Symptoms as Side Effects Mindset | Experimental | Behavioral: Symptoms as Side Effects MindsetBoth arms are given identical treatment instructions at their first clinic visit, including practical strategies for taking doses and managing symptoms. Families are given comprehensive instructions for recognizing life-threatening symptoms and administering epinephrine when appropriate. However, information about the implications of non-life-threatening symptoms differs between arms. At the first clinic visit, families are given verbal (e.g., provider explanations) and written information (e.g., brochures on symptom management) informing them about symptoms in different ways. In this arm, families are informed that these non-life-threatening symptoms are an unfortunate part of treatment that must be endured, similar to side effects from common medications. |
| Symptoms as Positive Signals Mindset | Experimental | Behavioral: Symptoms as Positive Signals MindsetBoth arms are given identical treatment instructions at their first clinic visit, including practical strategies for taking doses and managing symptoms. Families are given comprehensive instructions for recognizing life-threatening symptoms and administering epinephrine when appropriate. However, information about the implications of non-life-threatening symptoms differs between arms. At the first clinic visit, families are given verbal (e.g., provider explanations) and written information (e.g., brochures on symptom management) informing them about symptoms in different ways. In this arm, families are informed that symptoms are a sign that that their bodies are gradually increasing desensitization, similar to having sore muscles after a difficult workout. |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- peanut-specific blood IgE level >=60 Ku/L
- or, if IgE levels <60, need to have a skin prick test greater than 3mm and IgE >5 Ku/L
Key exclusion criteria (7 listed)
- having previously participated in an OIT treatment or having a family member who had done so (since the study focused on educating participants about OIT)
- being in the updose phase of allergy shots or sublingual therapy
- having been intubated or admitted to an ICU because of allergic reaction
- having a heart disorder
- diagnosed eosinophilic esophagitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Symptoms as Positive Signals MindsetIn this intervention, both arms receive the same strategies for managing symptoms and receive the same level of support regarding symptoms. However, Symptoms as Positive Signals Mindset families are additionally encouraged to think of symptoms as a positive signal that their immune system is becoming increasingly desensitized to their allergen. For each arm, four families (six to seven patients per group) meet monthly for eight months in the clinic with at least two members of the patient support team. These visits are an opportunity for families to harness peer support and ask questions, and include a variety of activities that depict symptoms in different ways. | Behavioural | Symptoms as Positive Signals Mindset |
| Symptoms as Side Effects MindsetIn this intervention, both arms receive the same strategies for managing symptoms and receive the same level of support regarding symptoms. For each arm, four families (six to seven patients per group) meet monthly for eight months in the clinic with at least two members of the patient support team. These visits are an opportunity for families to harness peer support and ask questions, and include a variety of activities that depict symptoms in different ways. | Behavioural | Symptoms as Side Effects Mindset |
Primary outcome
Anxiety about symptoms
Time frame: Throughout 7 months of treatment
Measured through daily REDCap surveys and monthly in clinic surveys; measured through parent contacting staff with concerns about symptoms
Occurrence of non-life-threatening symptoms
Time frame: Throughout 7 months of treatment
Measured through daily REDCap surveys
Treatment completion
Time frame: Up to 6 months and 2 weeks after the first clinic visit
Number of patients who complete within 2 weeks of the target end date
Treatment adherence
Time frame: Throughout 7 months of treatment
Number of doses skipped or reduced because of anxiety
Change in peanut blood IgG4 levels
Time frame: Change from baseline IgG4 levels after 6 months of treatment
Two blood samples assayed for IgG4 levels; one pre-treatment and one post-treatment
Change in peanut blood IgE levels
Time frame: Change from baseline IgE levels after 6 months of treatment
Two blood samples assayed for IgE levels; one pre-treatment and one post-treatment
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 7 Aug 2018.
- Individual participant dataSharing planned: Undecided. If made publicly available, all data will be de-identified and the anonymous data will be shared with researchers on the Open Science Framework
Related trials for Peanut Allergy
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EPAP, Interviewstudy
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Efficacy of Tezepelumab in Peanut Oral Immunotherapy
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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.
Alia J Crum, PhD principal investigator
Stanford University
Questions about this trial
What is this clinical trial studying?
A study testing Symptoms as Positive Signals Mindset and Symptoms as Side Effects Mindset in people with Peanut Allergy, run by Stanford University.
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 7 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 7 Aug 2018. 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 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?
Anxiety about symptoms (time frame: Throughout 7 months of treatment). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Aug 2018.